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Last Updated: March 28, 2024

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ILEVRO Drug Patent Profile


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Which patents cover Ilevro, and what generic alternatives are available?

Ilevro is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four 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.

DrugPatentWatch® Generic Entry Outlook for Ilevro

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 8, 2024. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ILEVRO
Drug Prices for ILEVRO

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Drug Sales Revenue Trends for ILEVRO

See drug sales revenues for ILEVRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Recent Clinical Trials for ILEVRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vance Thompson Vision - MTPhase 4
Alcon ResearchN/A
MDbackline, LLCN/A

See all ILEVRO clinical trials

Pharmacology for ILEVRO
Paragraph IV (Patent) Challenges for ILEVRO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ILEVRO Ophthalmic Suspension nepafenac 0.3% 203491 1 2015-12-21

US Patents and Regulatory Information for ILEVRO

ILEVRO is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ILEVRO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ILEVRO

Ophthalmic compositions containing a synergistic combination of two polymers
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Carboxyvinyl polymer-containing nanoparticle suspensions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Carboxylvinyl polymer-containing nanoparticle suspensions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ILEVRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited Nevanac nepafenac EMEA/H/C/000818
Nevanac is indicated for:, , , prevention and treatment of postoperative pain and inflammation associated with cataract surgery;, reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients., ,
Authorised no no no 2007-12-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ILEVRO

See the table below for patents covering ILEVRO around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 3028692 COMPOSITIONS OPHTHALMIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS) ⤷  Try a Trial
China 100408100 ⤷  Try a Trial
China 100475192 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011068872 ⤷  Try a Trial
Brazil 9811574 composição farmacêutica oftálmica estéril. ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ILEVRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0999825 CA 2013 00055 Denmark ⤷  Try a 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
0999825 92301 Luxembourg ⤷  Try a Trial PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0999825 122013000085 Germany ⤷  Try a Trial PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0716600 C00716600/01 Switzerland ⤷  Try a Trial PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825 C300622 Netherlands ⤷  Try a Trial PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.