FDA Orange Book
Generic for Gabitril
Gabitril contains tiagabine. 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 Gabitril is tiagabine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Gabitril products the Orange Book lists.
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Gabitril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 0 | None |
| tablet, oral | 12MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 16MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 20MG | Discontinued | None | 0 | None |
| tablet, oral | 2MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 4MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 6MG | Discontinued | None | 0 | None |
| tablet, oral | 8MG | Discontinued | None | 0 | None |
NDA 020646, held by CEPHALON INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tiagabine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LTD | 214816 | AB (A-rated, therapeutically equivalent) | November 16, 2021 | 12MG, 16MG, 2MG, 4MG |
Gabitril NDC codes
Questions
Is there a generic for Gabitril?
Yes. The generic name for Gabitril is tiagabine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Gabitril products the Orange Book lists.
What is the generic name for Gabitril?
The active ingredient in Gabitril is tiagabine, 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.