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Generic Brukinsa Availability

Last updated on Jan 11, 2023.

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

BRUKINSA (zanubrutinib - capsule;oral)

  • 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 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.

  • Patent 10,570,139

    Patent expiration dates:

    • April 22, 2034
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      Patent use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
    • April 22, 2034
      ✓ 
      Patent use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
    • April 22, 2034
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
  • Patent 10,927,117

    Patent expiration dates:

    • August 15, 2037
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      Drug substance
      ✓ 
      Drug product
  • Patent 11,142,528

    Patent expiration dates:

    • April 22, 2034
      ✓ 
      Patent use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
      ✓ 
      Drug product
    • April 22, 2034
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
      ✓ 
      Drug product
    • April 22, 2034
      ✓ 
      Patent use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 22, 2034
      ✓ 
      Patent use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • April 22, 2034
      ✓ 
      Patent use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
      ✓ 
      Drug substance
      ✓ 
      Drug product

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 31, 2024 - TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
    • September 14, 2024 - TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
    • November 14, 2024 - NEW CHEMICAL ENTITY
    • November 14, 2026 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
    • August 31, 2028 - TREATMENT OF ADULT PATIENTS WITH WALDENSTR¿M’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

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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