FDA Orange Book
Generic for Soriatane
Soriatane contains acitretin. 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 Soriatane is acitretin. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Soriatane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 10MG | Discontinued | None | 5 | AB |
| capsule, oral | 17.5MG | Discontinued | None | 4 | AB |
| capsule, oral | 22.5MG | Discontinued | None | 3 | AB |
| capsule, oral | 25MG | Discontinued | None | 5 | AB |
NDA 019821, held by STIEFEL LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acitretin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 091455 | AB (A-rated, therapeutically equivalent) | April 4, 2013 | 10MG, 25MG |
| TEVA PHARMACEUTICALS USA | 202897 | AB (A-rated, therapeutically equivalent) | April 4, 2013 | 17.5MG, 22.5MG |
| SIGMAPHARM LABORATORIES LLC | 204633 | AB (A-rated, therapeutically equivalent) | May 22, 2015 | 10MG, 17.5MG, 22.5MG, 25MG |
| MYLAN PHARMACEUTICALS INC | 202148 | AB (A-rated, therapeutically equivalent) | September 10, 2015 | 10MG, 25MG |
| IMPAX LABORATORIES INC | 202552 | AB (A-rated, therapeutically equivalent) | December 23, 2015 | 10MG, 17.5MG, 22.5MG, 25MG |
| ALEMBIC PHARMACEUTICALS LTD | 217774 | AB (A-rated, therapeutically equivalent) | August 5, 2024 | 10MG, 17.5MG, 25MG |
Questions
Is there a generic for Soriatane?
Yes. The generic name for Soriatane is acitretin. 6 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 Soriatane?
The active ingredient in Soriatane is acitretin, 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.