FDA Orange Book
Generic for Thiola
Thiola contains tiopronin. 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 Thiola is tiopronin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Thiola products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | AB | 1 | AB |
NDA 019569, held by MISSION PHARMACAL CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tiopronin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 214326 | AB (A-rated, therapeutically equivalent) | April 26, 2021 | 100MG |
Thiola exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-267 | Orphan drug exclusivity | June 28, 2026 | 019569 |
Thiola NDC codes
Questions
Is there a generic for Thiola?
Yes. The generic name for Thiola is tiopronin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Thiola?
The active ingredient in Thiola is tiopronin, 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.