FDA Orange Book
Is there a generic for Zurnai (autoinjector)?
Zurnai (autoinjector) contains nalmefene. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zurnai (autoinjector) (nalmefene). The Orange Book shows its last listed patent expires November 5, 2039 and its last listed exclusivity ends August 7, 2027.
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Zurnai (autoinjector) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, subcutaneous | EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) | Marketed (Rx) | None | 0 | None |
NDA 218590, held by KNOA PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zurnai (autoinjector) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11865112 | November 5, 2039 | Drug product | U-3630 | 218590 |
| 11857547 | November 5, 2039 | Drug product | None | 218590 |
Zurnai (autoinjector) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | August 7, 2027 | 218590 |
Zurnai (autoinjector) NDC codes
Questions
Is there a generic for Zurnai (autoinjector)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zurnai (autoinjector) (nalmefene). The Orange Book shows its last listed patent expires November 5, 2039 and its last listed exclusivity ends August 7, 2027.
What is the generic name for Zurnai (autoinjector)?
The active ingredient in Zurnai (autoinjector) is nalmefene, per the FDA Orange Book.
When does the Zurnai (autoinjector) patent expire?
The last patent listed for Zurnai (autoinjector) in the Orange Book expires November 5, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.