FDA Orange Book
Generic for Revex
Revex 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
Yes. The generic name for Revex is nalmefene. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Revex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intramuscular, intravenous, subcutaneous | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | Discontinued | None | 1 | None |
| solution, intramuscular, intravenous, subcutaneous | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) | Discontinued | None | 2 | AP |
NDA 020459, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nalmefene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| KNOA PHARMA LLC | 212955 | AP (A-rated, therapeutically equivalent) | February 8, 2022 | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) |
| CHENGDU SHUODE PHARMACEUTICAL CO LTD | 216007 | None (No TE code listed) | November 15, 2023 | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML), EQ 2MG BASE/2ML (EQ 1MG BASE/ML) |
Questions
Is there a generic for Revex?
Yes. The generic name for Revex is nalmefene. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Revex?
The active ingredient in Revex is nalmefene, per the FDA Orange Book.
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.