NEPAFENAC - Generic Drug Details

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What are the generic drug sources for nepafenac and what is the scope of patent protection?

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. Two suppliers are listed for this compound.

Summary for NEPAFENAC

International Patents:	121
US Patents:	6
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	45
Patent Applications:	3,811
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEPAFENAC
What excipients (inactive ingredients) are in NEPAFENAC?	NEPAFENAC excipients list
DailyMed Link:	NEPAFENAC at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NEPAFENAC

Generic Entry Date for NEPAFENAC^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Vistar Eye Center	N/A
Virginia Polytechnic Institute and State University	N/A

See all NEPAFENAC clinical trials

Pharmacology for NEPAFENAC

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NEPAFENAC

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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

EU/EMA Drug Approvals for NEPAFENAC

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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

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2586426	Suspension de nanoparticules contenant un polymère de type carboxyvinyle (Carboxyvinyl polymer-containing nanoparticle suspensions)	⤷ Sign Up
Japan	5864433		⤷ Sign Up
Spain	2441420		⤷ Sign Up
Slovenia	2586426		⤷ Sign Up
South Korea	101809484		⤷ Sign Up
Spain	2570856		⤷ Sign Up
Australia	2004249137	Ophthalmic compositions containing a synergistic combination of two polymers	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NEPAFENAC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0999825	C300622	Netherlands	⤷ Sign Up	PRODUCT NAME: NEPAFENAC; REGISTRATION NO/DATE: EU/1/07/433/002 20130503
0999825	122013000085	Germany	⤷ Sign Up	PRODUCT NAME: NEPAFENAC (OPHTHALMISCHE SUSPENSION); REGISTRATION NO/DATE: EU 1/07/433/002 20130503
0999825	CA 2013 00055	Denmark	⤷ Sign Up	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
0716600	C00716600/01	Switzerland	⤷ Sign Up	PRODUCT NAME: NEPAFENAC; REGISTRATION NUMBER/DATE: SWISSMEDIC 58745 24.09.2008
0999825	92301	Luxembourg	⤷ Sign Up	PRODUCT NAME: NEPAFENAC-SUSPENSION OPHTALMIQUE
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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