Generic Zejula Availability
Last updated on Apr 10, 2025.
Zejula is a brand name of niraparib, approved by the FDA in the following formulation(s):
ZEJULA (niraparib tosylate - capsule;oral)
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Manufacturer: GLAXOSMITHKLINE
Approval date: March 27, 2017
Strength(s): EQ 100MG BASE (discontinued) [RLD]
ZEJULA (niraparib tosylate - tablet;oral)
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Manufacturer: GLAXOSMITHKLINE
Approval date: April 26, 2023
Strength(s): EQ 100MG BASE [RLD], EQ 200MG BASE [RLD], EQ 300MG BASE [RLD]
Is there a generic version of Zejula available?
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.
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Niraparib compositions
Patent 11,091,459
Issued: August 17, 2021
Inventor(s): Wu; George et al.
Assignee(s): Tesaro, Inc. (Waltham, MA); Merck Sharp & Dohme Corp. (Rahway, NJ)The present invention relates to compositions comprising the compound niraparib, in particular certain solid forms of niraparib.
Patent expiration dates:
- March 27, 2038✓
- March 27, 2038
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Niraparib compositions
Patent 11,673,877
Issued: June 13, 2023
Inventor(s): Wu; George et al.
Assignee(s): Tesaro, Inc. (Wilmington, DE); Merck Sharp & Dohme Corp. (Rahway, NJ)The present invention relates to compositions comprising the compound niraparib, in particular certain solid forms of niraparib.
Patent expiration dates:
- March 27, 2038✓✓
- March 27, 2038✓✓
- March 27, 2038
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Niraparib formulations
Patent 11,730,725
Issued: August 22, 2023
Inventor(s): McGurk; Simon et al.
Assignee(s): Tesaro, Inc. (Wilmington, DE)The present invention relates to pharmaceutical tablet compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are tablet compositions containing niraparib formed by the disclosed methods, and therapeutic uses of such tablet compositions for treating various disorders and conditions.
Patent expiration dates:
- January 25, 2039✓
- January 25, 2039
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DNA damage repair inhibitors for the treatment of cancer
Patent 8,071,579
Issued: December 6, 2011
Inventor(s): Ashworth; Alan et al.
Assignee(s): The Institute of Cancer Research: Royal Cancer Hospital (London, GB); Kudos Pharmaceuticals Limited (Cambridge, GB)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✓
- August 12, 2027
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Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Patent 8,071,623
Issued: December 6, 2011
Inventor(s): Jones; Philip et al.
Assignee(s): Instituto di Ricerche di Biologia Molecolare P. Angeletti SpA (Rome, unknown)The present invention relates to compounds of formula I: ##STR00001## and pharmaceutically acceptable salts, stereoisomers or tautomers thereof which are inhibitors of poly (ADP-ribose) polymerase (PARP) and thus useful for the treatment of cancer, inflammatory diseases, reperfusion injuries, ischemic conditions, stroke, renal failure, cardiovascular diseases, vascular diseases other than cardiovascular diseases, diabetes, neurodegenerative diseases, retroviral infection, retinal damage or skin senescence and UV-induced skin damage, and as chemo- and/or radiosensitizers for cancer treatment.
Patent expiration dates:
- March 27, 2031✓✓
- March 27, 2031
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DNA damage repair inhibitors for treatment of cancer
Patent 8,143,241
Issued: March 27, 2012
Inventor(s): Ashworth; Alan et al.
Assignee(s): Kudos Pharmaceuticals Limited (Cambridge, GB); The Institute of Cancer Research (London, GB)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✓
- August 12, 2027
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[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✓
- April 24, 2029
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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 SheffieldThe 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✓
- August 4, 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:
- 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
More about Zejula (niraparib)
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Glossary
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.