olopatadine

Trade name: patanol

Small moleculeapproved

Approved

Dec 18, 1996

Olopatadine is an antihistamine (as well as anticholinergic and mast cell stabilizer) used to treat itching associated with allergic conjunctivitis (eye allergies). Olopatadine is a selective histamine H1 antagonist that binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. Olopatadine is devoid of effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Some known side effects include a headache (7% of occurrence), eye burning and/or stinging (5%), blurred vision, dry eyes, foreign body sensation, hyperemia, keratitis, eyelid edema, pruritus, asthenia, sore throat (pharyngitis), rhinitis, sinusitis, and taste perversion. — NCATS

Clinical trial activity

69 trials · 37 clinical orgs · 34 marketing orgs

Phase 1
3
Phase 2
36
Phase 3
29
Phase 4
26

Earliest trial started Sep 1, 2000 (NCT00609128)

Timeline

1990s

  1. Dec 18, 1996

    Novartis — Earliest FDA Approval

  2. Dec 18, 1996

    Novartis — NDA Secondary Org

  3. Dec 18, 1996

    Novartis — NDA Organization

  4. Dec 18, 1996

    Nestle — NDA Secondary Org

2000s

  1. Jan 1, 2006

    Alcon — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2008

    Alcon — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 28, 2010

    Sandoz — Marketing Organization

  2. Jan 28, 2010

    Novartis — Marketing Organization

  3. Jan 1, 2011

    Alcon — Earliest Phase 1 Sponsor(trial)

  4. Aug 27, 2014

    Actavis — Marketing Organization

  5. Oct 8, 2014

    Apotex — Marketing Organization

  6. Jan 30, 2015

    Alcon — Marketing Organization

  7. Feb 2, 2015

    Watson Pharmaceuticals — Marketing Organization

  8. Jul 13, 2015

    Barr Laboratories — Marketing Organization

  9. Jul 13, 2015

    Teva — Marketing Organization

  10. Dec 7, 2015

    Somerset Pharmaceuticals — Marketing Organization

  11. Dec 7, 2015

    USV — Marketing Organization

  12. Dec 7, 2015

    Zambon — Marketing Organization

  13. Dec 18, 2015

    Aurobindo Pharma — Marketing Organization

  14. Dec 18, 2015

    Eugia Pharma — Marketing Organization

  15. Jan 10, 2017

    Sciegen Pharmaceticals — Marketing Organization

  16. Jan 31, 2017

    Perrigo — Marketing Organization

  17. Jan 31, 2017

    Padagis Us — Marketing Organization

  18. Jun 28, 2017

    Wockhardt — Marketing Organization

  19. Jun 28, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  20. Jul 26, 2017

    Bausch Health Companies — Marketing Organization

  21. Jul 26, 2017

    Cipla — Marketing Organization

  22. Jul 26, 2017

    Bausch & Lomb — Marketing Organization

  23. Dec 5, 2017

    Akorn, Inc. — Marketing Organization

  24. Mar 21, 2018

    Mylan — Marketing Organization

  25. Mar 21, 2018

    Rising Pharmaceuticals — Marketing Organization

  26. Dec 7, 2018

    Alembic — Marketing Organization

  27. Aug 2, 2019

    Gland Pharma Ltd — Marketing Organization

  28. Aug 2, 2019

    Fosun — Marketing Organization

  29. Sep 26, 2019

    FDC — Marketing Organization

2020s

  1. Jan 28, 2020

    Amneal Pharmaceuticals — Marketing Organization

  2. Feb 19, 2020

    AbbVie — Marketing Organization

  3. Feb 19, 2020

    Lachman Consultants — Marketing Organization

  4. Jun 16, 2020

    Micro Labs Ltd India — Marketing Organization

  5. Aug 19, 2020

    Hikma — Marketing Organization

  6. Jan 13, 2022

    Glenmark Pharmaceuticals — NDA Secondary Org

Indications

Mechanism of action

Combination products

Approval history

  • approvedDec 18, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CC/C=C1/c2ccccc2COc2ccc(CC(=O)O)cc21
Mol. weight
337.42 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • ac 170
  • ac 170
  • ac-170
  • ac-170
  • al-4943a
  • al-4943a
  • alo-4943a
  • alo-4943a
  • kw-4679
  • kw-4679
  • olopatadin
  • olopatadin
  • olopatadina
  • olopatadina
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine
  • olopatadine hcl
  • olopatadine hcl
  • olopatadine hcl
  • olopatadine hydrochloride
  • olopatadine hydrochloride
  • olopatadine hydrochloride
  • olopatadine hydrochloride
  • olopatadine hydrochloride
  • olopatadinum
  • olopatadinum
  • opatanol
  • opatanol
  • opatanol
  • opatanol
  • pataday
  • pataday
  • pataday
  • patanase
  • patanase
  • patanol
  • patanol
  • patanol
  • patanol
  • t1210

