Generic Imbruvica Availability

Last updated on Jun 11, 2025.

Imbruvica is a brand name of ibrutinib, approved by the FDA in the following formulation(s):

IMBRUVICA (ibrutinib - capsule;oral)

Manufacturer: PHARMACYCLICS LLC
Approval date: November 13, 2013
Strength(s): 140MG ^[RLD]
Manufacturer: PHARMACYCLICS LLC
Approval date: December 20, 2017
Strength(s): 70MG ^[RLD]

IMBRUVICA (ibrutinib - suspension;oral)

Manufacturer: PHARMACYCLICS LLC
Approval date: August 24, 2022
Strength(s): 70MG/ML ^[RLD]

IMBRUVICA (ibrutinib - tablet;oral)

Manufacturer: PHARMACYCLICS LLC
Approval date: February 16, 2018
Strength(s): 140MG ^[RLD], 280MG ^[RLD], 420MG ^[RLD], 560MG (discontinued) ^[RLD]

Is there a generic version of Imbruvica available?

No. There is currently no therapeutically equivalent version of Imbruvica available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Imbruvica. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,004,746
Issued: June 26, 2018
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10004746*PE
Issued: June 26, 2018
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
Patent 10,010,507
Issued: July 3, 2018
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- March 3, 2036
  ✓
  Drug product
Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
Patent 10010507*PE
Issued: July 3, 2018
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- September 3, 2036
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,016,435
Issued: July 10, 2018
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10016435*PE
Issued: July 10, 2018
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,106,548
Issued: October 23, 2018
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug substance
  ✓
  Drug product
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10106548*PE
Issued: October 23, 2018
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 10,125,140
Issued: November 13, 2018
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug substance
  ✓
  Drug product
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 10125140*PE
Issued: November 13, 2018
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 10,213,386
Issued: February 26, 2019
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- March 3, 2036
  ✓
  Drug product
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 10213386*PE
Issued: February 26, 2019
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- September 3, 2036
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,294,231
Issued: May 21, 2019
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug product
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10294231*PE
Issued: May 21, 2019
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,294,232
Issued: May 21, 2019
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug product
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10294232*PE
Issued: May 21, 2019
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
Methods of treating and preventing graft versus host disease
Patent 10,463,668
Issued: November 5, 2019
Inventor(s): Byrd John C. & Dubovsky Jason A. & Muthusamy Natarajan & Johnson Amy J. & Miklos David
Assignee(s): Pharmacyclics LLC
Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- October 24, 2034
  ✓
  Patent use: TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
- October 24, 2034
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Methods of treating and preventing graft versus host disease
Patent 10463668*PE
Issued: November 5, 2019
Inventor(s): Byrd John C. & Dubovsky Jason A. & Muthusamy Natarajan & Johnson Amy J. & Miklos David
Assignee(s): Pharmacyclics LLC
Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- April 24, 2035
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 10,478,439
Issued: November 19, 2019
Inventor(s): Honigberg Lee & Loury David J.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- June 3, 2031
  ✓
  Patent use: TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
- June 3, 2031
  ✓
  Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 10478439*PE
Issued: November 19, 2019
Inventor(s): Honigberg Lee & Loury David J.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent 10,653,696
Issued: May 19, 2020
Inventor(s): Buggy Joseph J. & Fyfe Gwen & Honigberg Lee & Loury David J.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent 10653696*PE
Issued: May 19, 2020
Inventor(s): Buggy Joseph J. & Fyfe Gwen & Honigberg Lee & Loury David J.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
Methods of treating and preventing graft versus host disease
Patent 10,695,350
Issued: June 30, 2020
Inventor(s): Byrd John C. & Dubovsky Jason A. & Muthusamy Natarajan & Johnson Amy J. & Miklos David
Assignee(s): Pharmacyclics LLC
Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- October 24, 2034
  ✓
  Patent use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
- October 24, 2034
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Methods of treating and preventing graft versus host disease
Patent 10695350*PE
Issued: June 30, 2020
Inventor(s): Byrd John C. & Dubovsky Jason A. & Muthusamy Natarajan & Johnson Amy J. & Miklos David
