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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Moodys
Queensland Health
Chinese Patent Office
Teva
Citi
Daiichi Sankyo
QuintilesIMS
Argus Health

Generated: August 17, 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. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.

Drug patent expirations by year for ILEVRO
Generic Entry Opportunity Date for ILEVRO
Generic Entry Date for ILEVRO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION/DROPS;OPHTHALMIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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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Expired US Patents for ILEVRO

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 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ILEVRO
Drugname Dosage Strength RLD Date
➤ Subscribe Ophthalmic Suspension 0.3% ➤ Subscribe ➤ Try a Free Trial

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
8,313,754 Ophthalmic compositions containing a synergistic combination of two polymers ➤ Try a Free Trial
6,486,138 Ophthalmic compositions containing galactomannan polymers and borate ➤ Try a Free Trial
6,838,449 Ophthalmic compositions containing galactomannan polymers and borate ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ILEVRO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00622 Netherlands ➤ Try a Free Trial PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
2013 00055 Denmark ➤ Try a Free Trial 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 ➤ Try a Free Trial 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:

McKinsey
US Army
US Department of Justice
Covington
Mallinckrodt
Daiichi Sankyo
UBS
Harvard Business School
Queensland Health

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.