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)
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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)
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Manufacturer: PHARMACYCLICS INC
Approval date: August 24, 2022
Strength(s): 70MG/ML [RLD]
IMBRUVICA (ibrutinib - tablet;oral)
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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.
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,004,746
Issued: June 26, 2018
Assignee(s): Pharmacyclics LLCDisclosed 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✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Patent 10004746*
Patent expiration dates:
- December 3, 2031
- December 3, 2031
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Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
Patent 10,010,507
Issued: July 3, 2018
Assignee(s): Pharmacyclics LLCDescribed 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✓
- March 3, 2036
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Patent 10010507*
Patent expiration dates:
- September 3, 2036
- September 3, 2036
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent 10,016,435
Issued: July 10, 2018
Assignee(s): Pharmacyclics LLCDisclosed 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✓
- June 3, 2031
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Patent 10016435*
Patent expiration dates:
- December 3, 2031
- December 3, 2031
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,106,548
Issued: October 23, 2018
Assignee(s): Pharmacyclics LLCDescribed 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✓✓
- June 3, 2033
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Patent 10106548*
Patent expiration dates:
- December 3, 2033
- December 3, 2033
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Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 10,125,140
Issued: November 13, 2018
Assignee(s): Pharmacyclics LLCDescribed 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✓✓
- June 3, 2033
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Patent 10125140*
Patent expiration dates:
- December 3, 2033
- December 3, 2033
-
Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 10,213,386
Issued: February 26, 2019
Assignee(s): Pharmacyclics LLCDescribed 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✓
- March 3, 2036
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Patent 10213386*
Patent expiration dates:
- September 3, 2036
- September 3, 2036
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,294,231
Issued: May 21, 2019
Assignee(s): Pharmacyclics LLCDescribed 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✓
- June 3, 2033
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Patent 10294231*
Patent expiration dates:
- December 3, 2033
- December 3, 2033
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 10,294,232
Issued: May 21, 2019
Assignee(s): Pharmacyclics LLCDescribed 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✓
- June 3, 2033
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Patent 10294232*
Patent expiration dates:
- December 3, 2033
- December 3, 2033
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Patent 10,463,668
Patent expiration dates:
- October 24, 2034✓
- October 24, 2034
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Patent 10463668*
Patent expiration dates:
- April 24, 2035
- April 24, 2035
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Patent 10,478,439
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Patent 10478439*
Patent expiration dates:
- December 3, 2031
- December 3, 2031
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Patent 10,653,696
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031
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Patent 10653696*
Patent expiration dates:
- December 3, 2031
- December 3, 2031
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Patent 10,695,350
Patent expiration dates:
- October 24, 2034✓
- October 24, 2034
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Patent 10695350*
Patent expiration dates:
- April 24, 2035
- April 24, 2035
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Patent 10,751,342
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031
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Patent 10751342*
Patent expiration dates:
- December 3, 2031
- December 3, 2031
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Patent 10,752,634
Patent expiration dates:
- June 3, 2033✓
- June 3, 2033
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Patent 10752634*
Patent expiration dates:
- December 3, 2033
- December 3, 2033
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Patent 10,828,259
Patent expiration dates:
- March 3, 2036✓
- March 3, 2036
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Patent 10828259*
Patent expiration dates:
- September 3, 2036
- September 3, 2036
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Patent 10,961,251
Patent expiration dates:
- June 3, 2033✓
- June 3, 2033
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Patent 10961251*
Patent expiration dates:
- December 3, 2033
- December 3, 2033
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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✓✓
- June 28, 2027✓
- December 28, 2026
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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✓✓
- May 13, 2028✓
- November 13, 2027
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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✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- June 28, 2027✓
- December 28, 2026
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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✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- June 28, 2027✓
- December 28, 2026
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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✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- April 26, 2027✓
- October 26, 2027✓
- April 26, 2027
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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✓✓
- June 28, 2027✓
- December 28, 2026
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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✓
- December 28, 2026✓
- June 28, 2027✓
- December 28, 2026
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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✓✓
- June 28, 2027✓
- December 28, 2026
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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✓
- December 3, 2031✓
- June 3, 2031
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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✓
- June 28, 2027✓
- December 28, 2026
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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✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- December 28, 2026✓
- June 28, 2027✓
- December 28, 2026
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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✓✓
- June 28, 2027✓
- December 28, 2026
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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✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- June 3, 2031✓
- December 3, 2031✓
- June 3, 2031
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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✓
- June 3, 2031✓
- December 3, 2031✓
- June 3, 2031
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Inhibitors of Bruton's tyrosine kinase
Patent 9,181,257
Issued: November 10, 2015
Assignee(s): PHARMACYCLICS LLCDisclosed 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✓
- December 28, 2026✓✓
- June 28, 2027✓
- December 28, 2026
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,296,753
Issued: March 29, 2016
Assignee(s): Pharmacyclics LLCDescribed 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✓
- October 30, 2033✓✓
- April 30, 2034✓
- October 30, 2033
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,540,382
Issued: January 10, 2017
Assignee(s): Pharmacyclics LLCDescribed 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✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- August 18, 2033✓
- February 18, 2034✓
- August 18, 2033
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Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent 9,655,857
Issued: May 23, 2017
Assignee(s): Pharmacyclics LLCDescribed 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✓
- September 3, 2036✓
- March 3, 2036
-
Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent 9,713,617
Issued: July 25, 2017
Assignee(s): Pharmacyclics LLCDescribed 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✓
- December 3, 2033✓
- June 3, 2033
-
Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent 9,725,455
Issued: August 8, 2017
Assignee(s): Pharmacyclics LLCDescribed 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✓
- December 3, 2033✓
- June 3, 2033
-
Methods of treating and preventing graft versus host disease
Patent 9,795,604
Issued: October 24, 2017
Assignee(s): Pharmacyclics LLCDescribed 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✓
- October 24, 2034✓
- October 24, 2034✓
- October 24, 2034✓
- April 24, 2035✓
- October 24, 2034
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Patent 9,801,881
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- December 3, 2031✓
- June 3, 2031
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Patent 9,801,883
Patent expiration dates:
- June 3, 2031✓
- June 3, 2031✓
- December 3, 2031✓
- June 3, 2031
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Patent 9,814,721
Patent expiration dates:
- June 3, 2031✓
- December 3, 2031✓
- June 3, 2031
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
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Term | Definition |
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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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