COLCHICINE | N022352 | TAKEDA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Takeda Pharmaceuticals U.S.A., Inc. et al v. Macleods Pharma USA, Inc. 13 patentsANDA 210633colchicine | D. Del. | 2026-01-14 | Active | — |
Takeda Pharmaceuticals USA Inc. v. Amneal Pharmaceuticals LLC 5 patentsANDA 204711colchicine | D. Del. | 2013-10-21 | Terminated 2016-05-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Par Pharmaceutical FDA-2012-P-0632 Par Pharmaceutical submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the Commissioner determine that Colchicine Tablets in strengths of 0.3 mg, 1.2 mg, and 1.8 mg are suitable for submission as an ANDA, with Colcrys Tablets 0.6 mg | Other | 2012-06-15 | Partially Denied | Par Pharmaceutical |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7601758 | Feb 10, 2029 | — | — | — | — | |
| 7619004 | Dec 3, 2028 | — | — | — | — | |
| 7820681 | Feb 17, 2029 | — | — | — | — | |
| 7906519 | Feb 17, 2029 | — | — | — | — | |
| 7915269 | Feb 17, 2029 | — | — | — | — | |
| 7935731 | Dec 3, 2028 | — | — | — | — | |
| 7964647 | Oct 6, 2028 | — | — | — | — | |
| 7964648 | Oct 6, 2028 | — | — | — | — | |
| 7981938 | Oct 6, 2028 | — | — | — | — | |
| 8093296 | Oct 6, 2028 | — | — | — | — | |
| 8093297 | Oct 6, 2028 | — | — | — | — | |
| 8093298 | Oct 6, 2028 | — | — | — | — | |
| 8097655 | Oct 6, 2028 | — | — | — | — | |
| 8415395 | Oct 6, 2028 | — | — | — | — | |
| 8415396 | Oct 6, 2028 | — | — | — | — | |
| 8440721 | Feb 17, 2029 | — | — | — | — | |
| 8440722 | Feb 17, 2029 | — | — | — | — |