FDA Orange Book
Generic for Lialda
Lialda contains mesalamine. 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 Lialda is mesalamine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lialda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, delayed release, oral | 1.2GM | Marketed (Rx) | AB | 5 | AB |
NDA 022000, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic mesalamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 091640 | AB (A-rated, therapeutically equivalent) | June 5, 2017 | 1.2GM |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 203817 | AB (A-rated, therapeutically equivalent) | March 23, 2018 | 1.2GM |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 211858 | AB (A-rated, therapeutically equivalent) | January 25, 2019 | 1.2GM |
| SINOTHERAPEUTICS INC | 217337 | AB (A-rated, therapeutically equivalent) | May 12, 2023 | 1.2GM |
| ANNORA PHARMA PRIVATE LTD | 216334 | AB (A-rated, therapeutically equivalent) | February 5, 2024 | 1.2GM |
Lialda NDC codes
Questions
Is there a generic for Lialda?
Yes. The generic name for Lialda is mesalamine. 5 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 Lialda?
The active ingredient in Lialda is mesalamine, 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.
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