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Last Updated: October 26, 2021

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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 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
AllerganPhase 2
L.V. Prasad Eye InstitutePhase 2
University of Wisconsin, MadisonPhase 4

See all nepafenac clinical trials

Pharmacology for nepafenac
Paragraph IV (Patent) Challenges for NEPAFENAC
Tradename Dosage Ingredient NDA Submissiondate
ILEVRO SUSPENSION/DROPS;OPHTHALMIC nepafenac 203491 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novartis ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491-001 Oct 16, 2012 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for nepafenac

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0999825 92301 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
0999825 122013000085 Germany ⤷  Free Forever Trial PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825 CA 2013 00055 Denmark ⤷  Free Forever 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 ⤷  Free Forever Trial PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0716600 C00716600/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
>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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