Daclatasvir
As of the edition of 20 October 2026, Daclatasvir is a small molecule: marketed, first approved in 2015 (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
- Daklinza
- First approved
- 24 July 2015 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Bristol Myers Squibb
- Withdrawn from market
- 26 August 2019 (in some regions)
- Registered trials
- 111, 9 stopped early
- Disease areas
- Digestive system; Infections; Lungs and airways; Nutrition and metabolism; Urinary and reproductive; Pregnancy and women's 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 Bristol Myers Squibb.
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 product14 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 14 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 20 | 5 | 1 | 1 |
| Phase 1 | 14 | 14 | 0 | 0 |
| Phase 2 | 32 | 26 | 0 | 6 |
| Phase 3 | 36 | 27 | 0 | 2 |
| Phase 4 | 9 | 9 | 0 | 0 |
| All trials | 111 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 2014 to now |