Raltegravir
As of the edition of 20 October 2026, Raltegravir is a small molecule: marketed, first approved in 2007 (US); US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Isentress
- First approved
- 12 October 2007 (US)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Merck & Co.; 2 holders in all
- Withdrawn from market
- 24 April 2017 (in some regions)
- Registered trials
- 181, 21 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Digestive system; Nutrition and metabolism; Nervous system
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. 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 product9 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 | 35 | 26 | 0 | 3 |
| Phase 1 | 33 | 31 | 0 | 0 |
| Phase 2 | 33 | 26 | 1 | 6 |
| Phase 3 | 33 | 27 | 0 | 6 |
| Phase 4 | 47 | 30 | 0 | 6 |
| All trials | 181 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant and Lead sponsor of trials | 2007 to now |