ARCAPTA NEOHALER Drug Patent Profile

When do Arcapta Neohaler patents expire, and what generic alternatives are available?

Arcapta Neohaler is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-six patent family members in thirty-nine countries.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. Additional details are available on the indacaterol maleate profile page.

DrugPatentWatch^® Generic Entry Outlook for Arcapta Neohaler

Arcapta Neohaler was eligible for patent challenges on July 1, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 11, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ARCAPTA NEOHALER

International Patents:	86
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	43
Patent Applications:	190
Drug Prices:	Drug price information for ARCAPTA NEOHALER
DailyMed Link:	ARCAPTA NEOHALER at DailyMed

See drug prices for ARCAPTA NEOHALER

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

NDA:

022383

Dosage:

POWDER;INHALATION

^*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.

Anatomical Therapeutic Chemical (ATC) Classes for ARCAPTA NEOHALER

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for ARCAPTA NEOHALER

ARCAPTA NEOHALER is protected by two 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 ARCAPTA NEOHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No			Y	Y
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011		DISCN	Yes	No			Y

Expired US Patents for ARCAPTA NEOHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011
Novartis	ARCAPTA NEOHALER	indacaterol maleate	POWDER;INHALATION	022383-001	Jul 1, 2011

International Patents for ARCAPTA NEOHALER

When does loss-of-exclusivity occur for ARCAPTA NEOHALER?

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

Argentina

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

Ecuador

European Patent Office

Germany

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

United Kingdom

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 ARCAPTA NEOHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Colombia	5170518	COMPUESTOS N-(BENZOCICLOALQUILO) DERIVADOS DE AMINO ARALIFATICOS
Israel	146578	BETA 2 ADRENOCEPTOR AGONISTS
Mexico	PA06013081	DISPOSITIVO INHALADOR. (INHALER DEVICE.)
Hong Kong	1102919	INHALER DEVICE
World Intellectual Property Organization (WIPO)	0075114
Tunisia	SN06367	INHALER DEVICE
Denmark	1183240

Supplementary Protection Certificates for ARCAPTA NEOHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	122014000025	Germany		PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
1183240	C01183240/01	Switzerland		FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1183240	SZ 7/2010	Austria		PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1267866	CA 2014 00020	Denmark		PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
1183240	C 2010 011	Romania		PRODUCT NAME: INDACATEROL SI SARURILE SALE ACCEPTABILE FARMACEUTICINDACATEROL(R)-5-[2-(5,6-DIETIL-INDAN-2-ILAMINO]-1-HIDROXIETIL]-8-HIDROXI-1H-CHINOLIN-2-ONA; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/593/001, RO EU/1/09/593/002, RO EU/1/09/593/003, RO EU/1/09/593/004, RO EU/1/09/593/005, RO EU/1/09/593/006, RO EU/1/09/593/007, RO EU/1/09/593/008, RO EU/1/09/593/009, RO EU/1/09/593/010; DATE OF NATIONAL AUTHORISATION: 20091130; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/593/001, EMEA EU/1/09/593/002, EMEA EU/1/09/593/003, EMEA EU/1/09/593/004, EMEA EU/1/09/593/005, EMEA EU/1/09/593/006, EMEA EU/1/09/593/007, EMEA EU/1/09/593/008, EMEA EU/1/09/593/009, E [...]
1183240	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240	383	Finland