FDA Orange Book
Generic for Mitigare
Mitigare contains colchicine. 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 Mitigare is colchicine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mitigare products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.6MG | Marketed (Rx) | AB | 5 | AB |
NDA 204820, held by HIKMA 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 colchicine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PH HEALTH LTD | 208678 | AB (A-rated, therapeutically equivalent) | November 29, 2018 | 0.6MG |
| ANNORA PHARMA PRIVATE LTD | 217620 | AB (A-rated, therapeutically equivalent) | April 29, 2024 | 0.6MG |
| AUROBINDO PHARMA LTD | 215463 | AB (A-rated, therapeutically equivalent) | April 29, 2024 | 0.6MG |
| GRANULES PHARMACEUTICALS INC | 210757 | AB (A-rated, therapeutically equivalent) | April 29, 2024 | 0.6MG |
| MICRO LABS LTD | 212880 | AB (A-rated, therapeutically equivalent) | February 17, 2026 | 0.6MG |
Mitigare patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9555029 | August 22, 2033 | Method of use | U-1020 | 204820 |
| 9789108 | August 22, 2033 | Method of use | U-1020 | 204820 |
| 9675613 | August 22, 2033 | Method of use | U-1020 | 204820 |
| 8927607 | August 22, 2033 | Method of use | U-1020 | 204820 |
| 9399036 | August 22, 2033 | Method of use | U-1020 | 204820 |
Mitigare NDC codes
Questions
Is there a generic for Mitigare?
Yes. The generic name for Mitigare is colchicine. 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 Mitigare?
The active ingredient in Mitigare is colchicine, per the FDA Orange Book.
When does the Mitigare patent expire?
The last patent listed for Mitigare in the Orange Book expires August 22, 2033. 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.