Drug

Olopatadine

As of the edition of 20 October 2026, Olopatadine is a small molecule: marketed, first approved in 1996 (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 2021
Kind
Small molecule
Brand name
Pataday Twice Daily Relief
First approved
18 December 1996 (US)
Approvals on record
13 in 6 regions
Holder of the most recent approval
Glenmark Specialty; 7 holders in all
Registered trials
33, 2 stopped early
Disease areas
Immune system; Eye; Ear, nose and throat; Lungs and airways; Infections; Injuries

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.

Target

GeneProteinUniProt
HRH1Histamine H1 receptorP35367

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1100
Phase 11100
Phase 23201
Phase 3111100
Phase 4171601
All trials33

Who has held its approvals

CompanyRoleYears
AlconOriginator and Lead sponsor of trials1996 to now
NovartisApplicant1997 to now