Assignee(s): Pharmacyclics LLC
Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- April 24, 2035
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,751,342
Issued: August 25, 2020
Inventor(s): Buggy Joseph J. & Fyfe Gwen & Honigberg Lee & Loury David J.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10751342*PE
Issued: August 25, 2020
Inventor(s): Buggy Joseph J. & Fyfe Gwen & Honigberg Lee & Loury David J.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
Crystalline forms of a brutons tyrosine kinase inhibitor
Patent 10,752,634
Issued: August 25, 2020
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug product
Crystalline forms of a brutons tyrosine kinase inhibitor
Patent 10752634*PE
Issued: August 25, 2020
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 10,828,259
Issued: November 10, 2020
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- March 3, 2036
  ✓
  Drug product
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 10828259*PE
Issued: November 10, 2020
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- September 3, 2036
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,961,251
Issued: March 30, 2021
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug product
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10961251*PE
Issued: March 30, 2021
Inventor(s): Purro Norbert & Smyth Mark S. & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
Use of inhibitors of Brutons tyrosine kinase (Btk)
Patent 11,672,803
Issued: June 13, 2023
Inventor(s): Buggy; Joseph J.
Assignee(s): Pharmacyclics LLC (North Chicago, IL)
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Formulations/compositions comprising ibrutinib
Patent 12,201,690
Issued: January 21, 2025
Inventor(s): Bernini; Maristella et al.
Assignee(s): Janssen Pharmaceutica NV (Beerse, BE)
Disclosed are formulations/compositions comprising ibrutinib: ##STR00001##
as well as processes for preparing such formulations/compositions and methods of treatment of a disease or condition that comprises the use of such formulations/compositions.
Patent expiration dates:
- June 14, 2039
  ✓
  Drug product
Inhibitors of bruton's tyrosine kinase
Patent 7,514,444
Issued: April 7, 2009
Inventor(s): Honigberg; Lee et al.
Assignee(s): Pharmacyclics, Inc. (Sunnyvale, CA)
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug substance
  ✓
  Drug product
Inhibitors of bruton's tyrosine kinase
Patent 7514444*PED
Issued: April 7, 2009
Inventor(s): Honigberg; Lee et al.
Assignee(s): Pharmacyclics, Inc. (Sunnyvale, CA)
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of bruton's tyrosine kinase
Patent 8,008,309
Issued: August 30, 2011
Inventor(s): Honigberg; Lee et al.
Assignee(s): Pharmacyclics, Inc. (Sunnyvale, CA)
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- November 13, 2027
  ✓
  Drug substance
  ✓
  Drug product
Inhibitors of bruton's tyrosine kinase
Patent 8008309*PED
Issued: August 30, 2011
Inventor(s): Honigberg; Lee et al.
Assignee(s): Pharmacyclics, Inc. (Sunnyvale, CA)
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- May 13, 2028
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 8,476,284
Issued: July 2, 2013
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds, including compounds having the Formula (A)
Patent expiration dates:
- December 28, 2026
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
- December 28, 2026
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent 8476284*PED
Issued: July 2, 2013
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds, including compounds having the Formula (A)
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 8,497,277
Issued: July 30, 2013
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
- December 28, 2026
  ✓
  Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent 8497277*PED
Issued: July 30, 2013
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of bruton's tyrosine kinase
Patent 8,563,563
Issued: October 22, 2013
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- April 26, 2027
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- April 26, 2027
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- April 26, 2027
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- April 26, 2027
  ✓
  Patent use: TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA
- April 26, 2027
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- April 26, 2027
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- April 26, 2027
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- April 26, 2027
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- April 26, 2027
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
- April 26, 2027
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- April 26, 2027
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Inhibitors of bruton's tyrosine kinase
Patent 8563563*PED
Issued: October 22, 2013
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- October 26, 2027
  ✓
  Pediatric exclusivity
Inhibitors of bruton'S tyrosine kinase
Patent 8,697,711
Issued: April 15, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug substance
  ✓
  Drug product
Inhibitors of bruton'S tyrosine kinase
Patent 8697711*PED
