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

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Julphar
Fuji
Mallinckrodt
UBS
Express Scripts
Queensland Health
Baxter
McKinsey
Argus Health

Generated: February 21, 2018

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-eight 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 nepafenac
International Patents:138
US Patents:7
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 8
Suppliers / Packagers: 2
Bulk Api Vendors: 73
Clinical Trials: 32
Patent Applications: 1,355
Drug Prices:see low prices
DailyMed Link:nepafenac at DailyMed
Pharmacology for nepafenac

US Patents and Regulatory Information for 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;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

Expired US Patents for nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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

Non-Orange Book US Patents for 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
7,709,012 Ophthalmic compositions containing a synergistic combination of two polymers ➤ Sign Up
6,583,124 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
7,169,767 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
8,313,754 Ophthalmic compositions containing a synergistic combination of two polymers ➤ Sign Up
6,486,138 Ophthalmic compositions containing galactomannan polymers and borate ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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

International Patents for nepafenac

Supplementary Protection Certificates for nepafenac

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0716600/01 Switzerland ➤ Sign Up PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
2013 00055 Denmark ➤ Sign Up 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
301 Luxembourg ➤ Sign Up PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
2013000085 Germany ➤ Sign Up PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
00622 Netherlands ➤ Sign Up PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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

Serving hundreds of leading biopharmaceutical companies globally:

Merck
US Department of Justice
Cipla
Colorcon
Julphar
Citi
Cantor Fitzgerald
Cerilliant
Medtronic

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.

botpot