FDA Orange Book · active-ingredient family
Colchicine
Colchicine is approved as 4 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LODOCO · NDA 215727
4
Brand (NDA)
17
Generics (ANDA)
41
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LODOCORLD | AGEPHA PHARMA FZ | NDA 215727 | — | Jun 16, 2023 | |
| GLOPERBARLD | SCILEX PHARMS | NDA 210942 | — | Jan 30, 2019 | |
| MITIGARERLD | HIKMA INTL PHARMS | NDA 204820 | AB | Sep 26, 2014 | |
| COLCRYSRLD | TAKEDA PHARMS USA | NDA 022352 | — | Jul 29, 2009 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLCHICINE | MICRO LABS | ANDA 212880 | AB | Feb 17, 2026 | |
| COLCHICINE | MACLEODS PHARMS LTD | ANDA 210633 | AB | Feb 13, 2026 | |
| COLCHICINE | ANNORA PHARMA | ANDA 217620 | AB | Apr 29, 2024 | |
| COLCHICINE | AUROBINDO PHARMA LTD | ANDA 215463 | AB | Apr 29, 2024 | |
| COLCHICINE | GRANULES | ANDA 210757 | AB | Apr 29, 2024 | |
| COLCHICINE | STRIDES PHARMA | ANDA 209173 | AB | Mar 10, 2022 | |
| COLCHICINE | AUROBINDO PHARMA LTD | ANDA 215444 | AB | Jan 06, 2022 | |
| COLCHICINE | HETERO LABS LTD V | ANDA 208993 | AB | Aug 13, 2021 | |
| COLCHICINE | PH HEALTH | ANDA 203976 | AB | Aug 12, 2021 | |
| COLCHICINE | GRANULES | ANDA 210425 | AB | Feb 05, 2020 | |
| COLCHICINE×2 | ZYDUS PHARMS | ANDA 211519 | — | Nov 14, 2019 | |
| COLCHICINE | MYLAN | ANDA 209470 | AB | Sep 16, 2019 | |
| COLCHICINE | DR REDDYS | ANDA 209876 | AB | Sep 06, 2019 | |
| COLCHICINE | WATSON LABS INC | ANDA 204461 | AB | Jul 31, 2019 | |
| COLCHICINE | ALKEM LABS LTD | ANDA 211250 | AB | Feb 08, 2019 | |
| COLCHICINE | PH HEALTH | ANDA 208678 | AB | Nov 29, 2018 | |
| COLCHICINE | AMNEAL PHARMS | ANDA 204711 | AB | Sep 28, 2016 |
Listed patents (41)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7964647 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 8093297 | Oct 06, 2028 | in 2 yr 4 mo | U-1161 |
| 8097655 | Oct 06, 2028 | in 2 yr 4 mo | U-1020 |
| 8415396 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 8093296 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 8093298 | Oct 06, 2028 | in 2 yr 4 mo | U-1116 |
| 8415395 | Oct 06, 2028 | in 2 yr 4 mo | U-1007 |
| 7981938 | Oct 06, 2028 | in 2 yr 4 mo | U-1166 |
| 7964648 | Oct 06, 2028 | in 2 yr 4 mo | U-1161 |
| 7619004 | Dec 03, 2028 | in 2 yr 6 mo | U-1020 |
| 7935731 | Dec 03, 2028 | in 2 yr 6 mo | U-1116 |
| 7601758 | Feb 10, 2029 | in 2 yr 8 mo | U-1007 |
| 7820681 | Feb 17, 2029 | in 2 yr 8 mo | U-1020 |
| 7915269 | Feb 17, 2029 | in 2 yr 8 mo | U-1007 |
| 8440722 | Feb 17, 2029 | in 2 yr 8 mo | U-1020 |
| 7906519 | Feb 17, 2029 | in 2 yr 8 mo | U-1116 |
| 8440721 | Feb 17, 2029 | in 2 yr 8 mo | U-1007 |
| 9555029 | Aug 22, 2033 | in 7 yr 3 mo | U-1020 |
| 9789108 | Aug 22, 2033 | in 7 yr 3 mo | U-1020 |
| 9675613 | Aug 22, 2033 | in 7 yr 3 mo | U-1020 |
| 8927607 | Aug 22, 2033 | in 7 yr 3 mo | U-1020 |
| 9399036 | Aug 22, 2033 | in 7 yr 3 mo | U-1020 |
| 12364675 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 12233035 | Nov 01, 2033 | in 7 yr 6 mo | U-4132 |
| 11026901 | Nov 01, 2033 | in 7 yr 6 mo | U-3638 |
| 11026900 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 11026899 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 10842762 | Nov 01, 2033 | in 7 yr 6 mo | U-3640 |
| 10265281 | Nov 01, 2033 | in 7 yr 6 mo | U-3639 |
| 10206891 | Nov 01, 2033 | in 7 yr 6 mo | U-3641 |
| 9744144 | Nov 01, 2033 | in 7 yr 6 mo | U-3643 |
| 11944594 | Nov 01, 2033 | in 7 yr 6 mo | U-3864 |
| 12280025 | Nov 01, 2033 | in 7 yr 6 mo | U-4168 |
| 11944595 | Nov 01, 2033 | in 7 yr 6 mo | U-3867 |
| 10130585 | May 09, 2034 | in 8 yr | U-3642 |
| 12274751 | Nov 22, 2036 | in 10 yr 7 mo | U-2814 |
| 12514819 | Nov 22, 2036 | in 10 yr 7 mo | U-2814 |
| 10383820 | Nov 22, 2036 | in 10 yr 7 mo | ProductU-2814 |
| 10383821 | Nov 22, 2036 | in 10 yr 7 mo | Product |
| 9907751 | Nov 22, 2036 | in 10 yr 7 mo | Product |
| 10226423 | Dec 20, 2037 | in 11 yr 8 mo | Product |
Colchicine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
