Details for New Drug Application (NDA): 214876
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NDA 214876 describes ZEJULA, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZEJULA profile page.
The generic ingredient in ZEJULA is niraparib tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the niraparib tosylate profile page.
The generic ingredient in ZEJULA is niraparib tosylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the niraparib tosylate profile page.
Summary for 214876
| Tradename: | ZEJULA |
| Applicant: | Glaxosmithkline |
| Ingredient: | niraparib tosylate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214876
Generic Entry Date for 214876*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 214876
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Suppliers and Packaging for NDA: 214876
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0909 | 0173-0909-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0909-13) |
| ZEJULA | niraparib tosylate | TABLET;ORAL | 214876 | NDA | GlaxoSmithKline LLC | 0173-0912 | 0173-0912-13 | 30 TABLET, FILM COATED in 1 BOTTLE (0173-0912-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Apr 26, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 11,091,459 | Patent Expiration: | Mar 27, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,673,877 | Patent Expiration: | Mar 27, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF TREATMENT OF OVARIAN CANCER OR FALLOPIAN TUBE CANCER | ||||||||
| Patent: | 11,673,877 | Patent Expiration: | Mar 27, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF TREATMENT OF RECURRENT OVARIAN CANCER OR FALLOPIAN TUBE CANCER ASSOCIATED WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATION | ||||||||
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