FDA Orange Book
Generic for Canasa
Canasa 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 Canasa is mesalamine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Canasa products the Orange Book lists.
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Canasa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suppository, rectal | 1GM | Marketed (Rx) | AB | 8 | AB |
| suppository, rectal | 500MG | Discontinued | None | 0 | None |
NDA 021252, held by ABBVIE 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 |
|---|---|---|---|---|
| QUAGEN PHARMACEUTICALS LLC | 204354 | AB (A-rated, therapeutically equivalent) | November 24, 2015 | 1GM |
| RISING PHARMA HOLDINGS INC | 207448 | AB (A-rated, therapeutically equivalent) | April 19, 2019 | 1GM |
| SANDOZ INC | 202065 | AB (A-rated, therapeutically equivalent) | June 12, 2019 | 1GM |
| J MOLNER HOLDINGS INC | 208362 | AB (A-rated, therapeutically equivalent) | June 21, 2019 | 1GM |
| ZYDUS PHARMACEUTICALS USA INC | 208953 | AB (A-rated, therapeutically equivalent) | February 12, 2020 | 1GM |
| ANNORA PHARMA PRIVATE LTD | 213377 | AB (A-rated, therapeutically equivalent) | March 19, 2020 | 1GM |
| ACTAVIS MID ATLANTIC LLC | 205654 | AB (A-rated, therapeutically equivalent) | August 14, 2020 | 1GM |
| RISING PHARMA HOLDINGS INC | 219028 | AB (A-rated, therapeutically equivalent) | April 14, 2025 | 1GM |
Canasa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8217083 | June 6, 2028 | Drug product | None | 021252 |
| 8436051 | June 6, 2028 | Drug product | None | 021252 |
Canasa NDC codes
Questions
Is there a generic for Canasa?
Yes. The generic name for Canasa is mesalamine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Canasa products the Orange Book lists.
What is the generic name for Canasa?
The active ingredient in Canasa is mesalamine, per the FDA Orange Book.
When does the Canasa patent expire?
The last patent listed for Canasa in the Orange Book expires June 6, 2028. 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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