Treats travelers’ diarrhea (TD) caused by noninvasive strains of Escherichia coli. Sold as Xifaxan. Every FDA application for this active ingredient: 2 branded and 8 generic.
As of Nov 15, 2026, FDA lists 10 applications for Rifaximin (sold as Xifaxan), first approved May 25, 2004, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Xifaxan | Part D | $1.37B | +18% | 118,572 |
| Rifaximin for Prevention of Recurrent Mild-to-moderate Ascending Cholangitis After Biliary-enteric AnastomosisCholangitis, Ascending Cholangitis · Ruijin Hospital | Phase 4 | Not yet recruiting | Oct 26, 2026 |
| SIMBA in Irritable Bowel Syndrome (IBS)Irritable Bowel Syndrome (IBS), Microbiome · University of Calgary | Phase 1 | Not yet recruiting | Oct 20, 2026 |
| Comparison of the Efficacy of Saccharomyces Boulardii and Rifaximin in the Treatment of Small Intestinal Bacterial OvergrowthSmall Intestinal Bacterial Overgrowth Syndrome (SIBO) · Shandong University | Phase 4 | Not yet recruiting | Sep 11, 2026 |
| Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS SurgeryHepatic Encephalopathy, Fecal Microbiota Transplantation · Air Force Military Medical University, China | Early phase 1 | Recruiting | Jul 6, 2026 |
| Efficacy of Pregabalin for Patients With Irritable Bowel SyndromeIrritable Bowel Syndrome (IBS) · Beijing Tiantan Hospital | Not applicable | Recruiting | Jun 9, 2026 |
| Microbiota trAnSplant ThERaPy In hEpatiC Encephalopathy (MASTERPIECE)Hepatic Encephalopathy, Cirrhosis · VA Office of Research and Development | Phase 2 | Not yet recruiting | Apr 14, 2026 |
| Rifaximin Treatment in Bloating Predominant Functional Bowel DisordersBloating, Rifaximin · Mahidol University | Phase 3 | Not yet recruiting | Apr 13, 2026 |
| Evaluation of the Outcome of Fecal Microbiota TransplantationHepatic Encephalopathy, Fecal Microbiota Transplantation · Air Force Military Medical University, China | Phase 1 / Phase 2 | Not yet recruiting | Mar 6, 2026 |
| May 25, 2004 | XifaxanNDA 21361 · New molecular entity | Salix Pharms | 13 | Marketed |
| Mar 24, 2010 | XifaxanNDA 22554 · TYPE 6 | Salix Pharms | 0 | Marketed |
| Mar 19, 2026 | RifaximinANDA 208959 | Actavis Labs Fl Inc | 0 | Marketed |
| — | RifaximinANDA 213713 | Sandoz Inc | 0 | Discontinued |
| — | RifaximinANDA 214369 | Norwich Pharmaceuticals Inc | 0 | Discontinued |
| — | RifaximinANDA 214370 | Norwich | 0 | Discontinued |
| — | RifaximinANDA 218650 | Zydus Pharms USA Inc | 0 | Discontinued |
| — | RifaximinANDA 219570 | Cipla Ltd | 0 | Discontinued |
| — | RifaximinANDA 219687 | Mylan Pharmaceuticals Inc | 0 | Discontinued |
| — | RifaximinANDA 220451 | Alkem Laboratories Limited | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Zydus Pharms USA Inc
Mylan Pharmaceuticals Inc