Drug
Who makes nalmefene hydrochloride?
2 companies list nalmefene hydrochloride as a human prescription drug, including under the names OPVEE, Zurnai. Forms: injection, solution; spray. Routes: intramuscular, intravenous, nasal, subcutaneous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing nalmefene hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Knoa Pharma LLCUnited States | injection, solution | ANDA, NDAANDA212955, NDA218590 | 2 | 1 |
| Indivior Inc.United States | spray | NDANDA217470 | 1 | 2 |
Bulk ingredient listings
- Purisys LLCUnited States · 1 NDC
- SpecGx LLCUnited States · 1 NDC
Orange Book patents
4 unexpired patents list nalmefene hydrochloride as the active ingredient, expiring between Jul 2038 and Aug 2042. Application holders: INDIVIOR INC, KNOA PHARMA LLC.
Enquiry
Common questions
- Who makes nalmefene hydrochloride?
- 2 companies list nalmefene hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Knoa Pharma LLC, Indivior Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic OPVEE?
- 1 company lists nalmefene hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies nalmefene hydrochloride active ingredient?
- 2 companies list nalmefene hydrochloride as a bulk ingredient, including Purisys LLC, SpecGx LLC.