Details for New Drug Application (NDA): 211651
NDA 211651 describes TALZENNA, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the TALZENNA profile page.
The generic ingredient in TALZENNA is talazoparib tosylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the talazoparib tosylate profile page.
The generic ingredient in TALZENNA is talazoparib tosylate. There is one drug master file entry for this compound. 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 | 0069-1195 | 0069-1195-30 | 1 BOTTLE in 1 CARTON (0069-1195-30) / 30 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | 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: | 10,189,837 | Patent Expiration: | Oct 20, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 10,780,088 | 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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