Lopinavir
As of the edition of 20 October 2026, Lopinavir is a small molecule: marketed, first approved in 2000 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Small molecule
- Brand name
- Kaletra
- First approved
- 15 September 2000 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- AbbVie; 3 holders in all
- Registered trials
- 181, 27 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Lungs and airways; Digestive system; Nutrition and metabolism
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 41 | 28 | 0 | 7 |
| Phase 1 | 21 | 18 | 1 | 1 |
| Phase 2 | 40 | 30 | 2 | 6 |
| Phase 3 | 42 | 32 | 2 | 4 |
| Phase 4 | 37 | 23 | 0 | 9 |
| All trials | 181 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant and Lead sponsor of trials | 2000 to now |