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.
DABIGATRAN ETEXILATE MESYLATE | A208057 | TEVA PHARMS USA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Boehringer Ingelheim Pharma GmbH & Co. KG et al v. Teva Pharmaceuticals USA Inc. et al 1 patentANDA 208057dabigatran etexilate mesylate | D. Del. | 2015-01-16 | Terminated 2015-04-22 | — |
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG et al v. TEVA PHARMACEUTICALS USA, INC. et al 1 patentANDA 208057, 208040, 208067dabigatran etexilate mesylate | D.N.J. | 2014-12-15 | Terminated 2018-01-26 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.