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Last Updated: June 3, 2024

OLOPATADINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for olopatadine hydrochloride and what is the scope of freedom to operate?

Olopatadine hydrochloride is the generic ingredient in four branded drugs marketed by Akorn, Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Saptalis Pharms, Somerset Theraps Llc, USV, Zambon Spa, Alcon Labs Inc, Amneal, Apotex Inc, Hikma, Padagis Israel, and Novartis, and is included in twenty-nine NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has thirty-one patent family members in nineteen countries.

There are fourteen drug master file entries for olopatadine hydrochloride. Forty suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for OLOPATADINE HYDROCHLORIDE

International Patents:	31
US Patents:	2
Tradenames:	4
Applicants:	21
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	42
Patent Applications:	1,593
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OLOPATADINE HYDROCHLORIDE
What excipients (inactive ingredients) are in OLOPATADINE HYDROCHLORIDE?	OLOPATADINE HYDROCHLORIDE excipients list
DailyMed Link:	OLOPATADINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for OLOPATADINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Laboratorios Poen	Phase 4
Michael Marchand, MD	Phase 4
Université de Montréal	Phase 4

See all OLOPATADINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for OLOPATADINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	0.1%	SOLUTION; OPHTHALMIC
⤷ Sign Up	⤷ Sign Up	0.2%	SOLUTION;OPHTHALMIC
⤷ Sign Up	⤷ Sign Up	0.1%	SOLUTION;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OLOPATADINE HYDROCHLORIDE

Drug Class	Histamine-1 Receptor Inhibitor Histamine-1 Receptor Antagonist Mast Cell Stabilizer
Mechanism of Action	Histamine H1 Receptor Antagonists
Physiological Effect	Decreased Histamine Release

Medical Subject Heading (MeSH) Categories for OLOPATADINE HYDROCHLORIDE

Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Histamine H1 Antagonists, Non-Sedating

Paragraph IV (Patent) Challenges for OLOPATADINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.7%	206276	1	2015-09-10
PATANASE	Nasal Spray	olopatadine hydrochloride	0.665 mg/ Spray	021861	1	2009-06-29
PATADAY ONCE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.2%	021545	1	2008-09-08
PATADAY TWICE DAILY RELIEF	Ophthalmic Solution	olopatadine hydrochloride	0.1%	020688	1	2006-07-17

US Patents and Regulatory Information for OLOPATADINE HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209619-001	Aug 2, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090918-001	Dec 5, 2017		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SPRAY, METERED;NASAL	213757-001	Aug 19, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209420-001	Apr 29, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Saptalis Pharms	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204723-001	Dec 5, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fdc Ltd	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209282-001	Sep 26, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OLOPATADINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	⤷ Sign Up	⤷ Sign Up
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	⤷ Sign Up	⤷ Sign Up
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	⤷ Sign Up	⤷ Sign Up
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021545-001	Dec 22, 2004	⤷ Sign Up	⤷ Sign Up
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	⤷ Sign Up	⤷ Sign Up
Alcon Labs Inc	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	020688-001	Dec 18, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OLOPATADINE HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Colombia	6801738	Composición oftálmica de alta concentración de olopatadina	⤷ Sign Up
Brazil	112013022057	composição oftálmica de olopatadina de alta concentração	⤷ Sign Up
Mexico	2013010039	COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION.)	⤷ Sign Up
Australia	2012255046	High concentration olopatadine ophthalmic composition	⤷ Sign Up
Hong Kong	1194971	高濃度奧洛他定眼用組合物 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)	⤷ Sign Up
China	105534970	High concentration olopatadine ophthalmic composition	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OLOPATADINE HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	2190041-0	Sweden	⤷ Sign Up	PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	2022C/520	Belgium	⤷ Sign Up	PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	301154	Netherlands	⤷ Sign Up	PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426
0799044	02C0040	France	⤷ Sign Up	PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773	21C1057	France	⤷ Sign Up	PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.