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 AND METFORMIN HYDROCHLORIDE | A214859 | AUROBINDO PHARMA LIMITED
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Merck Sharp & Dohme Corp. v. Aurobindo Pharma, Ltd. et al 1 patentANDA 214859metformin hydrochloride; sitagliptin phosphate | D. Del. | 2020-08-21 | Terminated 2021-09-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.