FDA Orange Book
Generic for Rilutek
Rilutek contains riluzole. 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 Rilutek is riluzole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Rilutek products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 50MG | Discontinued | None | 4 | AB |
NDA 020599, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic riluzole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 076173 | AB (A-rated, therapeutically equivalent) | January 29, 2003 | 50MG |
| GLENMARK PHARMACEUTICALS LTD | 091394 | AB (A-rated, therapeutically equivalent) | June 18, 2013 | 50MG |
| ALKEM LABORATORIES LTD | 204048 | AB (A-rated, therapeutically equivalent) | March 30, 2016 | 50MG |
| KENTON CHEMICALS AND PHARMACEUTICALS CORP | 206045 | AB (A-rated, therapeutically equivalent) | December 9, 2019 | 50MG |
Questions
Is there a generic for Rilutek?
Yes. The generic name for Rilutek is riluzole. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Rilutek?
The active ingredient in Rilutek is riluzole, 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.