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Last Updated: March 19, 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. One supplier is 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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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
Ifocus OyeklinikkPhase 4
The Research Council of NorwayPhase 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 ⤷  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 NEVANAC

Topical nepafenac formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING OCULAR INFLAMMATION

Topical nepafenac formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Topical nepafenac formulations
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 NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 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 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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05311738
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 76200
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0518904
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 86807
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1068573
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 10780
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 19362
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 19362
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005022756
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 04225
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 68844
Estimated Expiration: ⤷  Try a Trial

Patent: 08521926
Estimated Expiration: ⤷  Try a Trial

Patent: 12041368
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 07006558
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 19362
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 19362
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 07124638
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 19362
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0704763
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1289661
Estimated Expiration: ⤷  Try a Trial

Patent: 070089687
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 48249
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 58290
Estimated Expiration: ⤷  Try a Trial

Patent: 0626132
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 238
Estimated Expiration: ⤷  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.

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

Country Patent Number Title Estimated Expiration
South Korea 101289661 ⤷  Try a Trial
Taiwan I358290 ⤷  Try a Trial
Denmark 0716600 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NEVANAC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0999825 92301 Luxembourg ⤷  Try a Trial PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0999825 C300622 Netherlands ⤷  Try a Trial PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0999825 122013000085 Germany ⤷  Try a Trial 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

Make Better Decisions: Try a trial or see plans & pricing

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.