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.
RIFAXIMIN | N022554 | SALIX PHARMS
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
SALIX PHARMACEUTICALS, INC. et al v. AJANTA PHARMA LTD. et al 3 patentsANDA 220990rifaximin | D.N.J. | 2025-11-20 | Terminated 2026-01-13 | — |
SALIX PHARMACEUTICALS, INC. et al v. ALKEM LABORATORIES LTD. 3 patentsANDA 220451rifaximin | D.N.J. | 2025-06-10 | Terminated 2025-08-14 | — |
SALIX PHARMACEUTICALS, INC. et al v. SABA ILAC SANAYI VE TICARET A.S. 4 patentsANDA 219940rifaximin | D.N.J. | 2025-04-04 | Terminated 2025-09-15 | — |
Salix Pharmaceuticals, Inc. et al v. Mylan Pharmaceuticals, Inc. 3 patentsANDA 219687rifaximin | WVND | 2025-03-26 | Terminated 2025-10-02 | — |
SALIX PHARMACEUTICALS, INC. et al v. CIPLA USA, INC. et al 3 patentsANDA 219570rifaximin | D.N.J. | 2024-11-01 | Terminated 2025-10-21 | — |
SALIX PHARMACEUTICALS, INC. et al v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC et al 8 patentsANDA 218862rifaximin | D.N.J. | 2024-04-05 | Active | — |
Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. 23 patentsANDA 214369rifaximin | D. Del. | 2020-03-26 | Terminated 2022-08-10 | — |
| D.N.J. | 2019-09-30 | Terminated 2020-05-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.