Issued: April 15, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 8,703,780
Issued: April 22, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
Patent 8703780*PED
Issued: April 22, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 8,735,403
Issued: May 27, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug substance
  ✓
  Drug product
Inhibitors of Bruton's tyrosine kinase
Patent 8735403*PED
Issued: May 27, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 8,754,090
Issued: June 17, 2014
Inventor(s): Buggy Joseph J. & Fyfe Gwen & Loury David J.
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 8754090*PED
Issued: June 17, 2014
Inventor(s): Buggy Joseph J. & Fyfe Gwen & Loury David J.
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
  ✓
  Pediatric exclusivity
Inhibitors of bruton's tyrosine kinase
Patent 8,754,091
Issued: June 17, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug product
Inhibitors of bruton's tyrosine kinase
Patent 8754091*PED
Issued: June 17, 2014
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds, including compounds having the structure of Formula (A), (B), (C), and (D), as described in further detail herein, that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 8,952,015
Issued: February 10, 2015
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk, such as those having the structure of Formula (A)
Patent expiration dates:
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
- December 28, 2026
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- December 28, 2026
  ✓
  Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
- December 28, 2026
  ✓
  Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Inhibitors of Bruton's tyrosine kinase
Patent 8952015*PED
Issued: February 10, 2015
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk, such as those having the structure of Formula (A)
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 8,957,079
Issued: February 17, 2015
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk, such as those having the structure:
Patent expiration dates:
- December 28, 2026
  ✓
  Drug substance
  ✓
  Drug product
Inhibitors of Bruton's tyrosine kinase
Patent 8957079*PED
Issued: February 17, 2015
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are compounds that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk, such as those having the structure:
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 8,999,999
Issued: April 7, 2015
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 8999999*PED
Issued: April 7, 2015
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
  ✓
  Pediatric exclusivity
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 9,125,889
Issued: September 8, 2015
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- June 3, 2031
  ✓
  Patent use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 9125889*PED
Issued: September 8, 2015
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics, Inc.
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
  ✓
  Pediatric exclusivity
Inhibitors of Bruton's tyrosine kinase
Patent 9,181,257
Issued: November 10, 2015
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): PHARMACYCLICS LLC
Disclosed herein are pyrazolo[3,4-d]pyrimidines that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 28, 2026
  ✓
  Drug substance
- December 28, 2026
  ✓
  Drug substance
  ✓
  Drug product
Inhibitors of Bruton's tyrosine kinase
Patent 9181257*PED
Issued: November 10, 2015
Inventor(s): Honigberg Lee & Verner Erik & Pan Zhengying
Assignee(s): PHARMACYCLICS LLC
Disclosed herein are pyrazolo[3,4-d]pyrimidines that form covalent bonds with Bruton's tyrosine kinase (Btk). Also described are irreversible inhibitors of Btk. Methods for the preparation of the compounds are disclosed. Also disclosed are pharmaceutical compositions that include the compounds. Methods of using the Btk inhibitors are disclosed, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 28, 2027
  ✓
  Pediatric exclusivity
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,296,753
Issued: March 29, 2016
Inventor(s): Smyth Mark & Goldman Erick & Wirth David D. & Purro Norbert
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- October 30, 2033
  ✓
  Drug substance
- October 30, 2033
  ✓
  Drug substance
  ✓
  Drug product
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9296753*PED
Issued: March 29, 2016
Inventor(s): Smyth Mark & Goldman Erick & Wirth David D. & Purro Norbert
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- April 30, 2034
  ✓
  Pediatric exclusivity
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,540,382
Issued: January 10, 2017
Inventor(s): Purro Norbert & Smyth Mark & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- August 18, 2033
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- August 18, 2033
  ✓
  Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
- August 18, 2033
  ✓
  Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
- August 18, 2033
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9540382*PED
Issued: January 10, 2017
Inventor(s): Purro Norbert & Smyth Mark & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- February 18, 2034
