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 AND METFORMIN HYDROCHLORIDE | A208454 | SUN PHARM INDS LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD et al 1 patentANDA 208455, 208454linagliptin; linagliptin and metformin hydrochloride | D.N.J. | 2016-03-29 | Terminated 2016-04-19 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.