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NEVANAC Drug Patent Profile

Which patents cover Nevanac, and when can generic versions of Nevanac launch?

Nevanac is a drug marketed by Harrow Eye and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-seven patent family members in twenty-three countries.

The generic ingredient in NEVANAC 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 Nevanac

Nevanac was eligible for patent challenges on August 19, 2009.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 2, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEVANAC

International Patents:	27
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	25
Patent Applications:	2,245
Drug Prices:	Drug price information for NEVANAC
What excipients (inactive ingredients) are in NEVANAC?	NEVANAC excipients list
DailyMed Link:	NEVANAC at DailyMed

See drug prices for NEVANAC

See drug sales revenues for NEVANAC

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

NDA:

021862

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 NEVANAC

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

Sponsor	Phase
Kafrelsheikh University	Phase 4
Ifocus Oyeklinikk	Phase 4
The Research Council of Norway	Phase 4

See all NEVANAC clinical trials

Pharmacology for NEVANAC

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

US Patents and Regulatory Information for NEVANAC

NEVANAC is protected by three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NEVANAC

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

Expired US Patents for NEVANAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	NEVANAC	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	021862-001	Aug 19, 2005

EU/EMA Drug Approvals for NEVANAC

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 NEVANAC

When does loss-of-exclusivity occur for NEVANAC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Hong Kong

Japan

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NEVANAC around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1819362	PREPARATIONS TOPIQUES A BASE DE NEPAFENAC (TOPICAL NEPAFENAC FORMULATIONS)
Spain	2171543
Australia	2005311738	Topical nepafenac formulations
South Korea	101289661
Japan	2866744
Taiwan	I358290
Japan	H08510479

Supplementary Protection Certificates for NEVANAC

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