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ILEVRO Drug Patent Profile

Which patents cover Ilevro, and what generic alternatives are available?

Ilevro is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in twenty-six countries.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.

DrugPatentWatch^® Generic Entry Outlook for Ilevro

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ILEVRO

International Patents:	94
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	5
Patent Applications:	2,245
Drug Prices:	Drug price information for ILEVRO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ILEVRO
What excipients (inactive ingredients) are in ILEVRO?	ILEVRO excipients list
DailyMed Link:	ILEVRO at DailyMed

See drug prices for ILEVRO

See drug sales revenues for ILEVRO

Recent Clinical Trials for ILEVRO

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

Sponsor	Phase
Vance Thompson Vision - MT	Phase 4
Alcon Research	N/A
MDbackline, LLC	N/A

See all ILEVRO clinical trials

Pharmacology for ILEVRO

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

Paragraph IV (Patent) Challenges for ILEVRO

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 ILEVRO

ILEVRO is protected by three US patents.

Patents protecting ILEVRO

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			Y
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012		RX	Yes	Yes			Y

Expired US Patents for ILEVRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012

EU/EMA Drug Approvals for ILEVRO

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

International Patents for ILEVRO

See the table below for patents covering ILEVRO around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2012127675	СУСПЕНЗИИ НАНОЧАСТИЦ, СОДЕРЖАЩИЕ КАРБОКСИВИНИЛОВЫЙ ПОЛИМЕР
South Korea	20060012024	OPHTHALMIC COMPOSITIONS CONTAINING A SYNERGISTIC COMBINATION OF TWO POLYMERS
Hungary	E025838
Japan	2003528797
Australia	737442
Denmark	2116227
Canada	2296080	COMPOSITIONS OPHTALMOLOGIQUES CONTENANT DES POLYMERES DE GALACTOMANNAN ET DU BORATE (OPHTHALMIC COMPOSITIONS CONTAINING GALACTOMANNAN POLYMERS AND BORATE)

Supplementary Protection Certificates for ILEVRO

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