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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 217470


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NDA 217470 describes OPVEE, which is a drug marketed by Indivior 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 OPVEE profile page.

The generic ingredient in OPVEE 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 217470
Tradename:OPVEE
Applicant:Indivior
Ingredient:nalmefene hydrochloride
Patents:2
Pharmacology for NDA: 217470
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 217470
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OPVEE nalmefene hydrochloride SPRAY;NASAL 217470 NDA Indivior Inc. 12496-0003 12496-0003-2 2 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;NASALStrengthEQ 2.7MG BASE/SPRAY
Approval Date:May 22, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:May 22, 2026
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Start TrialPatent Expiration:Jul 10, 2038Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATING OPIOID OVERDOSE
Patent:⤷  Start TrialPatent Expiration:Aug 4, 2042Product Flag?Substance Flag?Delist Request?
Patented Use:EMERGENCY TREATMENT OF A KNOWN OR SUSPECTED OPIOID OVERDOSE/SYMPTOM THEREOF IN A HUMAN CAUSED BY NATURAL OR SYNTHETIC OPIOIDS, SUCH AS REMIFENTANIL-INDUCED RESPIRATORY DEPRESSION, WITH 2.7MG NALMEFENE, ADMINISTERED AS 3MG NALMEFENE HYDROCHLORIDE

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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