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.
DOXYCYCLINE | A203278 | AMNEAL PHARMS
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Galderma Laboratories, L.P. et al v. Amneal Pharmaceuticals, LLC et al 3 patentsANDA 203278doxycycline | D. Del. | 2019-03-01 | Terminated 2020-08-31 | — |
Galderma Laboratories L.P. et al v. Amneal Pharmaceuticals LLC et al 10 patentsANDA 203278doxycycline | D. Del. | 2016-03-31 | Terminated 2018-09-04 | — |
Galderma Laboratories Inc. et al v. Amneal Pharmaceuticals LLC et al 3 patentsANDA 203278doxycycline | D. Del. | 2011-11-08 | Terminated 2014-05-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.