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Last Updated: April 25, 2024

Nepafenac - Generic Drug Details


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What are the generic sources for nepafenac and what is the scope of freedom to operate?

Nepafenac is the generic ingredient in two branded drugs marketed by Harrow Eye and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nepafenac has one hundred and twenty-one patent family members in twenty-eight countries.

There are eight drug master file entries for nepafenac. One supplier is listed for this compound.

Summary for nepafenac
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nepafenac
Generic Entry Dates for nepafenac*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/DROPS;OPHTHALMIC
Generic Entry Dates for nepafenac*:
Constraining patent/regulatory exclusivity:
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 nepafenac

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

SponsorPhase
Kafrelsheikh UniversityPhase 4
Vistar Eye CenterN/A
Virginia Polytechnic Institute and State UniversityN/A

See all nepafenac clinical trials

Pharmacology for nepafenac
Paragraph IV (Patent) Challenges for NEPAFENAC
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 nepafenac

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 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 ⤷  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 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

Expired US Patents for nepafenac

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for nepafenac

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 nepafenac

Country Patent Number Title Estimated Expiration
Canada 2839849 COMPOSITIONS OPHTALMOLOGIQUES CONTENANT UNE ASSOCIATION SYNERGIQUE DE DEUX POLYMERES (OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS) ⤷  Try a Trial
Japan 5864433 ⤷  Try a Trial
Poland 2965749 ⤷  Try a Trial
Mexico 2007006558 FORMULACIONES TOPICAS DE NEPAFENAC. (TOPICAL NEPAFENAC FORMULATIONS.) ⤷  Try a Trial
Lithuania 2965749 ⤷  Try a Trial
Japan 2012041368 TOPICAL NEPAFENAC FORMULATION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nepafenac

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 92301 Luxembourg ⤷  Try a Trial PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
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 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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