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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 seventeen 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
Drug Prices:see low prices

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 Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYes8,921,337Mar 31, 2032Y
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYes6,403,609Jul 17, 2018Y
Alcon Pharms Ltd
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYes7,834,059Jan 31, 2027
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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 Pharms Ltd
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 20055,475,034<disabled>
Alcon Res Ltd
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 20125,475,034<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
8,313,754Ophthalmic compositions containing a synergistic combination of two polymers<disabled in preview>
6,583,124 Ophthalmic compositions containing galactomannan polymers and borate<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 Ingredient: nepafenac

Country Document Number Estimated Expiration
Japan4673339<disabled in preview>
South Africa9806533<disabled in preview>
Japan2007500244<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
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
301Luxembourg<disabled>PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
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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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