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.
LINAGLIPTIN;METFORMIN HYDROCHLORIDE | A208430 | MYLAN PHARMS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Mylan Pharmaceuticals Inc. et al 1 patentANDA 208431, 208430linagliptin | WVND | 2024-08-29 | Terminated 2025-11-24 | — |
Boehringer Ingelheim Pharmaceuticals, Inc. et al v. Mylan Pharmaceuticals Inc. et al 3 patentsANDA 208431, 208430linagliptin | WVND | 2015-08-25 | Terminated 2016-07-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.