RIFAXIMIN | N021361 | SALIX PHARMACEUTICALS INC
| 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 | N.D. W. Va. | 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. NORWICH PHARMACEUTICALS, INC. et al 2 patentsANDA 214370rifaximin | D.N.J. | 2024-06-20 | Active | — |
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 | — | |
Salix Pharmaceuticals Ltd. et al v. Sun Pharmaceuticals Industries Ltd. 14 patentsANDA 213042rifaximin | D. Del. | 2019-04-24 | Terminated 2020-09-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BakerHostetler LLP (on behalf of Salix Pharmaceuticals ... FDA-2021-P-0096 · 30 docket documents Salix Pharmaceuticals, Inc., through counsel at BakerHostetler LLP, filed a citizen petition on December 28, 2020, requesting that the FDA refrain from approving any abbreviated new drug application under section 505(j) for generic versions of Xifaxan (rifaximin) unless approval incorporates specifi | 505(q) | 2021-02-03 | Partially Denied | Salix Pharmaceuticals Inc |
Strides Arcolab Ltd - Citizen Petition FDA-2008-P-0404 · 3 docket documents Strides Arcolab Ltd filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Rifaximin Capsules, 200 mg suitable for an abbreviated new drug application (ANDA), with the reference-listed drug being Xifaxan Tablets, 200 mg | Other | 2008-07-16 | Denied | — |
Salix Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0300 · 4 docket documents Salix Pharmaceuticals, Inc., holder of NDA #21-361 for Xifaxan (rifaximin) Tablets, 200 mg, filed this citizen petition on May 14, 2008, requesting that the FDA refuse to receive or approve any ANDA referencing Xifaxan without scientifically appropriate bioequivalence data, including clinical endpoi | 505(q) | 2008-05-21 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.