Is Olopatadine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 6 valid registrations of Olopatadine, including OLOPAT 0.1 % ophthalmic solution - unit dose (0.1 %, Eye drops, solution, SAR 58.70); OLOPAT 0.1% OPHTHALMIC SOLUTION (0.1 %, Eye drops, solution, SAR 22.05); Olopat (0.2 %, Eye drops, solution, SAR 37.90); PATADAY 0.2% OPHTHALMIC SOLUTION (0.2 %, Eye drops, solution, SAR 37.90); PATANOL 0.1% OPHTHALMIC SOLUTION (0.1 %, Eye drops, solution, SAR 22.05).

Is Olopatadine approved by the US FDA?

Drugs@FDA lists 33 application product lines for Olopatadine, including PATADAY TWICE DAILY RELIEF (Over-the-counter); PATADAY ONCE DAILY RELIEF (Over-the-counter); OLOPATADINE HYDROCHLORIDE (Prescription); PATADAY ONCE DAILY RELIEF (Over-the-counter); OLOPATADINE HYDROCHLORIDE (Over-the-counter).

Is Olopatadine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Olopatadine: Opatanol.

Are there safety signals or safety updates for Olopatadine?

US FDA: 3 entries (latest 2026-07-07).

Active substance

Olopatadine

SFDA 9
US FDA 33
EMA 1
Health Canada 9
US price lines 7
NHS prices 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OLOPAT 0.1 % ophthalmic solution - unit dose	0.1 %	Eye drops, solution · Ophthalmic use	30 Single Dose Container	SAR 58.70	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
OLOPAT 0.1% OPHTHALMIC SOLUTION	0.1 %	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 22.05	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Olopat	0.2 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 37.90	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
PATADAY 0.2% OPHTHALMIC SOLUTION	0.2 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 37.90	Generic · Prescription	NOVARTIS PHARMA AG	Valid
PATANOL 0.1% OPHTHALMIC SOLUTION	0.1 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 22.05	NCE · Prescription	NOVARTIS PHARMA AG	Valid
iPAT	0.1 %	Eye drops, solution · Ophthalmic use	1 Bottle	SAR 19.90	Generic · Prescription	Amman Pharmaceutical Industries (API)	Valid
Olopat	0.7 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 45.50	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Invalid · Not Marketed
PATADAY 0.2% OPHTHALMIC SOLUTION	0.2 %	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 56.75	Generic · Prescription	ALCON LABORATORIES	Withdrawn by MAH · Not Marketed
PATANOL 0.1% OPHTHALMIC SOLUTION	0.1 %	Eye drops, solution · Ophthalmic use	1 Dropper Container	SAR 59.10	NCE · Prescription	ALCON LABORATORIES	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); VIRAL CONJUNCTIVITS, HERPESVIRAL KERATITIS, HERPESVIRAL CONJUNCTIVITIS, VARICELLA KERATITIS, ZOSTER CONJUNCTIVITIS, ZOSTER KERATITIS, MEASLES KERATITIS AND KERATOCONJUNCTIVITIS, VIRAL CONJUNCTIVITIS, KERATITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
PATADAY TWICE DAILY RELIEF	EQ 0.1% BASE	solution/drops · ophthalmic	ALCON LABS INC	Over-the-counter	18 Dec 1996
PATADAY ONCE DAILY RELIEF	EQ 0.2% BASE	solution/drops · ophthalmic	ALCON LABS INC	Over-the-counter	22 Dec 2004
OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	spray, metered · nasal	APOTEX INC	Prescription	8 Oct 2014
PATADAY ONCE DAILY RELIEF	EQ 0.7% BASE	solution/drops · ophthalmic	ALCON LABS INC	Over-the-counter	30 Jan 2015
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	BARR LABS INC	Over-the-counter	13 Jul 2015
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	APOTEX	Over-the-counter	7 Dec 2015
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	USV	Over-the-counter	7 Dec 2015
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Over-the-counter	7 Dec 2015
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	EUGIA PHARMA	Over-the-counter	18 Dec 2015
OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	spray, metered · nasal	PADAGIS ISRAEL	Prescription	31 Jan 2017
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	GLENMARK PHARMS	Over-the-counter	28 Jun 2017
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Over-the-counter	26 Jul 2017
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	APOTEX	Over-the-counter	5 Dec 2017
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Over-the-counter	5 Dec 2017
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	RISING	Over-the-counter	21 Mar 2018
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	ALEMBIC	Over-the-counter	7 Dec 2018
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	EUGIA PHARMA	Over-the-counter	4 Apr 2019
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	ALEMBIC	Over-the-counter	29 Apr 2019
OLOPATADINE HYDROCHLORIDE	EQ 0.1% BASE	solution/drops · ophthalmic	GLAND	Over-the-counter	2 Aug 2019
OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY	spray, metered · nasal	AMNEAL	Prescription	28 Jan 2020
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	GLAND	Over-the-counter	20 May 2020
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	RISING	Over-the-counter	16 Jun 2020
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	SOMERSET	Over-the-counter	18 Dec 2024
OLOPATADINE HYDROCHLORIDE	EQ 0.2% BASE	solution/drops · ophthalmic	GLENMARK PHARMS	Over-the-counter	28 Feb 2025
OLOPATADINE HYDROCHLORIDE	EQ 0.7% BASE	solution/drops · ophthalmic	GLAND	Over-the-counter	6 Jan 2026

