Fidaxomicin
As of the edition of 20 October 2026, Fidaxomicin is a small molecule: marketed, first approved in 2011 (US); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Dificid
- First approved
- 27 May 2011 (US)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- SUN Pharmaceutical Industries; 4 holders in all
- Registered trials
- 21, 8 stopped early
- Disease areas
- Infections; Digestive system; Injuries; Nervous system
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 Merck & Co..
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 product5 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 5 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 1 | 1 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 3 | 2 | 0 | 1 |
| Phase 3 | 6 | 4 | 1 | 1 |
| Phase 4 | 7 | 2 | 0 | 5 |
| All trials | 21 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Acquired holder and Lead sponsor of trials | 2004 to now |
| Tillotts Pharma | Applicant | 2011 to now |
| Astellas | Applicant and Lead sponsor of trials | 2012 to now |