Details for New Drug Application (NDA): 208447

NDA 208447 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 208447

Tradename:	ZEJULA
Applicant:	Glaxosmithkline
Ingredient:	niraparib tosylate
Patents:	7

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208447

Constraining patent/regulatory exclusivity:

11,091,459

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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Mar 27, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 29, 2027
Regulatory Exclusivity Use:	INDICATED FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
Regulatory Exclusivity Expiration:	Oct 23, 2026
Regulatory Exclusivity Use:	TX OF ADULTS W/ ADV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & CANCER ASSOCIATED W/ HRD+ STATUS DEFINED BY A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
Patent:	11,091,459	Patent Expiration:	Mar 27, 2038	Product Flag?	Y	Substance Flag?		Delist Request?

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