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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Covington
Citi
Colorcon
Novartis
McKinsey
Dow
McKesson
Medtronic

Generated: October 23, 2017

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Olopatadine hydrochloride - Generic Drug Details

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What are the generic sources for olopatadine hydrochloride and what is the scope of olopatadine hydrochloride patent protection?

Olopatadine hydrochloride
is the generic ingredient in five branded drugs marketed by Somerset Theraps Llc, Zambon Spa, Wockhardt Ltd, Aurobindo Pharma Ltd, Akorn Inc, Novartis Pharms Corp, Cipla Ltd, Barr Labs Inc, Apotex Inc, Usv North America, and Perrigo Israel, and is included in fifteen NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Olopatadine hydrochloride has fifty-five patent family members in twenty-four countries and one supplementary protection certificate in one country.

There are seventeen drug master file entries for olopatadine hydrochloride. Sixteen suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: olopatadine hydrochloride

US Patents:6
Tradenames:5
Applicants:11
NDAs:15
Drug Master File Entries: see list17
Suppliers / Packagers: see list16
Bulk Api Vendors: see list73
Clinical Trials: see list2,305
Patent Applications: see list2,841
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:olopatadine hydrochloride at DailyMed

Pharmacology for Ingredient: olopatadine hydrochloride

Tentative approvals for OLOPATADINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe0.2% BASESOLUTION; OPHTHALMIC
u► Subscribe0.1%SOLUTION; OPHTHALMIC
u► Subscribe0.1%SOLUTION/DROPS; OPHTHALMIC
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004ATRXYesYes► Subscribe► SubscribeY► Subscribe
Wockhardt Ltd
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC200810-001Jun 28, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
Usv North America
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC203152-001Dec 7, 2015ATRXNoNo► Subscribe► Subscribe► Subscribe
Cipla Ltd
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC206046-001Jul 26, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SPRAY, METERED;NASAL091572-001Oct 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PAZEO
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC206276-001Jan 30, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Akorn Inc
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC204532-001Jan 10, 2017ATRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PATANASE
olopatadine hydrochloride
SPRAY, METERED;NASAL021861-001Apr 15, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma Ltd
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC204812-001Dec 18, 2015ATRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
PATANASE
olopatadine hydrochloride
SPRAY, METERED;NASAL021861-001Apr 15, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: olopatadine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004► Subscribe► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 1996► Subscribe► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 1996► Subscribe► Subscribe
Novartis Pharms Corp
PATANASE
olopatadine hydrochloride
SPRAY, METERED;NASAL021861-001Apr 15, 2008► Subscribe► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 1996► Subscribe► Subscribe
Novartis Pharms Corp
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004► Subscribe► Subscribe
Novartis Pharms Corp
PATANOL
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC020688-001Dec 18, 1996► Subscribe► Subscribe
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International Patent Family for Ingredient: olopatadine hydrochloride

Country Document Number Estimated Expiration
Japan2013127005► Subscribe
Taiwan201249437► Subscribe
South Korea100884711► Subscribe
Japan5940146► Subscribe
Australia2002310461► Subscribe
Colombia6801738► Subscribe
Ukraine114597► Subscribe
Canada2826725► Subscribe
China103458894► Subscribe
South Africa200308771► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OLOPATADINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0040France► SubscribePRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
McKinsey
Express Scripts
Federal Trade Commission
US Department of Justice
Baxter
US Army
Healthtrust
Daiichi Sankyo
McKesson

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 verifification 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.

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