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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office
Fish and Richardson
McKesson
Julphar
Medtronic
Chubb
Citi
QuintilesIMS
Express Scripts

Generated: December 18, 2017

DrugPatentWatch Database Preview

PATADAY Drug Profile

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When do Pataday patents expire, and when can generic versions of Pataday launch?

Pataday is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty countries and one supplementary protection certificate in one country.

The generic ingredient in PATADAY is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms CorpPATADAYolopatadine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004ATRXYesYes► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpPATADAYolopatadine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004ATRXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: PATADAY

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms CorpPATADAYolopatadine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004► Subscribe► Subscribe
Novartis Pharms CorpPATADAYolopatadine hydrochlorideSOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for PATADAY

Drugname Dosage Strength RLD Submissiondate
olopatadine hydrochlorideOphthalmic Solution0.20%Pataday9/8/2008

Non-Orange Book Patents for Tradename: PATADAY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,977,376Olopatadine formulations for topical nasal administration► Subscribe
8,399,508Olopatadine formulations for topical nasal administration► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: PATADAY

Country Document Number Estimated Expiration
Japan2004536096► Subscribe
Japan2010150292► Subscribe
Portugal1399127► Subscribe
Germany60204142► Subscribe
Australia2002310461► Subscribe
Brazil0210707► Subscribe
Spain2238574► Subscribe
Gulf Cooperation Council0000397► Subscribe
South Korea20040025919► Subscribe
Denmark1399127► 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: PATADAY

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 plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Daiichi Sankyo
Cipla
Medtronic
Citi
Healthtrust
Johnson and Johnson
AstraZeneca
Accenture
Teva

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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