Gepotidacin
As of the edition of 20 October 2026, Gepotidacin is a small molecule: marketed, first approved in 2025 (US); US protection ends in 2042.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Blujepa
- First approved
- 25 March 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- GSK
- Registered trials
- 23, 0 stopped early
- Disease areas
- Infections; Urinary and reproductive; Pregnancy and women's health; Lungs and airways
US protection
US protection ends in 2042.
The last listed US drug-substance patent ends in 2042. The application that gives this date is held by GSK.
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 product6 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 1 | 15 | 13 | 2 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 5 | 5 | 0 | 0 |
| All trials | 23 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 2011 to now |