FDA Orange Book
Generic for Sfrowasa
Sfrowasa 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 Sfrowasa is mesalamine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sfrowasa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| enema, rectal | 4GM/60ML | Discontinued | None | 4 | AB |
NDA 019618, held by MYLAN SPECIALTY LP. 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 |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 076751 | AB (A-rated, therapeutically equivalent) | September 17, 2004 | 4GM/60ML |
| ENCUBE ETHICALS PRIVATE LTD | 216941 | AB (A-rated, therapeutically equivalent) | May 30, 2023 | 4GM/60ML |
| NOVITIUM PHARMA LLC | 215269 | AB (A-rated, therapeutically equivalent) | April 16, 2025 | 4GM/60ML |
| KLM LABORATORIES PRIVATE LTD | 220016 | AB (A-rated, therapeutically equivalent) | March 31, 2026 | 4GM/60ML |
Sfrowasa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7645801 | July 24, 2027 | Drug substance, Drug product | None | 019618 |
Sfrowasa NDC codes
Questions
Is there a generic for Sfrowasa?
Yes. The generic name for Sfrowasa is mesalamine. 4 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 Sfrowasa?
The active ingredient in Sfrowasa is mesalamine, per the FDA Orange Book.
When does the Sfrowasa patent expire?
The last patent listed for Sfrowasa in the Orange Book expires July 24, 2027. 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.