FDA Orange Book
Generic for Colcrys
Colcrys 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 Colcrys is colchicine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Colcrys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.6MG | Discontinued | None | 12 | AB |
NDA 022352, held by TAKEDA 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 |
|---|---|---|---|---|
| AMNEAL PHARMACEUTICALS | 204711 | AB (A-rated, therapeutically equivalent) | September 28, 2016 | 0.6MG |
| ALKEM LABORATORIES LTD | 211250 | AB (A-rated, therapeutically equivalent) | February 8, 2019 | 0.6MG |
| ZYDUS PHARMACEUTICALS USA INC | 211519 | AB (A-rated, therapeutically equivalent) | February 19, 2019 | 0.6MG |
| WATSON LABORATORIES INC | 204461 | AB (A-rated, therapeutically equivalent) | July 31, 2019 | 0.6MG |
| DR REDDYS LABORATORIES LTD | 209876 | AB (A-rated, therapeutically equivalent) | September 6, 2019 | 0.6MG |
| MYLAN PHARMACEUTICALS INC | 209470 | AB (A-rated, therapeutically equivalent) | September 16, 2019 | 0.6MG |
| GRANULES PHARMACEUTICALS INC | 210425 | AB (A-rated, therapeutically equivalent) | February 5, 2020 | 0.6MG |
| PH HEALTH LTD | 203976 | AB (A-rated, therapeutically equivalent) | August 12, 2021 | 0.6MG |
| HETERO LABS LTD UNIT V | 208993 | AB (A-rated, therapeutically equivalent) | August 13, 2021 | 0.6MG |
| AUROBINDO PHARMA LTD | 215444 | AB (A-rated, therapeutically equivalent) | January 6, 2022 | 0.6MG |
| STRIDES PHARMA GLOBAL PTE LTD | 209173 | AB (A-rated, therapeutically equivalent) | March 10, 2022 | 0.6MG |
| MACLEODS PHARMACEUTICALS LTD | 210633 | AB (A-rated, therapeutically equivalent) | February 13, 2026 | 0.6MG |
Colcrys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7964647 | October 6, 2028 | Method of use | U-1007 | 022352 |
| 8093297 | October 6, 2028 | Method of use | U-1161 | 022352 |
| 8097655 | October 6, 2028 | Method of use | U-1020 | 022352 |
| 8415396 | October 6, 2028 | Method of use | U-1007 | 022352 |
| 8093296 | October 6, 2028 | Method of use | U-1007 | 022352 |
| 8093298 | October 6, 2028 | Method of use | U-1116 | 022352 |
| 8415395 | October 6, 2028 | Method of use | U-1007 | 022352 |
| 7981938 | October 6, 2028 | Method of use | U-1166 | 022352 |
| 7964648 | October 6, 2028 | Method of use | U-1161 | 022352 |
| 7619004 | December 3, 2028 | Method of use | U-1020 | 022352 |
| 7935731 | December 3, 2028 | Method of use | U-1116 | 022352 |
| 7601758 | February 10, 2029 | Method of use | U-1007 | 022352 |
| 7820681 | February 17, 2029 | Method of use | U-1020 | 022352 |
| 7915269 | February 17, 2029 | Method of use | U-1007 | 022352 |
| 8440722 | February 17, 2029 | Method of use | U-1020 | 022352 |
| 7906519 | February 17, 2029 | Method of use | U-1116 | 022352 |
| 8440721 | February 17, 2029 | Method of use | U-1007 | 022352 |
Colcrys NDC codes
Questions
Is there a generic for Colcrys?
Yes. The generic name for Colcrys is colchicine. 12 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 Colcrys?
The active ingredient in Colcrys is colchicine, per the FDA Orange Book.
When does the Colcrys patent expire?
The last patent listed for Colcrys in the Orange Book expires February 17, 2029. 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.