Rilpivirine
As of the edition of 20 October 2026, Rilpivirine is a small molecule: marketed, first approved in 2011 (US); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Edurant
- First approved
- 20 May 2011 (US)
- Approvals on record
- 24 in 6 regions
- Holder of the most recent approval
- Johnson & Johnson; 12 holders in all
- Registered trials
- 86, 5 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Digestive system; Blood and lymph; Cancer
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. 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 product4 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 | 6 | 7 | 0 |
| Phase 1 | 27 | 26 | 0 | 1 |
| Phase 2 | 13 | 5 | 4 | 2 |
| Phase 3 | 18 | 11 | 5 | 1 |
| Phase 4 | 12 | 8 | 0 | 1 |
| All trials | 86 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant, Later holder and Lead sponsor of trials | 2005 to now |
| Gilead Sciences | Applicant and Later holder | 2011 to now |
| GSK | Later holder and Lead sponsor of trials | 2011 to now |