Details for New Drug Application (NDA): 211651
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NDA 211651 describes TALZENNA, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the TALZENNA profile page.
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.
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: | 5 |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 0.25MG BASE | ||||
| Approval Date: | Oct 16, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 16, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 20, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 19, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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