Ledipasvir
As of the edition of 20 October 2026, Ledipasvir is a small molecule: marketed, first approved in 2014 (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
- Harvoni
- First approved
- 10 October 2014 (US)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- Gilead Sciences; 2 holders in all
- Registered trials
- 90, 9 stopped early
- Disease areas
- Digestive system; Infections; Blood and lymph; Immune system; Inherited and neonatal; Urinary and reproductive
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 product47 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 47 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 16 | 9 | 0 | 2 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 34 | 31 | 0 | 2 |
| Phase 3 | 22 | 17 | 0 | 2 |
| Phase 4 | 16 | 10 | 0 | 3 |
| All trials | 90 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Applicant and Lead sponsor of trials | 2010 to now |