Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
COLCHICINE | N022351 | AR HOLDING CO 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 | — |
Takeda Pharmaceuticals U.S.A. Inc. v. Par Pharmaceutical Inc. 12 patentsANDA 20-3976Colchicine | D. Del. | 2012-04-04 | Terminated 2014-09-22 | — |
| D.N.J. | 2011-04-21 | Terminated 2011-05-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.