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 Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, 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-three 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:	20
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	43
Patent Applications:	1,577
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
MEDA Pharma GmbH & Co. KG	Phase 2
Laboratorios Poen	Phase 4
Michael Marchand, MD	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 Antagonist Histamine-1 Receptor Inhibitor 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

Anatomical Therapeutic Chemical (ATC) Classes for OLOPATADINE HYDROCHLORIDE

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Glenmark Pharms Inc	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	200810-001	Jun 28, 2017		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204620-001	Jun 16, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alcon Labs Inc	PATADAY ONCE DAILY RELIEF	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	206276-001	Jan 30, 2015		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eugia Pharma	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209995-001	Apr 4, 2019		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SPRAY, METERED;NASAL	210901-001	Jan 28, 2020	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SPRAY, METERED;NASAL	202853-001	Jan 31, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Florida	OLOPATADINE HYDROCHLORIDE	olopatadine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208637-001	Feb 19, 2020		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 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
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	⤷ 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
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	⤷ Sign Up	⤷ Sign Up
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	⤷ 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
>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
European Patent Office	2709610	COMPOSITION OPHTALMIQUE À CONCENTRATION ÉLEVÉE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)	⤷ Sign Up
European Patent Office	3045172	COMPOSITION OPHTHALMIQUE À CONCENTRATION ÉLEVÉE EN OLOPATADINE (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)	⤷ Sign Up
Taiwan	I544922		⤷ Sign Up
South Africa	201305870	HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION	⤷ Sign Up
Chile	2013002467	Composición oftálmica que comprende al menos 0,67% pero no más de 1,0% p/v de olopatadina disuelta en solucion, peg con un peso molecular de 300 a 500, polivinilpirrolidona, hidroxialquil ß-ciclodextrina, hidroxialquil ?-ciclodextrina o su combinación y cloruro de benzalconio; gotario que comprende a la composición oftálmica; y su uso en el tratamiento de la conjuntivitis alérgica ocular.	⤷ Sign Up
South Korea	20180008868	고농도 올로파타딘 안과용 조성물 (HIGH CONCENTRATION OLOPATADINE OPHTHALMIC COMPOSITION)	⤷ Sign Up
Mexico	340957	COMPOSICION OFTALMICA DE ALTA CONCENTRACION DE OLOPATADINA. (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	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
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
0799044	02C0040	France	⤷ Sign Up	PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
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	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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