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 is one patent 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.
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: | 1 |
Pharmacology for NDA: 217470
| Mechanism of Action | Opioid 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: | RX | Dosage: | SPRAY;NASAL | Strength | EQ 2.7MG BASE/SPRAY | ||||
| Approval Date: | May 22, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 10, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATING OPIOID OVERDOSE | ||||||||
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