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ILEVRO Drug Profile

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Ilevro is a drug marketed by Alcon Res Ltd and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-nine patent family members in twenty-five countries.

The generic ingredient in ILEVRO is nepafenac. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.

Summary for Tradename: ILEVRO

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: ILEVRO

Clinical Trials for: ILEVRO

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYes7,947,295<disabled>Y <disabled>
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYes<disabled><disabled>
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYes6,403,609<disabled>Y <disabled>
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Expired Patents for Tradename: ILEVRO

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 20125,475,034<disabled>
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Paragraph IV activity 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<disabled in preview>
7,709,012Ophthalmic compositions containing a synergistic combination of two polymers<disabled in preview>
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate<disabled in preview>
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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
Spain2206965<disabled in preview>
Canada2781254<disabled in preview>
BrazilPI0411361<disabled in preview>
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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<disabled>PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
2013 00055Denmark<disabled>PRODUCT 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<disabled>PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
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