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Nepafenac - Generic Drug Details

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Nepafenac is the generic ingredient in two branded drugs marketed by Alcon Pharms Ltd and Alcon Res Ltd, and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and eleven patent family members in twenty-five countries.

There are six drug master file entries for nepafenac. Two suppliers are listed for this compound.

Summary for Generic Name: nepafenac

Tradenames:2
Patents:6
Applicants:2
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packaging: see list2
Therapeutic Class:Ophthalmic Agents

Pharmacology for Ingredient: nepafenac

Clinical Trials for: nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alcon Pharms Ltd
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYes8,071,648<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, 2012RXYes7,947,295<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: nepafenac

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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>
Alcon Pharms Ltd
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 20055,475,034<disabled>
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Non-Orange Book Patents for Generic Ingredient: nepafenac

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
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate<disabled in preview>
8,313,754Ophthalmic compositions containing a synergistic combination of two polymers<disabled in preview>
7,169,767Ophthalmic 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 Ingredient: nepafenac

Country Document Number Estimated Expiration
Canada2586807<disabled in preview>
Japan2008521926<disabled in preview>
World Intellectual Property Organization (WIPO)2006060618<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: NEPAFENAC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
301Luxembourg<disabled>PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0716600/01Switzerland<disabled>PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
00622Netherlands<disabled>PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
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