Darunavir
As of the edition of 20 October 2026, Darunavir is a small molecule: marketed, first approved in 2006 (US); US protection ends in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Prezista
- First approved
- 23 June 2006 (US)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- Johnson & Johnson; 5 holders in all
- Withdrawn from market
- 22 January 2023 (in some regions)
- Registered trials
- 147, 15 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Digestive system; Nutrition and metabolism; Lungs and airways
US protection
US protection ends in 2026.
The last listed US drug-substance patent ends in 2026. 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 product7 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 | 16 | 14 | 0 | 1 |
| Phase 1 | 41 | 39 | 0 | 2 |
| Phase 2 | 24 | 20 | 0 | 2 |
| Phase 3 | 31 | 23 | 2 | 4 |
| Phase 4 | 35 | 21 | 2 | 6 |
| All trials | 147 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2001 to now |