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Serving leading biopharmaceutical companies globally:

US Army
Cipla
Novartis
Fuji
Daiichi Sankyo
Johnson and Johnson
Boehringer Ingelheim
US Department of Justice
Colorcon
Mallinckrodt

Generated: November 21, 2017

DrugPatentWatch Database Preview

ILEVRO Drug Profile

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What is the patent landscape for Ilevro, and when can generic versions of Ilevro launch?

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

This drug has one hundred and twelve patent family members in twenty-six countries and five supplementary protection certificates in five countries.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.
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
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: ILEVRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for ILEVRO

Drugname Dosage Strength RLD Submissiondate
nepafenacOphthalmic Suspension0.3%Ilevro12/21/2015

Non-Orange Book Patents for Tradename: ILEVRO

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
6,486,138 Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
7,169,767Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
7,709,012Ophthalmic compositions containing a synergistic combination of two polymers► Subscribe
8,313,754Ophthalmic compositions containing a synergistic combination of two polymers► Subscribe
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
6,583,124 Ophthalmic compositions containing galactomannan polymers and borate► 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: ILEVRO

Country Document Number Estimated Expiration
China1762381► Subscribe
Japan2016106155► Subscribe
Slovenia2586426► Subscribe
Hong Kong1055392► Subscribe
Spain2415738► Subscribe
South Korea20120099269► Subscribe
Denmark2116227► Subscribe
World Intellectual Property Organization (WIPO)9906023► Subscribe
Cyprus1114252► Subscribe
Japan3979783► 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: ILEVRO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00622Netherlands► SubscribePRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
2013000085Germany► SubscribePRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
2013 00055Denmark► SubscribePRODUCT NAME: NEPAFENAC (3 MG/ML), HERUNDER NEPAFENAC I KOMBINATION MED GLACTOMANNANPOLYMERER, ISAER 3 MG/ML NEPAFENAC I KOMBINATION MED GALACTOMANNANPOLYMERER, SAMT OFTALMISKE SAMMENSAETNINGER DERAF; REG. NO/DATE: EU1/07/433/002 20130503
0716600/01Switzerland► SubscribePRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
301Luxembourg► SubscribePRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Fuji
McKinsey
Queensland Health
Federal Trade Commission
Cipla
Cantor Fitzgerald
Moodys
AstraZeneca

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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