Latanoprost
As of the edition of 20 October 2026, Latanoprost is a small molecule: marketed, first approved in 1996 (US); acts on PTGFR; 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 2024
- Kind
- Small molecule
- Brand name
- Xalatan
- First approved
- 5 June 1996 (US)
- Approvals on record
- 18 in 7 regions
- Holder of the most recent approval
- União Química Farmacêutica Nacional S/A; 13 holders in all
- Registered trials
- 97, 8 stopped early
- Disease areas
- Eye; Heart and blood vessels; Skin and connective tissue; Hormones; Ear, nose and throat; Inherited and neonatal
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.
Alcon holds a later exclusivity on its own new formulation or combination product, ending 2034; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
5 companies on route B because of this drug.
Companies on route B for this drug
In the product5 companies are on route B because of Latanoprost.
See the 5 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PTGFR | Prostaglandin F2-alpha receptor | P43088 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 15 | 11 | 0 | 0 |
| Phase 1 | 7 | 5 | 1 | 0 |
| Phase 2 | 24 | 17 | 2 | 2 |
| Phase 3 | 20 | 17 | 0 | 3 |
| Phase 4 | 31 | 22 | 3 | 3 |
| All trials | 97 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 1992 to now |
| Santen | Applicant and Lead sponsor of trials | 2010 to now |
| Thea Pharma | Applicant | 2012 to now |
| Santen Pharmaceutical | Later holder and Lead sponsor of trials | 2016 to now |
| Otsuka | Later holder | 2016 to now |
| Viatris | Acquired holder | 2020 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2021 to now |
| Cristália Produtos Químicos Farmacêuticos Ltda | Applicant | 2024 to now |
| União Química Farmacêutica Nacional S/A | Later holder | 2024 to now |