8 more — full table

EMA European Union — centrally authorised medicines

Opatanol Novartis Europharm Limited · Authorised · authorised 16 May 2002 · ATC S01GX09

Therapeutic indication (EMA)

Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MINT-OLOPATADINE	02422727	0.1 % / W/V	SOLUTION · OPHTHALMIC	MINT PHARMACEUTICALS INC
MINT-OLOPATADINE 0.2%	02508605	0.2 % / W/V	SOLUTION · OPHTHALMIC	MINT PHARMACEUTICALS INC
OLOPATADINE	02521172	0.1 % / W/V	SOLUTION · OPHTHALMIC	SANIS HEALTH INC
OLOPATADINE 0.2%	02541653	0.2 % / W/V	SOLUTION · OPHTHALMIC	SANIS HEALTH INC
PATADAY	02362171	0.2 % / W/V	SOLUTION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
PATANOL	02233143	0.1 % / W/V	SOLUTION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
PAZEO	02458551	0.7 % / W/V	SOLUTION · OPHTHALMIC	NOVARTIS PHARMACEUTICALS CANADA INC
SANDOZ OLOPATADINE	02358913	0.1 % / W/V	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED
SANDOZ OLOPATADINE 0.2%	02420171	0.2 % / W/V	SOLUTION · OPHTHALMIC	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	GNP OLOPATADINE 0.1% EYE DROPS	$1.27369	per ML	23 Sep 2026
US NADAC	GNP OLOPATADINE 0.2% EYE DROP	$2.96362	per ML	23 Sep 2026
US NADAC	OLOPATADINE 665 MCG NASAL SPRY	$0.8495	per GM	23 Sep 2026
US NADAC	OLOPATADINE HCL 0.1% EYE DROP	$1.27369	per ML	23 Sep 2026
US NADAC	OLOPATADINE HCL 0.1% EYE DROPS	$1.27369	per ML	23 Sep 2026
US NADAC	OLOPATADINE HCL 0.2% EYE DROP	$2.96362	per ML	23 Sep 2026
US NADAC	OLOPATADINE HCL 0.2% EYE DROP	$1.98349	per ML	23 Sep 2026
NHS Drug Tariff	Olopatadine 1mg/ml eye drops	£3.68	5 ml	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 7 Jul 2026 RYALTRIS — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 4 Mar 2021 PATANASE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Jul 2020 PAZEO — safety-related labeling change
Labeling sections changed: Warnings and Precautions

All safety entries for olopatadine →

Combinations containing Olopatadine

Mometasone + olopatadine

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.