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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
Merck
Johnson and Johnson
AstraZeneca
McKinsey
US Department of Justice
QuintilesIMS
Cerilliant

Generated: June 21, 2018

DrugPatentWatch Database Preview

ILEVRO Drug Profile

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When do Ilevro patents expire, and when can generic versions of Ilevro launch?

Ilevro is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirteen patent family members in twenty-six countries.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.
Summary for ILEVRO
Drug patent expirations by year for ILEVRO
Pharmacology for ILEVRO

US Patents and Regulatory Information for ILEVRO

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 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ILEVRO
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe 2015-12-21

Non-Orange Book US Patents for ILEVRO

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
7,169,767 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
7,709,012 Ophthalmic compositions containing a synergistic combination of two polymers ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ILEVRO

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

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Chubb
Accenture
Moodys
Mallinckrodt
Johnson and Johnson
Teva

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