FDA Orange Book
Generic for Apriso
Apriso 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 Apriso is mesalamine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Apriso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 375MG | Marketed (Rx) | AB | 8 | AB |
NDA 022301, held by SALIX PHARMACEUTICALS 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 |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 207271 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 375MG |
| ALKEM LABORATORIES LTD | 214242 | AB (A-rated, therapeutically equivalent) | July 15, 2021 | 375MG |
| ZYDUS PHARMACEUTICALS USA INC | 208954 | AB (A-rated, therapeutically equivalent) | August 12, 2021 | 375MG |
| ALEMBIC PHARMACEUTICALS LTD | 216967 | AB (A-rated, therapeutically equivalent) | October 28, 2022 | 375MG |
| AUROBINDO PHARMA LTD | 214477 | AB (A-rated, therapeutically equivalent) | March 31, 2023 | 375MG |
| AMTA LABS LTD | 217533 | AB (A-rated, therapeutically equivalent) | June 6, 2023 | 375MG |
| NOVAST LABORATORIES LTD | 218410 | AB (A-rated, therapeutically equivalent) | August 22, 2024 | 375MG |
| ANNORA PHARMA PRIVATE LTD | 219864 | AB (A-rated, therapeutically equivalent) | August 13, 2025 | 375MG |
Apriso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8865688 | May 1, 2030 | Method of use | U-1310 | 022301 |
Apriso NDC codes
Questions
Is there a generic for Apriso?
Yes. The generic name for Apriso is mesalamine. 8 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 Apriso?
The active ingredient in Apriso is mesalamine, per the FDA Orange Book.
When does the Apriso patent expire?
The last patent listed for Apriso in the Orange Book expires May 1, 2030. 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.
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