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Last Updated: November 22, 2024

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. 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
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:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Apr 26, 2023TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2038Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TREATMENT OF OVARIAN CANCER OR FALLOPIAN TUBE CANCER
Patent:⤷  Sign UpPatent Expiration:Mar 27, 2038Product Flag?YSubstance 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.