Details for New Drug Application (NDA): 211651
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The generic ingredient in TALZENNA is talazoparib tosylate. Two suppliers are listed for this compound. Additional details are available on the talazoparib tosylate profile page.
Summary for 211651
Tradename: | TALZENNA |
Applicant: | Pfizer |
Ingredient: | talazoparib tosylate |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211651
Generic Entry Date for 211651*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 211651
Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Suppliers and Packaging for NDA: 211651
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0296 | 0069-0296-30 | 1 BOTTLE in 1 CARTON (0069-0296-30) / 30 CAPSULE in 1 BOTTLE |
TALZENNA | talazoparib tosylate | CAPSULE;ORAL | 211651 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1031 | 0069-1031-30 | 1 BOTTLE in 1 CARTON (0069-1031-30) / 30 CAPSULE in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.25MG BASE | ||||
Approval Date: | Oct 16, 2018 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
Regulatory Exclusivity Use: | 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). | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 20, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 27, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ADULT PATIENTS WITH HRR GENE-MUTATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) IN COMBINATION WITH ENZALUTAMIDE |
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