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Last Updated: September 26, 2022

Nepafenac - Generic Drug Details


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

Nepafenac is the generic ingredient in two branded drugs marketed by Novartis 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 patent family members in twenty-eight countries.

There are eight drug master file entries for nepafenac. Two suppliers are listed for this compound.

Summary for nepafenac
Recent Clinical Trials for nepafenac

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

SponsorPhase
Oslo University HospitalPhase 4
L.V. Prasad Eye InstitutePhase 2
AllerganPhase 2

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
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 See Plans and Pricing See Plans and Pricing
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 See Plans and Pricing See Plans and Pricing
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 See Plans and Pricing See Plans and Pricing
>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 2586807 PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004112836 See Plans and Pricing
South Korea 20150063587 카복시비닐 폴리머를 포함하는 나노입자 현탁액 (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSIONS) See Plans and Pricing
South Korea 101147046 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825 C300622 Netherlands See Plans and Pricing PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0999825 CA 2013 00055 Denmark See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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