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.
SITAGLIPTIN PHOSPHATE | A202473 | MYLAN PHARMS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Merck Sharp & Dohme, LLC v. Mylan Pharmaceuticals Inc. et al 2 patentsANDA 202473, 202478sitagliptin phosphate; metformin hydrochloride; sitagliptin phosphate | WVND | 2019-05-02 | Terminated 2023-05-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.