Orange Book product · Brand (NDA)
ZURNAI (AUTOINJECTOR)
NALMEFENE HYDROCHLORIDE
At a glance
Aug 07, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 2024
1 yr 11 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Aug 07, 2027
in 1 yr 2 mo
Patent 11857547 expires
Listed drug product patent expiration.
Nov 05, 2039
in 13 yr 7 mo
Patent 11865112 expires
Listed drug product patent expiration.
Nov 05, 2039
in 13 yr 7 mo
Pharmaceutical detail
Active ingredient
NALMEFENE HYDROCHLORIDE
Strength
EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR, SUBCUTANEOUS
TE code
Not listed
Application
NDA 218590
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)
Aug 07, 2027
in 1 yr 2 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11857547 | Nov 05, 2039 | in 13 yr 7 mo | Product |
| 11865112 | Nov 05, 2039 | in 13 yr 7 mo | ProductU-3630 |
