MedPath

Olopatadine

Generic Name
Olopatadine
Brand Names
Pataday, Patanase, Patanol, Pazeo, Ryaltris, Opatanol
Drug Type
Small Molecule
Chemical Formula
C21H23NO3
CAS Number
113806-05-6
Unique Ingredient Identifier
D27V6190PM

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.

Background

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
2022/04/06
Phase 4
Completed
Andover Research Eye Institute
2022/03/04
Phase 4
Completed
Andover Research Eye Institute
2021/03/01
Phase 4
Completed
Laboratorios Poen
2021/01/14
Phase 4
Completed
Clinical Research Center of Florida
2018/02/23
Phase 2
Completed
Glenmark Pharmaceuticals Ltd. India
2017/10/25
Phase 2
Completed
ORA, Inc.
2017/06/14
Phase 4
Recruiting
Michael Marchand, MD
2015/12/16
Phase 3
Completed
Glenmark Specialty S.A.
2015/06/23
Phase 3
Completed
2014/12/23
Phase 3
Completed

FDA Drug Approvals

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ALERCHEK OPHTHALMIC SOLUTION 0.1%
SIN15527P
SOLUTION, STERILE
1.00mg/ml
8/17/2018
ALERCHEK OPHTHALMIC SOLUTION 0.2%
SIN15526P
SOLUTION, STERILE
2.00mg/ml
8/17/2018
PAZEO OPHTHALMIC SOLUTION 0.7%
SIN15242P
SOLUTION, STERILE
0.7%
5/22/2017
OLOPAN OPHTHALMIC SOLUTION 0.1% W/V
SIN16569P
SOLUTION
1mg/ml
8/11/2022
PATANOL STERILE OPHTHALMIC SOLUTION 0.1%
SIN10485P
SOLUTION
1mg/ml
12/2/1998
Pataday® Sterile Ophthalmic Solution 0.2%
SIN13961P
SOLUTION, STERILE
0.2% w/v
5/24/2011
RYALTRIS NASAL SPRAY 600/25MCG
SIN16523P
SPRAY, SUSPENSION
600 MCG/SPRAY
6/28/2022

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Olopatadine Hydrochloride Capsules
国药准字H20174034
化学药品
胶囊剂
5/11/2022
Olopatadine Hydrochloride Granules
国药准字H20234298
化学药品
颗粒剂
10/18/2023
Olopatadine Hydrochloride Granules
国药准字H20243652
化学药品
颗粒剂
4/30/2024
Olopatadine Hydrochloride Granules
国药准字H20213583
化学药品
颗粒剂
7/20/2021
Olopatadine Hydrochloride Tablets
国药准字H20203695
化学药品
片剂
12/21/2020
Olopatadine Hydrochloride Tablets
国药准字H20203694
化学药品
片剂
12/21/2020
Olopatadine Hydrochloride Tablets
国药准字H20223262
化学药品
片剂
4/27/2022
Olopatadine Hydrochloride Tablets
国药准字H20237031
化学药品
片剂(薄膜衣片)
8/16/2024
Olopatadine Hydrochloride Tablets
国药准字H20193146
化学药品
片剂
2/4/2024
Olopatadine Hydrochloride Tablets
国药准字H20233157
化学药品
片剂
4/11/2023

PPB Drug Approvals

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