FDA Orange Book · active-ingredient family
Nalmefene hydrochloride
Nalmefene hydrochloride is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZURNAI (AUTOINJECTOR) · NDA 218590
3
Brand (NDA)
2
Generics (ANDA)
4
Listed patents
2
Exclusivity periods
Brand (NDA) products · solution, spray
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZURNAI (AUTOINJECTOR)RLD | KNOA PHARMA | NDA 218590 | — | Aug 07, 2024 | |
| OPVEERLD | INDIVIOR | NDA 217470 | — | May 22, 2023 | |
| REVEXRLD×2 | HIKMA | NDA 020459 | — | Apr 17, 1995 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NALMEFENE HYDROCHLORIDE×2 | CHENGDU SHUODE | ANDA 216007 | — | Nov 15, 2023 | |
| NALMEFENE HYDROCHLORIDE | KNOA PHARMA | ANDA 212955 | AP | Feb 08, 2022 |
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Aug 07, 2027
in 1 yr 2 mo
- NPNew product exclusivity (3 years)
May 22, 2026
28 d ago
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11458091 | Jul 10, 2038 | in 12 yr 3 mo | ProductU-3630 |
| 11865112 | Nov 05, 2039 | in 13 yr 7 mo | ProductU-3630 |
| 11857547 | Nov 05, 2039 | in 13 yr 7 mo | Product |
| 12290596 | Aug 04, 2042 | in 16 yr 4 mo | U-4182 |
Nalmefene hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
