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.
OBETICHOLIC ACID | A214935 | OPTIMUS PHARMA PRIVATE LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Intercept Pharmaceuticals, Inc. et al v. Optimus Pharma Pvt. Ltd. et al 7 patentsANDA 214935obeticholic acid | D. Del. | 2020-09-11 | Terminated 2023-01-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.