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.
METFORMIN HYDROCHLORIDE || SITAGLIPTIN | A212338 | MACLEODS PHARMS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation 2 patentsANDA 211073, 212338sitagliptin phosphate; metformin hydrochloride; sitagliptin phosphate | D. Del. | 2019-08-08 | Terminated 2023-02-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.