Orange Book product · Brand (NDA)
OPVEE
NALMEFENE HYDROCHLORIDE
At a glance
May 22, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 22, 2023
3 yr 1 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
May 22, 2026
28 d ago
Today
Patent 11458091 expires
Listed drug product patent expiration.
Jul 10, 2038
in 12 yr 3 mo
Patent 12290596 expires
Listed method-of-use patent (U-4182) expiration.
Aug 04, 2042
in 16 yr 4 mo
Pharmaceutical detail
Active ingredient
NALMEFENE HYDROCHLORIDE
Strength
EQ 2.7MG BASE/SPRAY
Dosage form
SPRAY
Route
NASAL
TE code
Not listed
Application
NDA 217470
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
May 22, 2026
28 d ago
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11458091 | Jul 10, 2038 | in 12 yr 3 mo | ProductU-3630 |
| 12290596 | Aug 04, 2042 | in 16 yr 4 mo | U-4182 |
