Bepotastine
As of the edition of 20 October 2026, Bepotastine is a small molecule: marketed, first approved in 2009 (US); acts on HRH1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Bepreve
- First approved
- 8 September 2009 (US)
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Bausch Health; 2 holders in all
- Registered trials
- 19, 0 stopped early
- Disease areas
- Immune system; Ear, nose and throat; Lungs and airways; Eye; Skin and connective tissue
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.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Bepotastine.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| HRH1 | Histamine H1 receptor | P35367 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bausch Health | Acquired holder and Lead sponsor of trials | 2007 to now |
| Mitsubishi Tanabe Pharma | Applicant |