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PATADAY Drug Profile

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Pataday is a drug marketed by Alcon Pharms Ltd and is included in one NDA. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in twenty countries.

The generic ingredient in PATADAY is olopatadine hydrochloride. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for Tradename: PATADAY

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Drug Prices: :see details

Pharmacology for Tradename: PATADAY

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Pharms Ltd
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004RXYes6,995,186*PED► subscribeY► subscribe
Alcon Pharms Ltd
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 2004RXYes7,402,609*PED► subscribeY► subscribe
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Expired Patents for Tradename: PATADAY

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 20045,116,863*PED► subscribe
Alcon Pharms Ltd
PATADAY
olopatadine hydrochloride
SOLUTION/DROPS;OPHTHALMIC021545-001Dec 22, 20045,641,805*PED► subscribe
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Paragraph IV activity 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
Germany60204142► subscribe
Japan4827374► subscribe
World Intellectual Property Organization (WIPO)03002093► 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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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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