FDA Orange Book
Generic for Radicava
Radicava contains edaravone. 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 Radicava is edaravone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Radicava products the Orange Book lists.
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Radicava products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 30MG/100ML (0.3MG/ML) | Discontinued | None | 4 | AP |
| solution, intravenous | 60MG/100ML (0.6MG/ML) | Discontinued | None | 0 | None |
NDA 209176, held by SHIONOGI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic edaravone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLAND PHARMA LTD | 216199 | AP (A-rated, therapeutically equivalent) | May 6, 2024 | 30MG/100ML (0.3MG/ML) |
| HIKMA PHARMACEUTICALS USA INC | 215508 | AP (A-rated, therapeutically equivalent) | May 6, 2024 | 30MG/100ML (0.3MG/ML) |
| SANDOZ INC | 216902 | AP (A-rated, therapeutically equivalent) | December 23, 2024 | 30MG/100ML (0.3MG/ML) |
| ZYDUS PHARMACEUTICALS USA INC | 218349 | AP (A-rated, therapeutically equivalent) | July 22, 2026 | 30MG/100ML (0.3MG/ML) |
Questions
Is there a generic for Radicava?
Yes. The generic name for Radicava is edaravone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Radicava products the Orange Book lists.
What is the generic name for Radicava?
The active ingredient in Radicava is edaravone, 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.