Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Chubb
Moodys
Colorcon
Covington
Dow
Fuji
Johnson and Johnson
Deloitte

Generated: December 10, 2017

DrugPatentWatch Database Preview

Nepafenac - Generic Drug Details

« Back to Dashboard

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 thirty-nine patent family members in twenty-six countries and five supplementary protection certificates in five countries.

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

Pharmacology for nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms CorpNEVANACnepafenacSUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpILEVROnepafenacSUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpILEVROnepafenacSUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpNEVANACnepafenacSUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpNEVANACnepafenacSUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpILEVROnepafenacSUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novartis Pharms CorpILEVROnepafenacSUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms CorpILEVROnepafenacSUSPENSION/DROPS;OPHTHALMIC203491-001Oct 16, 2012► Subscribe► Subscribe
Novartis Pharms CorpNEVANACnepafenacSUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 2005► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: nepafenac

Country Document Number Estimated Expiration
Germany69839355► Subscribe
South Korea20150063587► Subscribe
World Intellectual Property Organization (WIPO)2004112836► Subscribe
Japan2012041368► Subscribe
Australia2004249137► Subscribe
South Korea20110098863► Subscribe
Japan2003528797► Subscribe
South Africa200509440► Subscribe
Mexico2012006231► Subscribe
China101068573► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: NEPAFENAC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2013000085Germany► SubscribePRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
301Luxembourg► SubscribePRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
00622Netherlands► SubscribePRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
AstraZeneca
Covington
Mallinckrodt
Farmers Insurance
Queensland Health
Chubb
Novartis
Accenture
UBS

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot