Details for New Drug Application (NDA): 218590

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NDA 218590 describes ZURNAI (AUTOINJECTOR), which is a drug marketed by Purdue Pharma Lp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ZURNAI (AUTOINJECTOR) profile page.

The generic ingredient in ZURNAI (AUTOINJECTOR) is nalmefene hydrochloride. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.

Summary for 218590

Tradename:	ZURNAI (AUTOINJECTOR)
Applicant:	Purdue Pharma Lp
Ingredient:	nalmefene hydrochloride
Patents:	2

Pharmacology for NDA: 218590

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 218590

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590	NDA	Purdue Pharma L.P.	59011-962	59011-962-01	1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS			Strength	EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
Approval Date:	Aug 7, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 7, 2027
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 5, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 5, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATING OPIOID OVERDOSE

Expired US Patents for NDA 218590

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024	⤷ Get Started Free	⤷ Get Started Free
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024	⤷ Get Started Free	⤷ Get Started Free
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024	⤷ Get Started Free	⤷ Get Started Free
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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