Olopatadine

Overview

Olopatadine is a selective histamine H1 antagonist and mast cell stabilizer that works by attenuating inflammatory and allergic reactions. It is a structural analog of doxepin, which has a minimal anti-allergic activity. Olopatadine works by blocking the effects of histamine, which is a primary inflammatory mediator that causes inflammatory and allergic reactions. An ophthalmic solution of olopatadine was approved by the FDA and European Union for the treatment of seasonal and perennial allergic conjunctivitis in 1996 and 2002, respectively. In comparison to other anti-allergenic ophthalmic medications, olopatadine displays a good comfort and tolerability profile since it does not cause perturbation of cell membranes. Olopatadine is used for the symptomatic treatment of ocular itching associated with allergic conjunctivitis in ophthalmic formulations and seasonal allergic rhinitis in intranasal formulations. It is currently marketed under several brand names, including Pazeo, Patanase, and Opatanol.

Indication

Olopatadine is indicated for the symptomatic treatment of ocular itching associated with allergic conjunctivitis as ophthalmic solution. As a nasal spray, as a monotherapy or in combination with mometasone furoate, olopatadine is indicated for the symptomatic relief of seasonal allergic rhinitis in patients 12 years of age and older.

Associated Conditions

Allergic Conjunctivitis (AC)
Allergic Rhinitis (AR)
Seasonal Allergic Rhinitis
Moderate, severe Seasonal Allergic Rhinitis
Ocular effects

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis	2022/04/06	NCT05314621	Phase 4	Completed	Andover Research Eye Institute
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis	2022/03/04	NCT05265910	Phase 4	Completed	Andover Research Eye Institute
Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment	2021/03/01	NCT04776096	Phase 4	Completed	Laboratorios Poen
DEXTENZA Therapy for Treatment of Allergic Conjunctivitis	2021/01/14	NCT04708821	Phase 4	Completed	Clinical Research Center of Florida
Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)	2018/02/23	NCT03444506	Phase 2	Completed	Glenmark Pharmaceuticals Ltd. India
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis	2017/10/25	NCT03320434	Phase 2	Completed	ORA, Inc.
Clinical Evaluation of Hylo-Dual Versus Patanol in Children With Seasonal Allergic Conjunctivitis	2017/06/14	NCT03186755	Phase 4	Recruiting	Michael Marchand, MD
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)	2015/12/16	NCT02631551	Phase 3	Completed	Glenmark Specialty S.A.
Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)	2015/06/23	NCT02478398	Phase 3	Completed	Merck Sharp & Dohme LLC
Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects	2014/12/23	NCT02322216	Phase 3	Completed	Alcon Research

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Olopatadine Hydrochloride	Akorn	50383-943	NASAL	665 ug in 1 1	1/11/2023
OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	62332-501	OPHTHALMIC	1 mg in 1 mL	11/11/2016
OLOPATADINE HYDROCHLORIDE	RPK Pharmaceuticals, Inc.	53002-0510	OPHTHALMIC	1.11 mg in 1 mL	4/26/2023
Pataday	Physicians Total Care, Inc.	54868-6222	OPHTHALMIC	2 mg in 1 mL	1/5/2011
OLOPATADINE HYDROCHLORIDE	Direct Rx	72189-053	OPHTHALMIC	1 mg in 1 mL	10/23/2019
OLOPATADINE HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	62332-502	OPHTHALMIC	2 mg in 1 mL	4/29/2019
OLOPATADINE HYDROCHLORIDE	H.J. Harkins Company, Inc.	76519-1161	OPHTHALMIC	1.11 mg in 1 mL	8/29/2019
olopatadine hydrochloride	Bryant Ranch Prepack	72162-1390	NASAL	665 ug in 1 1	8/31/2023
OLOPATADINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	68071-5085	OPHTHALMIC	1.11 mg in 1 mL	2/19/2021
Olopatadine Hydrochloride	Sandoz Inc	61314-320	NASAL	665 ug in 100 uL	5/23/2016

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Opatanol	Novartis Europharm Limited,Vista Building,Elm Park,Merrion Road,Dublin 4,Ireland	Authorised	5/16/2002

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
ALERCHEK OPHTHALMIC SOLUTION 0.1%	Indoco Remedies Limited	SIN15527P	SOLUTION, STERILE	1.00mg/ml	8/17/2018
ALERCHEK OPHTHALMIC SOLUTION 0.2%	Indoco Remedies Limited	SIN15526P	SOLUTION, STERILE	2.00mg/ml	8/17/2018
PAZEO OPHTHALMIC SOLUTION 0.7%	Alcon Laboratories, Inc. (ASPEX) / (Fort Worth North), S.A. Alcon-Couvreur N.V.	SIN15242P	SOLUTION, STERILE	0.7%	5/22/2017
OLOPAN OPHTHALMIC SOLUTION 0.1% W/V	Beximco Pharmaceuticals Ltd	SIN16569P	SOLUTION	1mg/ml	8/11/2022
PATANOL STERILE OPHTHALMIC SOLUTION 0.1%	ALCON-COUVREUR NV, ALCON SINGAPORE MANUFACTURING PTE. LTD.	SIN10485P	SOLUTION	1mg/ml	12/2/1998
Pataday® Sterile Ophthalmic Solution 0.2%	Alcon Research LLC	SIN13961P	SOLUTION, STERILE	0.2% w/v	5/24/2011
RYALTRIS NASAL SPRAY 600/25MCG	Glenmark Pharmaceuticals Limited	SIN16523P	SPRAY, SUSPENSION	600 MCG/SPRAY	6/28/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OLOPATADINE APOTEX olopatadine (as hydrochloride) 1 mg/mL eye drops bottle	241494	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/15/2016
RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal spray bottle	473905	Seqirus Pty Ltd	Medicine	A	3/28/2025
RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal spray bottle	312690	Seqirus Pty Ltd	Medicine	A	12/11/2019
PALADOPT olopatadine (as hydrochloride) 1 mg/mL eye drop bottle	227798	Viatris Pty Ltd	Medicine	A	10/23/2015
PATANOL 0.1% olopatadine hydrochloride 1.11mg/1mL eye drop bottle	82000	Novartis Pharmaceuticals Australia Pty Ltd	Medicine	A	5/16/2002
GENRX OLOPATADINE olopatadine (as hydrochloride) 1 mg/mL eye drops bottle	241495	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/15/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RYALTRIS	Glenmark Specialty SA	02531186	Spray, Metered Dose - Nasal	665 MCG / ACT	3/17/2023

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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