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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
Daiichi Sankyo
Mallinckrodt
Cerilliant
Covington
Moodys
Deloitte
Boehringer Ingelheim
Accenture

Generated: September 20, 2017

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Nepafenac - Generic Drug Details

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What are the generic sources for nepafenac and what is the scope of nepafenac patent protection?

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

Nepafenac has one hundred and twenty-five patent family members in twenty-six countries.

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

Summary for Generic Name: nepafenac

Tradenames:2
Patents:7
Applicants:1
NDAs:2
Drug Master File Entries: see list8
Suppliers / Packagers: see list2
Bulk Api Vendors: see list65
Clinical Trials: see list32
Patent Applications: see list1,355
Therapeutic Class:Ophthalmic Agents
Drug Prices:see low prices
DailyMed Link:nepafenac at DailyMed

Pharmacology for Ingredient: nepafenac

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
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis Pharms Corp
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYesYes► Subscribe► Subscribe ► 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
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005► Subscribe► Subscribe
Novartis Pharms Corp
ILEVRO
nepafenac
SUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012► Subscribe► Subscribe
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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
6,486,138 Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
7,709,012Ophthalmic compositions containing a synergistic combination of two polymers► Subscribe
7,169,767Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
6,583,124 Ophthalmic compositions containing galactomannan polymers and borate► Subscribe
8,313,754Ophthalmic compositions containing a synergistic combination of two polymers► 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 Ingredient: nepafenac

Country Document Number Estimated Expiration
Taiwan201129395► Subscribe
South Korea101543613► Subscribe
Serbia53085► Subscribe
Canada2839898► Subscribe
Portugal2116227► Subscribe
World Intellectual Property Organization (WIPO)2004112836► Subscribe
European Patent Office2361610► Subscribe
Slovenia2586426► Subscribe
Cyprus1114252► Subscribe
Cyprus1110365► 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: NEPAFENAC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000085Germany► SubscribePRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
301Luxembourg► SubscribePRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0716600/01Switzerland► SubscribePRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
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
00622Netherlands► SubscribePRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Novartis
Federal Trade Commission
Mallinckrodt
Johnson and Johnson
UBS
Cerilliant
Covington
Julphar
Deloitte

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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