Lamivudine
As of the edition of 20 October 2026, Lamivudine is a small molecule: marketed, first approved in 1995 (US); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Epivir
- First approved
- 17 November 1995 (US)
- Approvals on record
- 50 in 6 regions
- Holder of the most recent approval
- Pharmobedient Consulting; 13 holders in all
- Withdrawn from market
- 24 April 2017 (in some regions)
- Registered trials
- 405, 31 stopped early
- Disease areas
- Infections; Immune system; Urinary and reproductive; Digestive system; Nutrition and metabolism; Cancer
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Merck & Co. holds a later exclusivity on its own new formulation or combination product, ending 2029; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 66 | 52 | 2 | 7 |
| Phase 1 | 41 | 37 | 2 | 1 |
| Phase 2 | 98 | 74 | 8 | 8 |
| Phase 3 | 110 | 85 | 7 | 8 |
| Phase 4 | 90 | 62 | 6 | 7 |
| All trials | 405 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator, Applicant, Later holder and Lead sponsor of trials | 1995 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2005 to now |