Generic Brukinsa Availability
Last updated on Jun 11, 2025.
Brukinsa is a brand name of zanubrutinib, approved by the FDA in the following formulation(s):
BRUKINSA (zanubrutinib - capsule;oral)
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Manufacturer: BEONE MEDICINES USA
Approval date: November 14, 2019
Strength(s): 80MG [RLD]
Is there a generic version of Brukinsa available?
No. There is currently no therapeutically equivalent version of Brukinsa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Brukinsa. 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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Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent 10,570,139
Issued: February 25, 2020
Inventor(s): Wang Zhiwei & Guo Yunhang
Assignee(s): BEIGENE SWITZERLAND GMBHThe invention is fused heterocyclic compounds of formula (I), and salts thereof, compositions thereof, and methods of use therefor. In particular, disclosed herein are certain fused heterocyclic compounds that can be useful for inhibiting protein kinase, including Bruton's tyrosine kinase (Btk), and for treating disorders mediated thereby.
Patent expiration dates:
- April 22, 2034✓
- April 22, 2034✓
- April 22, 2034✓
- April 22, 2034✓
- April 22, 2034✓
- April 22, 2034✓
- April 22, 2034✓
- April 22, 2034
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Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent 10,927,117
Issued: February 23, 2021
Inventor(s): Wang Zhiwei & Guo Yunhang & Shi Gongyin
Assignee(s): BEIGENE SWITZERLAND GMBHThe present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Patent expiration dates:
- August 15, 2037✓✓
- August 15, 2037
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Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent 11,142,528
Issued: October 12, 2021
Inventor(s): Wang Zhiwei & Guo Yunhang
Assignee(s): BEIGENE SWITZERLAND GMBHThe invention is fused heterocyclic compounds of formula (I), and salts thereof, compositions thereof, and methods of use therefor. In particular, disclosed herein are certain fused heterocyclic compounds that can be useful for inhibiting protein kinase, including Bruton's tyrosine kinase (Btk), and for treating disorders mediated thereby.
Patent expiration dates:
- April 22, 2034✓✓
- April 22, 2034✓✓
- April 22, 2034✓✓
- April 22, 2034✓✓
- April 22, 2034✓✓
- April 22, 2034✓✓
- April 22, 2034✓✓
- April 22, 2034
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Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent 11,591,340
Issued: February 28, 2023
Inventor(s): Wang; Zhiwei et al.
Assignee(s): BEIGENE SWITZERLAND GMBH (Basel, CH)The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Patent expiration dates:
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037
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Treatment of B cell cancers using a combination comprising Btk inhibitors
Patent 11,701,357
Issued: July 18, 2023
Inventor(s): Hu; Nan et al.
Assignee(s): BEIGENE SWITZERLAND GMBH (Basel, CH)Disclosed herein is a method for the prevention, delay of progression or treatment of cancer in a subject, comprising administering to the subject in need thereof a Btk inhibitor, particularly, (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide or a pharmaceutically acceptable salt thereof, in combination with an immune checkpoint inhibitor or a targeted therapy agent. Also, disclosed a pharmaceutical combination comprising a Btk inhibitor, particularly, (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide or a pharmaceutically acceptable salt thereof, in combination with an immune checkpoint inhibitor, or a targeted therapy agent and the use thereof.
Patent expiration dates:
- June 24, 2039✓
- June 24, 2039
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Methods of treating B-cell proliferative disorder
Patent 11,786,531
Issued: October 17, 2023
Inventor(s): Paik; Jason et al.
Assignee(s): BeiGene Switzerland GmbH (Basel, CH)Provided herein is a method of treating a patient having a B-cell proliferative disorder, the method comprising administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, wherein the patient is characterized by being administered with a moderate CYP3A inducer. In one embodiment, zanubrutinib is administered at a dose of about 320 mg twice a day, or at a total daily dose of about 640 mg.
Patent expiration dates:
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043
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Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent 11,851,437
Issued: December 26, 2023
Inventor(s): Wang; Zhiwei et al.
Assignee(s): BEIGENE SWITZERLAND GMBH (Basel, CH)The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Patent expiration dates:
- August 15, 2037✓✓
- August 15, 2037
-
Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent 11,884,674
Issued: January 30, 2024
Inventor(s): Wang; Zhiwei et al.
Assignee(s): BEIGENE SWITZERLAND GMBH (Basel, CH)The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Patent expiration dates:
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037
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Methods of treating B-cell proliferative disorder
Patent 11,896,596
Issued: February 13, 2024
Inventor(s): Paik; Jason et al.
Assignee(s): BeiGene Switzerland GmbH (Basel, CH)Provided herein is a method of treating a patient having a B-cell proliferative disorder, the method comprising administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, wherein the patient is characterized by being administered with a moderate CYP3A inducer. In one embodiment, zanubrutinib is administered at a dose of about 320 mg twice a day, or at a total daily dose of about 640 mg.
Patent expiration dates:
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043
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Methods of treating B-cell proliferative disorder
Patent 11,911,386
Issued: February 27, 2024
Inventor(s): Paik; Jason et al.
Assignee(s): BeiGene Switzerland GmbH (Basel, CH)Provided herein is a method of treating a patient having a B-cell proliferative disorder, the method comprising administering to the patient zanubrutinib, or a pharmaceutically acceptable salt thereof, wherein the patient is characterized by being administered with a moderate CYP3A inducer. In one embodiment, zanubrutinib is administered at a dose of about 320 mg twice a day, or at a total daily dose of about 640 mg.
Patent expiration dates:
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043✓
- January 19, 2043
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Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent 11,970,500
Issued: April 30, 2024
Inventor(s): Wang; Zhiwei et al.
Assignee(s): BeiGene Switzerland GmbH (Basel, CH)The present invention relates to a crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetr a-hydropyrazolo[1,5-a]pyrimi dine-3-carboxamide for inhibiting Btk, methods of preparation thereof and pharmaceutical compositions, and use of the crystalline form above in the treatment of a disease, or in the manufacturing of a medicament for the treatment of a disease.
Patent expiration dates:
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037✓
- August 15, 2037
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Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent 9,447,106
Issued: September 20, 2016
Inventor(s): Wang Zhiwei & Guo Yunhang
Assignee(s): BeiGene, Ltd.The invention is substituted 4,5-dihydro- and 4,5,6,7-tetrahydro-pyrazolo[1,5-α]pyrimidine compounds of formula (I),
Patent expiration dates:
- April 22, 2034✓✓✓
- April 22, 2034✓✓✓
- April 22, 2034✓✓✓
- April 22, 2034✓✓✓
- April 22, 2034✓✓✓
- April 22, 2034✓✓✓
- April 22, 2034✓✓✓
- April 22, 2034
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 19, 2026 - TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- November 14, 2026 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
- March 7, 2027 - TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY
- August 31, 2028 - TREATMENT OF ADULT PATIENTS WITH WALDENSTRӦM’S MACROGLOBULINEMIA (WM)
- September 14, 2028 - TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
- January 19, 2030 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
- March 7, 2031 - TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY
More about Brukinsa (zanubrutinib)
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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
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