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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205787

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NDA 205787 describes EVZIO, which is a drug marketed by Kaleo Inc and is included in two NDAs. There are twenty-two patents protecting this drug. Additional details are available on the EVZIO profile page.

The generic ingredient in EVZIO is naloxone hydrochloride. There are twelve drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.

Summary for 205787

Tradename:	EVZIO
Applicant:	Kaleo Inc
Ingredient:	naloxone hydrochloride
Patents:	21

Medical Subject Heading (MeSH) Categories for 205787

Narcotic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS			Strength	0.4MG/0.4ML (0.4MG/0.4ML)
Approval Date:	Apr 3, 2014	TE:		RLD:	Yes
Patent:	10,143,972	Patent Expiration:	May 24, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE
Patent:	10,220,158	Patent Expiration:	Mar 20, 2035	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE
Patent:	10,322,239	Patent Expiration:	Feb 28, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	USE OF A DELIVERY DEVICE TO ADMINISTER A DOSE OF NALOXONE

Expired US Patents for NDA 205787

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	8,361,029	⤷ Get Started Free
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	10,314,977	⤷ Get Started Free
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	7,918,823	⤷ Get Started Free
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	8,016,788	⤷ Get Started Free
Kaleo Inc	EVZIO	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	205787-001	Apr 3, 2014	9,278,182	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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