Elbasvir
As of the edition of 20 October 2026, Elbasvir is a small molecule: marketed, first approved in 2016 (US); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Zepatier
- First approved
- 28 January 2016 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Merck & Co.
- Registered trials
- 62, 10 stopped early
- Disease areas
- Digestive system; Infections; Urinary and reproductive; Pregnancy and women's health; Chemically induced; Mental health
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. 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 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 not stated | 9 | 5 | 0 | 0 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 15 | 15 | 0 | 0 |
| Phase 3 | 17 | 13 | 0 | 2 |
| Phase 4 | 18 | 8 | 0 | 8 |
| All trials | 62 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 2012 to now |