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06126952Phase 2Oct 30, 2023Cliantha Research Limited, Meda Pharmaceuticals
NCT05314621Phase 4Dec 31, 2021Andover Research Eye Institute
NCT05265910Phase 4Dec 14, 2021Andover Research Eye Institute
NCT04776096Phase 4Mar 10, 2021Laboratorios Poen
NCT04708821Phase 4Feb 15, 2021Florida Clinical Research Center, LLC, Ocular Therapeutix, Inc.
NCT03463031Phase 3Mar 16, 2018Glenmark Pharmaceuticals
NCT03320434Phase 2Oct 13, 2017ORA, Inc.
NCT02870205Phase 3Aug 1, 2016Glenmark Pharmaceuticals
NCT02709538Phase 3Apr 1, 2016Glenmark Pharmaceuticals
NCT02756624Phase 3Apr 1, 2016NicOx, ORA, Inc.
NCT02631551Phase 3Mar 1, 2016Glenmark Pharmaceuticals
NCT02478398Phase 3Jul 20, 2015Merck
NCT02322216Phase 3Dec 1, 2014Alcon
NCT02318303Phase 2Dec 1, 2014Glenmark Pharmaceuticals
NCT01657240Phase 3Nov 1, 2014Laboratorios Sophia S.A de C.V.
NCT02161146Phase 3Jun 1, 2014Allergan
NCT02173249Phase 1Jun 1, 2014Aciex Therapeutics, Inc.
NCT02132169Phase 3May 1, 2014Aciex Therapeutics, Inc.
NCT03444506Phase 2Jan 27, 2014Glenmark Pharmaceuticals
NCT02251613Phase 4Dec 1, 2013Alcon
Showing 20 of 69 trials
Page 1 / 4

Organizations

Research & Development (37)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AlconFor profit262642006
Aciex Therapeutics, Inc.For profit7722011
Glenmark PharmaceuticalsFor profit6622014
ORA, Inc.For profit5232008
AllerganFor profit4422010
MerckFor profit4322007
ALK-Abello, S.A.For profit2212007
Andover Research Eye InstituteAcademic/Hospital2212021
Santen Inc.For profit2212011
Bausch & LombFor profit1112010
Central Texas Allergy and AsthmaAcademic/Hospital1012008
Cliantha Research LimitedFor profit1012023
Florida Clinical Research Center, LLCFor profit1112021
GlaxoSmithKlineFor profit1012009
Gulf Coast Research Associates, IncFor profit1012008
Harvard UniversityAcademic/Hospital1112008
Hom, Milton M., OD, FAAOAcademic/Hospital1112007
Laboratoires TheaFor profit1112011
Laboratorios PoenFor profit1112021
Laboratorios Sophia S.A de C.V.For profit1112014
37 organizations
Page 1 / 2

Marketing (47)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGFeb 19, 2020
ActavisFor profitMKTGAug 27, 2014
Akorn, Inc.For profitMKTGDec 5, 2017
Akorn, Inc.For profitSYNJan 10, 2017
AlconFor profitMKTGJan 30, 2015
AlembicFor profitMKTGDec 7, 2018
AlembicFor profitSYNDec 7, 2018
Amneal PharmaceuticalsFor profitSYNJan 28, 2020
Amneal PharmaceuticalsFor profitMKTGJan 28, 2020
ApotexFor profitSYNDec 7, 2015
ApotexFor profitMKTGOct 8, 2014
Aurobindo PharmaFor profitMKTGDec 18, 2015
Barr LaboratoriesFor profitMKTGJul 13, 2015
Bausch & LombFor profitMKTGJul 26, 2017
Bausch Health CompaniesFor profitMKTGJul 26, 2017
CiplaFor profitMKTGJul 26, 2017
Eugia PharmaFor profitMKTGDec 18, 2015
FDCFor profitMKTGSep 26, 2019
FosunFor profitMKTGAug 2, 2019
Gland Pharma LtdFor profitMKTGAug 2, 2019
Gland Pharma LtdFor profitSYNAug 2, 2019
Glenmark PharmaceuticalsFor profitMKTGJun 28, 2017
Glenmark PharmaceuticalsFor profitNDA2Jan 13, 2022
Glenmark PharmaceuticalsFor profitSYNJan 13, 2022
HikmaFor profitMKTGAug 19, 2020
Lachman ConsultantsFor profitMKTGFeb 19, 2020
Micro Labs Ltd IndiaFor profitMKTGJun 16, 2020
MylanFor profitSYNMar 21, 2018
MylanFor profitMKTGMar 21, 2018
NestleFor profitNDA2Dec 18, 1996
NovartisFor profitNDA2Dec 18, 1996
NovartisFor profitNDADec 18, 1996
NovartisFor profitMKTGJan 28, 2010
Padagis UsFor profitMKTGJan 31, 2017
PerrigoFor profitMKTGJan 31, 2017
Rising PharmaceuticalsFor profitMKTGMar 21, 2018
SandozFor profitMKTGJan 28, 2010
Sciegen PharmaceticalsFor profitMKTGJan 10, 2017
Somerset PharmaceuticalsFor profitMKTGDec 7, 2015
Somerset PharmaceuticalsFor profitSYNDec 18, 2024
TevaFor profitMKTGJul 13, 2015
USVFor profitSYNDec 7, 2015
USVFor profitMKTGDec 7, 2015
Watson PharmaceuticalsFor profitMKTGFeb 2, 2015
Watson PharmaceuticalsFor profitSYNAug 27, 2014
WockhardtFor profitMKTGJun 28, 2017
ZambonFor profitMKTGDec 7, 2015