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Generic Imbruvica Availability

Last updated on Jan 11, 2023.

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

IMBRUVICA (ibrutinib - capsule;oral)

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

IMBRUVICA (ibrutinib - suspension;oral)

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

IMBRUVICA (ibrutinib - tablet;oral)

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

Has a generic version of Imbruvica been approved?

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.

See also: Generic Drug FAQ.

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
    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 WITH 17P DELETION
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
  • Patent 10004746*

    Patent expiration dates:

    • December 3, 2031
  • Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
    Patent 10,010,507
    Issued: July 3, 2018
    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
  • Patent 10010507*

    Patent expiration dates:

    • September 3, 2036
  • Use of inhibitors of Bruton's tyrosine kinase (Btk)
    Patent 10,016,435
    Issued: July 10, 2018
    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
  • Patent 10016435*

    Patent expiration dates:

    • December 3, 2031
  • Crystalline forms of a Bruton's tyrosine kinase inhibitor
    Patent 10,106,548
    Issued: October 23, 2018
    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
  • Patent 10106548*

    Patent expiration dates:

    • December 3, 2033
  • Crystalline forms of a bruton's tyrosine kinase inhibitor
    Patent 10,125,140
    Issued: November 13, 2018
    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
  • Patent 10125140*

    Patent expiration dates:

    • December 3, 2033
  • Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
    Patent 10,213,386
    Issued: February 26, 2019
    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
  • Patent 10213386*

    Patent expiration dates:

    • September 3, 2036
  • Crystalline forms of a Bruton's tyrosine kinase inhibitor
    Patent 10,294,231
    Issued: May 21, 2019
    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
  • Patent 10294231*

    Patent expiration dates:

    • December 3, 2033
  • Crystalline forms of a Bruton's tyrosine kinase inhibitor
    Patent 10,294,232
    Issued: May 21, 2019
    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
  • Patent 10294232*

    Patent expiration dates:

    • December 3, 2033
  • Patent 10,463,668

    Patent expiration dates:

    • October 24, 2034
      ✓ 
      Patent use: TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
  • Patent 10463668*

    Patent expiration dates:

    • April 24, 2035
  • Patent 10,478,439

    Patent expiration dates:

    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA 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 MANTLE CELL LYMPHOMA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
    • 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
  • Patent 10478439*

    Patent expiration dates:

    • December 3, 2031
  • Patent 10,653,696

    Patent expiration dates:

    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
  • Patent 10653696*

    Patent expiration dates:

    • December 3, 2031
  • Patent 10,695,350

    Patent expiration dates:

    • October 24, 2034
      ✓ 
      Patent use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY
  • Patent 10695350*

    Patent expiration dates:

    • April 24, 2035
  • Patent 10,751,342

    Patent expiration dates:

    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
  • Patent 10751342*

    Patent expiration dates:

    • December 3, 2031
  • Patent 10,752,634

    Patent expiration dates:

    • June 3, 2033
      ✓ 
      Drug product
  • Patent 10752634*

    Patent expiration dates:

    • December 3, 2033
  • Patent 10,828,259

    Patent expiration dates:

    • March 3, 2036
      ✓ 
      Drug product
  • Patent 10828259*

    Patent expiration dates:

    • September 3, 2036
  • Patent 10,961,251

    Patent expiration dates:

    • June 3, 2033
      ✓ 
      Drug product
  • Patent 10961251*

    Patent expiration dates:

    • December 3, 2033
  • Inhibitors of bruton's tyrosine kinase
    Patent 7,514,444
    Issued: April 7, 2009
    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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of bruton's tyrosine kinase
    Patent 8,008,309
    Issued: August 30, 2011
    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:

    • November 13, 2027
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • May 13, 2028
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 8,476,284
    Issued: July 2, 2013
    Assignee(s): Pharmacyclics, Inc.

