Generic Brukinsa Availability
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: BEIGENE
Approval date: November 14, 2019
Strength(s): 80MG [RLD]
Has a generic version of Brukinsa been approved?
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 FAQs.
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 9,447,106
Issued: September 20, 2016
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), and salts thereof, compositions thereof, and methods of use therefor, such as inhibiting protein kinase, including Bruton's tyrosine kinase (Btk), and for treating disorders mediated thereby.
Patent expiration dates:
- 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:
- November 14, 2024 - NEW CHEMICAL ENTITY
- November 14, 2026 -
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about Brukinsa (zanubrutinib)
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: BTK inhibitors
- FDA Approval History
Consumer resources
Professional resources
Related treatment guides
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. |
