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.
REVEFENACIN | A218089 | MANKIND PHARMA LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
THERAVANCE BIOPHARMA R&D IP, LLC et al v. EUGIA PHARMA SPECIALITIES LTD. et al 13 patentsANDA 218128, 218089, 217958revefenacin | D.N.J. | 2025-05-02 | Terminated 2025-06-06 | — |
THERAVANCE BIOPHARMA R&D IP, LLC et al v. EUGIA PHARMA SPECIALTIES LTD. et al 12 patentsANDA 218089, 218100, 218128, 218088, 217868, 217958revefenacin | D.N.J. | 2023-02-16 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.