Rifaximin
As of the edition of 20 October 2026, Rifaximin is a small molecule: marketed, first approved in 1999 (ES); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Xifaxan
- First approved
- 1 September 1999 (ES)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- BIOLAB SANUS FARMACĂUTICA LTDA; 5 holders in all
- Registered trials
- 142, 28 stopped early
- Disease areas
- Digestive system; Nervous system; Nutrition and metabolism; Infections; Blood and lymph; Urinary and reproductive
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Bausch Health.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product7 listings count towards this date. The exact date and each listing are in the product.
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Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 32 | 17 | 5 | 5 |
| Phase 1 | 12 | 7 | 3 | 1 |
| Phase 2 | 38 | 12 | 6 | 10 |
| Phase 3 | 34 | 18 | 3 | 6 |
| Phase 4 | 26 | 10 | 7 | 6 |
| All trials | 142 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Applicant and Lead sponsor of trials | 2004 to now |
| ASKA Pharmaceutical | Applicant | 2016 to now |