Rifamycin
As of the edition of 20 October 2026, Rifamycin is a small molecule: marketed, first approved in 1985 (FR); US protection ends in 2028.
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
- Aemcolo
- First approved
- 3 June 1985 (FR)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Adalvo Competence Center S.R.L.; 3 holders in all
- Registered trials
- 6, 0 stopped early
- Disease areas
- Digestive system; Nervous system; Nutrition and metabolism
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Cosmo Technologies.
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 product2 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 2 | 4 | 1 | 0 | 0 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Cosmo Technologies | Originator and Lead sponsor of trials | 2010 to now |