FDA Orange Book
Is there a generic for Opvee?
Opvee 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 Opvee (nalmefene). The Orange Book shows its last listed patent expires August 4, 2042 and its last listed exclusivity ends May 22, 2026.
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Opvee products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, nasal | EQ 2.7MG BASE/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 217470, held by INDIVIOR INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Opvee patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11458091 | July 10, 2038 | Drug product | U-3630 | 217470 |
| 12290596 | August 4, 2042 | Method of use | U-4182 | 217470 |
Opvee exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | May 22, 2026 | 217470 |
Opvee NDC codes
Questions
Is there a generic for Opvee?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Opvee (nalmefene). The Orange Book shows its last listed patent expires August 4, 2042 and its last listed exclusivity ends May 22, 2026.
What is the generic name for Opvee?
The active ingredient in Opvee is nalmefene, per the FDA Orange Book.
When does the Opvee patent expire?
The last patent listed for Opvee in the Orange Book expires August 4, 2042. 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.