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Generic Zejula Availability

Last updated on Nov 7, 2023.

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

ZEJULA (niraparib tosylate - capsule;oral)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: March 27, 2017
    Strength(s): EQ 100MG BASE [RLD]

ZEJULA (niraparib tosylate - tablet;oral)

  • Manufacturer: GLAXOSMITHKLINE
    Approval date: April 26, 2023
    Strength(s): EQ 100MG BASE [RLD], EQ 200MG BASE [RLD], EQ 300MG BASE [RLD]

Has a generic version of Zejula been approved?

No. There is currently no therapeutically equivalent version of Zejula available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zejula. 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.

  • Niraparib compositions
    Patent 11,091,459
    Issued: August 17, 2021
    Inventor(s): Wu George & Chaber John & McKeown Arlene E. & Foley Jennifer R.

    The present invention relates to compositions comprising the compound niraparib, in particular certain solid forms of niraparib.

    Patent expiration dates:

    • March 27, 2038
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      Drug product
  • Patent 11,673,877
    Issued: November 30, -0001

    Patent expiration dates:

    • March 27, 2038
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      Patent use: A METHOD OF TREATMENT OF OVARIAN CANCER OR FALLOPIAN TUBE CANCER
      ✓ 
      Drug product
    • March 27, 2038
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      Patent use: A METHOD OF TREATMENT OF RECURRENT OVARIAN CANCER OR FALLOPIAN TUBE CANCER ASSOCIATED WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATION
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      Drug product
  • Patent 11,730,725
    Issued: November 30, -0001

    Patent expiration dates:

    • January 4, 2039
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      Drug product
  • Patent 8,071,579
    Issued: November 30, -0001

    Patent expiration dates:

    • August 12, 2027
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      Patent use: A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS
  • Patent 8,071,623
    Issued: November 30, -0001

    Patent expiration dates:

    • March 27, 2031
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      Drug substance
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      Drug product
  • DNA damage repair inhibitors for treatment of cancer
    Patent 8,143,241
    Issued: March 27, 2012
    Inventor(s): Ashworth Alan & Jackson Stephen & Martin Niall & Smith Graeme & "OConnor Mark"

    The present invention relates to the recognition that inhibition of the base excision repair pathway is selectively lethal in cells which are deficient in HR dependent DNA DSB repair. Methods and means relating to the treatment of cancers which are deficient in HR dependent DNA DSB repair using inhibitors which target base excision repair components, such as PARP, is provided herein.

    Patent expiration dates:

    • August 12, 2027
      ✓ 
      Patent use: A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS
  • [S, H]
    Patent 8,436,185
    Issued: May 7, 2013
    Inventor(s): Foley Jennifer R. & Wilson Robert Darrin
    Assignee(s): Merck Sharp & Dohme Corp.

    The present invention relates to pharmaceutically acceptable salts of an amide substituted indazole which are inhibitors of the enzyme poly(ADP-ribose)polymerase (PARP), previously known as poly(ADP-ribose)synthase and poly(ADP-ribosyl) transferase. The compounds of the present invention are useful as mono-therapies in tumors with specific defects in DNA-repair pathways and as enhancers of certain DNA-damaging agents such as anticancer agents and radiotherapy. Further, the compounds of the present invention are useful for reducing cell necrosis (in stroke and myocardial infarction), down regulating inflammation and tissue injury, treating retroviral infections and protecting against the toxicity of chemotherapy.

    Patent expiration dates:

    • April 24, 2029
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      Drug substance
  • Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
    Patent 8,859,562
    Issued: October 14, 2014
    Inventor(s): Helleday Thomas
    Assignee(s): The University of Sheffield

    The present invention relates to the use of an agent that inhibits the activity of an enzyme that mediates repair of a DNA strand break in the manufacture of a medicament for the treatment of diseases caused by a defect in a gene that mediates homologous recombination.

    Patent expiration dates:

    • August 4, 2031
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      Patent use: A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS

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:

    • April 29, 2023 - MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
    • March 27, 2024 - INDICATED FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • October 23, 2026 - TX OF ADULTS W/ ADV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & CANCER ASSOCIATED W/ HRD+ STATUS DEFINED BY A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
    • April 29, 2027 - INDICATED FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY

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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