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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 5/16/2002 | ||
Authorised | 5/16/2002 |
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. |
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 | Medicine | A | 2/15/2016 | |
RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal spray bottle | 473905 | Medicine | A | 3/28/2025 | |
RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal spray bottle | 312690 | Medicine | A | 12/11/2019 | |
PALADOPT olopatadine (as hydrochloride) 1 mg/mL eye drop bottle | 227798 | Medicine | A | 10/23/2015 | |
PATANOL 0.1% olopatadine hydrochloride 1.11mg/1mL eye drop bottle | 82000 | Medicine | A | 5/16/2002 | |
GENRX OLOPATADINE olopatadine (as hydrochloride) 1 mg/mL eye drops bottle | 241495 | Medicine | A | 2/15/2016 |