Details for New Drug Application (NDA): 214876
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The generic ingredient in ZEJULA is niraparib tosylate. 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: | ⤷ Sign Up | Patent Expiration: | Mar 27, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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