Sofosbuvir
As of the edition of 20 October 2026, Sofosbuvir is a small molecule: marketed, first approved in 2013 (US); US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Sovaldi
- First approved
- 6 December 2013 (US)
- Approvals on record
- 25 in 4 regions
- Holder of the most recent approval
- Gilead Sciences; 5 holders in all
- Registered trials
- 291, 22 stopped early
- Disease areas
- Digestive system; Infections; Immune system; Urinary and reproductive; Lungs and airways; Blood and lymph
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Gilead Sciences.
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 product106 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 106 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 47 | 19 | 2 | 6 |
| Phase 1 | 10 | 8 | 2 | 0 |
| Phase 2 | 92 | 84 | 2 | 4 |
| Phase 3 | 82 | 66 | 0 | 3 |
| Phase 4 | 60 | 33 | 6 | 9 |
| All trials | 291 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Originator, Applicant and Lead sponsor of trials | 2013 to now |