    Disclosed herein are compounds, including compounds having the Formula (A) where A, R1, R2, R3, and R4 are as defined in the specification, 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 MARGINAL ZONE LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 8,497,277
    Issued: July 30, 2013
    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 MARGINAL ZONE LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • 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 CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of bruton's tyrosine kinase
    Patent 8,563,563
    Issued: October 22, 2013
    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 SMALL LYMPHOCYTIC LEUKEMIA
    • April 26, 2027
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • April 26, 2027
      ✓ 
      Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
    • April 26, 2027
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • April 26, 2027
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
    • April 26, 2027
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
    • October 26, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of bruton'S tyrosine kinase
    Patent 8,697,711
    Issued: April 15, 2014
    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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 8,703,780
    Issued: April 22, 2014
    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 CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 8,735,403
    Issued: May 27, 2014
    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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Use of inhibitors of bruton's tyrosine kinase (Btk)
    Patent 8,754,090
    Issued: June 17, 2014
    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
    • December 3, 2031
      ✓ 
      Pediatric exclusivity
  • Inhibitors of bruton's tyrosine kinase
    Patent 8,754,091
    Issued: June 17, 2014
    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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 8,952,015
    Issued: February 10, 2015
    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) 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 WALDENSTROM'S MACROGLOBULINEMIA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • December 28, 2026
      ✓ 
      Patent use: TREATMENT OF MANTLE CELL 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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 8,957,079
    Issued: February 17, 2015
    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: 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 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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Use of inhibitors of Bruton's tyrosine kinase (Btk)
    Patent 8,999,999
    Issued: April 7, 2015
    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 SMALL LYMPHOCYTIC LEUKEMIA
    • 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 CHRONIC LYMPHOCYTIC LEUKEMIA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA 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
    • December 3, 2031
      ✓ 
      Pediatric exclusivity
  • Use of inhibitors of Bruton's tyrosine kinase (Btk)
    Patent 9,125,889
    Issued: September 8, 2015
    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
    • December 3, 2031
      ✓ 
      Pediatric exclusivity
  • Inhibitors of Bruton's tyrosine kinase
    Patent 9,181,257
    Issued: November 10, 2015
    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
    • June 28, 2027
      ✓ 
      Pediatric exclusivity
  • Crystalline forms of a Bruton's tyrosine kinase inhibitor
    Patent 9,296,753
    Issued: March 29, 2016
    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
    • April 30, 2034
      ✓ 
      Pediatric exclusivity
  • Crystalline forms of a Bruton's tyrosine kinase inhibitor
    Patent 9,540,382
    Issued: January 10, 2017
    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 SMALL LYMPHOCYTIC LYMPHOMA
    • August 18, 2033
      ✓ 
      Patent use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
    • August 18, 2033
      ✓ 
      Patent use: TREATMENT OF MANTLE CELL LYMPHOMA
    • August 18, 2033
      ✓ 
      Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
    • August 18, 2033
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • February 18, 2034
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      Pediatric exclusivity
  • Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
    Patent 9,655,857
    Issued: May 23, 2017
    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
    • September 3, 2036
      ✓ 
      Pediatric exclusivity
  • Crystalline forms of a Bruton's tyrosine kinase inhibitor
    Patent 9,713,617
    Issued: July 25, 2017
    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
    • December 3, 2033
      ✓ 
      Pediatric exclusivity
  • Crystalline forms of a bruton's tyrosine kinase inhibitor
    Patent 9,725,455
    Issued: August 8, 2017
    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
    • December 3, 2033
      ✓ 
      Pediatric exclusivity
  • Methods of treating and preventing graft versus host disease
    Patent 9,795,604
    Issued: October 24, 2017
    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 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 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 CHRONIC GRAFT-VERSUS-HOST DISEASE
    • 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
    • April 24, 2035
      ✓ 
      Pediatric exclusivity
  • Patent 9,801,881

    Patent expiration dates:

    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
    • December 3, 2031
      ✓ 
      Pediatric exclusivity
  • Patent 9,801,883

    Patent expiration dates:

    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA
    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
    • December 3, 2031
      ✓ 
      Pediatric exclusivity
  • Patent 9,814,721

    Patent expiration dates:

    • June 3, 2031
      ✓ 
      Patent use: TREATMENT OF MARGINAL ZONE LYMPHOMA
    • 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:

    • January 25, 2022 - INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
    • January 29, 2022 - TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
    • March 4, 2023 - INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY)
    • May 6, 2023 - FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
    • January 18, 2024 - TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
    • August 2, 2024 - TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
    • August 24, 2025 - NEW PATIENT POPULATION
    • August 24, 2025 - NEW PRODUCT
    • February 24, 2026 - PEDIATRIC EXCLUSIVITY

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

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