FDA Orange Book
Generic for Colazal
Colazal contains balsalazide. 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 Colazal is balsalazide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Colazal and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Colazal products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 750MG | Marketed (Rx) | AB | 5 | AB |
NDA 020610, held by VALEANT PHARMACEUTICALS INTERNATIONAL. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic balsalazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 077883 | AB (A-rated, therapeutically equivalent) | December 28, 2007 | 750MG |
| HIKMA PHARMACEUTICALS USA INC | 077806 | AB (A-rated, therapeutically equivalent) | December 28, 2007 | 750MG |
| NOVITIUM PHARMA LLC | 077807 | AB (A-rated, therapeutically equivalent) | December 28, 2007 | 750MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 217592 | AB (A-rated, therapeutically equivalent) | June 8, 2023 | 750MG |
| CARNEGIE PHARMACEUTICALS LLC | 219422 | AB (A-rated, therapeutically equivalent) | April 3, 2025 | 750MG |
Colazal patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7625884 | August 24, 2026 | Method of use | U-141 | 020610 |
| 7452872 | August 24, 2026 | Method of use | U-141 | 020610 |
| 7452872*PED | February 24, 2027 | Method of use | None | 020610 |
| 7625884*PED | February 24, 2027 | Method of use | None | 020610 |
Questions
Is there a generic for Colazal?
Yes. The generic name for Colazal is balsalazide. 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 Colazal?
The active ingredient in Colazal is balsalazide, per the FDA Orange Book.
When does the Colazal patent expire?
The last patent listed for Colazal in the Orange Book expires February 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.