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Last Updated: October 4, 2024

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NEVANAC Drug Patent Profile


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Which patents cover Nevanac, and when can generic versions of Nevanac launch?

Nevanac is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-seven patent family members in twenty-three countries.

The generic ingredient in NEVANAC 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.

DrugPatentWatch® Generic Entry Outlook for Nevanac

Nevanac was eligible for patent challenges on August 19, 2009.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 2, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NEVANAC
International Patents:27
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 119
Clinical Trials: 25
Patent Applications: 2,245
Drug Prices: Drug price information for NEVANAC
What excipients (inactive ingredients) are in NEVANAC?NEVANAC excipients list
DailyMed Link:NEVANAC at DailyMed
Drug patent expirations by year for NEVANAC
Drug Prices for NEVANAC

See drug prices for NEVANAC

Drug Sales Revenue Trends for NEVANAC

See drug sales revenues for NEVANAC

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NEVANAC
Generic Entry Date for NEVANAC*:
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 NEVANAC

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

SponsorPhase
Kafrelsheikh UniversityPhase 4
The Research Council of NorwayPhase 4
Ifocus OyeklinikkPhase 4

See all NEVANAC clinical trials

Pharmacology for NEVANAC

US Patents and Regulatory Information for NEVANAC

NEVANAC is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NEVANAC is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 NEVANAC

Topical nepafenac formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING OCULAR INFLAMMATION

Topical nepafenac formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Topical nepafenac formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 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

EU/EMA Drug Approvals for NEVANAC

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 NEVANAC

When does loss-of-exclusivity occur for NEVANAC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2252
Patent: FORMULACIONES TOPICAS DE NEPAFENAC
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 05311738
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 76200
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0518904
Patent: formulaÇÕes de nepafenac tàpicas
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 86807
Patent: PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1068573
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 10780
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 19362
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 19362
Patent: PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2005022756
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 04225
Patent: TOPICAL NEPAFENAC FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 68844
Estimated Expiration: ⤷  Sign Up

Patent: 08521926
Estimated Expiration: ⤷  Sign Up

Patent: 12041368
Patent: TOPICAL NEPAFENAC FORMULATION
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07006558
Patent: FORMULACIONES TOPICAS DE NEPAFENAC. (TOPICAL NEPAFENAC FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 19362
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 19362
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 07124638
Patent: ПРЕПАРАТЫ НЕПАФЕНАКА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 19362
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0704763
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1289661
Estimated Expiration: ⤷  Sign Up

Patent: 070089687
Patent: TOPICAL NEPAFENAC FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 48249
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 58290
Estimated Expiration: ⤷  Sign Up

Patent: 0626132
Patent: Topical nepafenac formulations
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 238
Patent: FORMULACIONES DE NEPAFENAC PARA SU ADMINISTRACION TOPICA
Estimated Expiration: ⤷  Sign Up

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

See the table below for additional patents covering NEVANAC around the world.

Country Patent Number Title Estimated Expiration
Australia 689277 ⤷  Sign Up
Russian Federation 2007124638 ПРЕПАРАТЫ НЕПАФЕНАКА ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ ⤷  Sign Up
Japan 4968844 ⤷  Sign Up
European Patent Office 1819362 PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006060618 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEVANAC

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