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Last Updated: January 30, 2023

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 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-one 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
Vistar Eye CenterN/A
Virginia Polytechnic Institute and State UniversityN/A
Oslo University HospitalPhase 4

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 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
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 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
>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 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
>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 2781254 SUSPENSION DE NANOPARTICULES CONTENANT UN POLYMERE DE TYPE CARBOXYVINYLE (CARBOXYVINYL POLYMER-CONTAINING NANOPARTICLE SUSPENSION) See Plans and Pricing
Uruguay 33081 SUSPENSIONES DE NANOPARTÍCULAS QUE CONTIENEN POLÍMEROS DE CARBOXIVINILO See Plans and Pricing
Japan 4968844 See Plans and Pricing
South Korea 20110098863 OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS See Plans and Pricing
Argentina 080572 SUSPENSIONES DE NANOPARTICULAS QUE CONTIENEN POLIMERO DE CARBOXIVINILO 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 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 C300622 Netherlands See Plans and Pricing PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0716600 C00716600/01 Switzerland See Plans and Pricing PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825 122013000085 Germany See Plans and Pricing PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 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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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Colorcon
Moodys
Merck
McKinsey

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