FDA Orange Book
Generic for Thiola EC
Thiola EC 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 EC is tiopronin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Thiola EC products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 100MG | Marketed (Rx) | AB | 3 | AB |
| tablet, delayed release, oral | 300MG | Marketed (Rx) | AB | 3 | AB |
NDA 211843, 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 |
|---|---|---|---|---|
| PH HEALTH LTD | 217219 | AB (A-rated, therapeutically equivalent) | February 24, 2023 | 100MG, 300MG |
| TORRENT PHARMACEUTICALS LTD | 216990 | AB (A-rated, therapeutically equivalent) | January 30, 2024 | 100MG, 300MG |
| TEVA PHARMACEUTICALS INC | 216456 | AB (A-rated, therapeutically equivalent) | July 22, 2024 | 100MG, 300MG |
Thiola EC patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11458104 | November 14, 2038 | Method of use | U-3441 | 211843 |
Thiola EC exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | June 28, 2026 | 211843 |
Thiola EC NDC codes
Questions
Is there a generic for Thiola EC?
Yes. The generic name for Thiola EC is tiopronin. 3 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 Thiola EC?
The active ingredient in Thiola EC is tiopronin, per the FDA Orange Book.
When does the Thiola EC patent expire?
The last patent listed for Thiola EC in the Orange Book expires November 14, 2038. A listed patent expiry date is not a generic launch date.
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.