Simeprevir
As of the edition of 20 October 2026, Simeprevir is a small molecule: marketed, first approved in 2013 (JP); US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Olysio
- First approved
- 27 September 2013 (JP)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Johnson & Johnson; 2 holders in all
- Withdrawn from market
- 1 May 2018 (in some regions)
- Registered trials
- 83, 6 stopped early
- Disease areas
- Digestive system; Infections; Urinary and reproductive; Cancer; Immune system; Pregnancy and women's health
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Johnson & Johnson.
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 product6 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 | 5 | 3 | 0 | 1 |
| Phase 1 | 35 | 34 | 0 | 1 |
| Phase 2 | 21 | 20 | 0 | 1 |
| Phase 3 | 18 | 17 | 0 | 1 |
| Phase 4 | 4 | 2 | 0 | 2 |
| All trials | 83 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2007 to now |