  ✓
  Pediatric exclusivity
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 9,655,857
Issued: May 23, 2017
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- March 3, 2036
  ✓
  Drug product
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 9655857*PED
Issued: May 23, 2017
Inventor(s): Chong Ching W. & Kuehl Robert & Tan Heow & Atluri Harisha
Assignee(s): Pharmacyclics LLC
Described herein are pharmaceutical formulations of Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one. Also disclosed are methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- September 3, 2036
  ✓
  Pediatric exclusivity
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,713,617
Issued: July 25, 2017
Inventor(s): Purro Norbert & Smyth Mark Stephen & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug product
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9713617*PED
Issued: July 25, 2017
Inventor(s): Purro Norbert & Smyth Mark Stephen & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
  ✓
  Pediatric exclusivity
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 9,725,455
Issued: August 8, 2017
Inventor(s): Purro Norbert & Smyth Mark Stephen & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- June 3, 2033
  ✓
  Drug substance
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 9725455*PED
Issued: August 8, 2017
Inventor(s): Purro Norbert & Smyth Mark Stephen & Goldman Erick & Wirth David D.
Assignee(s): Pharmacyclics LLC
Described herein is the Bruton's tyrosine kinase (Btk) inhibitor 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one, including crystalline forms, solvates and pharmaceutically acceptable salts thereof. Also disclosed are pharmaceutical compositions that include the Btk inhibitor, as well as methods of using the Btk inhibitor, alone or in combination with other therapeutic agents, for the treatment of autoimmune diseases or conditions, heteroimmune diseases or conditions, cancer, including lymphoma, and inflammatory diseases or conditions.
Patent expiration dates:
- December 3, 2033
  ✓
  Pediatric exclusivity
Methods of treating and preventing graft versus host disease
Patent 9,795,604
Issued: October 24, 2017
Inventor(s): Byrd John C. & Dubovsky Jason A. & Muthusamy Natarajan & Johnson Amy Jo & Miklos David
Assignee(s): Pharmacyclics LLC
Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- October 24, 2034
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- October 24, 2034
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- October 24, 2034
  ✓
  Patent use: TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- October 24, 2034
  ✓
  Patent use: TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE
Methods of treating and preventing graft versus host disease
Patent 9795604*PED
Issued: October 24, 2017
Inventor(s): Byrd John C. & Dubovsky Jason A. & Muthusamy Natarajan & Johnson Amy Jo & Miklos David
Assignee(s): Pharmacyclics LLC
Described herein are methods for treating and preventing graft versus host disease using ACK inhibitors. The methods include administering to an individual in need thereof an ACK inhibitor such as ibrutinib for treating and preventing graft versus host disease.
Patent expiration dates:
- April 24, 2035
  ✓
  Pediatric exclusivity
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent 9,801,881
Issued: October 31, 2017
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent 9801881*PED
Issued: October 31, 2017
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
  ✓
  Pediatric exclusivity
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 9,801,883
Issued: October 31, 2017
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- June 3, 2031
  ✓
  Patent use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
- June 3, 2031
  ✓
  Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent 9801883*PED
Issued: October 31, 2017
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
  ✓
  Pediatric exclusivity
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent 9,814,721
Issued: November 14, 2017
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- June 3, 2031
  ✓
  Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent 9814721*PED
Issued: November 14, 2017
Inventor(s): Buggy Joseph J. & Elias Laurence & Fyfe Gwen & Hedrick Eric & Loury David J. & Mody Tarak D.
Assignee(s): Pharmacyclics LLC
Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Patent expiration dates:
- December 3, 2031
  ✓
  Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

Exclusivity expiration dates:
- August 2, 2024 - TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
- February 2, 2025 - PEDIATRIC EXCLUSIVITY
- August 24, 2025 - ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
- August 24, 2025 - NEW PRODUCT
- August 24, 2025 - NEW PATIENT POPULATION
- February 24, 2026 - PEDIATRIC EXCLUSIVITY
- August 24, 2029 - TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
- February 24, 2030 - PEDIATRIC EXCLUSIVITY

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Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

6.6 / 10

69 Reviews

Images

Pill ibr 420 is Imbruvica 420 mg — Imbruvica 420 mg (ibr 420)