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Indacaterol maleate - Generic Drug Details

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What are the generic sources for indacaterol maleate and what is the scope of freedom to operate?

Indacaterol maleate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indacaterol maleate has eighty-six patent family members in thirty-nine countries.

Summary for indacaterol maleate

International Patents:	86
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	24
Patent Applications:	47
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for indacaterol maleate
DailyMed Link:	indacaterol maleate at DailyMed

Recent Clinical Trials for indacaterol maleate

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

Sponsor	Phase
Mundipharma Research Limited	Phase 2/Phase 3
Novartis Pharmaceuticals	Phase 4
Novartis Pharmaceuticals	Phase 3

See all indacaterol maleate clinical trials

US Patents and Regulatory Information for indacaterol maleate

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 indacaterol maleate

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 indacaterol maleate

Country	Patent Number	Estimated Expiration
Czech Republic	302403
Portugal	1183240
Russian Federation	2006143840
Slovenia	1747036
Malaysia	144563

Supplementary Protection Certificates for indacaterol maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1267866	132014902244065	Italy		PRODUCT NAME: INDACATEROLO O UN SUO SALE, IN PARTICOLARE IL SALE MALEATO, E GLICOPIRRONIO O UN SUO SALE, IN PARTICOLARE IL SALE BROMURO, IN ASSOCIAZIONE(ULTIBRO BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/862, 20130919
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
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	C300437	Netherlands		PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130