Generic Talzenna Availability
Last updated on Oct 9, 2024.
Talzenna is a brand name of talazoparib, approved by the FDA in the following formulation(s):
TALZENNA (talazoparib tosylate - capsule;oral)
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Manufacturer: PFIZER
Approval date: October 16, 2018
Strength(s): EQ 0.25MG BASE [RLD], EQ 1MG BASE [RLD] -
Manufacturer: PFIZER
Approval date: September 20, 2021
Strength(s): EQ 0.5MG BASE [RLD], EQ 0.75MG BASE [RLD] -
Manufacturer: PFIZER
Approval date: June 20, 2023
Strength(s): EQ 0.1MG BASE [RLD], EQ 0.35MG BASE [RLD] -
Manufacturer: PFIZER
Approval date: March 7, 2024
Strength(s): EQ 0.1MG BASE [RLD], EQ 0.25MG BASE [RLD], EQ 0.35MG BASE [RLD], EQ 0.5MG BASE [RLD], EQ 0.75MG BASE [RLD], EQ 1MG BASE [RLD]
Has a generic version of Talzenna been approved?
No. There is currently no therapeutically equivalent version of Talzenna available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Talzenna. 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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Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt
Patent 10,189,837
Issued: January 29, 2019
Inventor(s): Wang Bing & Chu Daniel & Liu Yongbo & Peng Shichun
Assignee(s): Medivation Technologies LLCProvided herein are (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt forms, including crystalline forms, and methods of their preparation. Pharmaceutical compositions comprising a (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt are also provided, as are methods of using (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt to treat a disease or condition, such as a cancer.
Patent expiration dates:
- October 20, 2031✓✓
- October 20, 2031
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Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent 10,780,088
Issued: September 22, 2020
Inventor(s): Wang Bing & Chu Daniel
Assignee(s): MEDIVATION TECHNOLOGIES LLCA compound having the structure set forth in Formula (I) and Formula (II):
Patent expiration dates:
- July 27, 2029✓
- July 27, 2029
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Patent 8,012,976
Patent expiration dates:
- October 19, 2029✓✓
- October 19, 2029
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Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent 8,420,650
Issued: April 16, 2013
Inventor(s): Wang Bing & Chu Daniel
Assignee(s): BioMarin Pharmaceutical Inc.A compound having the structure set forth in Formula (I) and Formula (II):
Patent expiration dates:
- July 27, 2029✓✓
- July 27, 2029
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[S, R, H, H, H]
Patent 8,735,392
Issued: May 27, 2014
Inventor(s): Wang Bing & Chu Daniel & Liu Yongbo & Peng Shichun
Assignee(s): BioMarin Pharmaceutical Inc.Provided herein are (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt forms, including crystalline forms, and methods of their preparation. Pharmaceutical compositions comprising a (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt are also provided, as are methods of using (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt to treat a disease or condition, such as a cancer.
Patent expiration dates:
- October 20, 2031✓✓
- October 20, 2031
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Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)
Patent 9,820,985
Issued: November 21, 2017
Inventor(s): Wang Bing & Chu Daniel
Assignee(s): Medivation Technologies LLCA compound having the structure set forth in Formula (I) and Formula (II):
Patent expiration dates:
- July 27, 2029✓
- July 27, 2029
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:
- June 20, 2026 - USE OF TALAZOPARIB IN COMBINATION WITH ENZALUTAMIDE FOR THE TREATMENT OF ADULT PATIENTS WITH HOMOLOGOUS RECOMBINATION REPAIR (HRR) GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC).
More about Talzenna (talazoparib)
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- Drug class: PARP inhibitors
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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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
