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Last Updated: November 4, 2024

GLYCOPYRROLATE; INDACATEROL MALEATE - Generic Drug Details

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

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

Glycopyrrolate; indacaterol maleate has one hundred and forty-eight patent family members in forty countries.

Summary for GLYCOPYRROLATE; INDACATEROL MALEATE

International Patents:	148
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	GLYCOPYRROLATE; INDACATEROL MALEATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLYCOPYRROLATE; INDACATEROL MALEATE

Generic Entry Date for GLYCOPYRROLATE; INDACATEROL MALEATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 GLYCOPYRROLATE; INDACATEROL MALEATE

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

US Patents and Regulatory Information for GLYCOPYRROLATE; INDACATEROL MALEATE

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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
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	⤷ 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 GLYCOPYRROLATE; INDACATEROL MALEATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
Novartis	UTIBRON	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for GLYCOPYRROLATE; INDACATEROL MALEATE

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Country	Patent Number	Title	Estimated Expiration
Norway	20060978		⤷ Sign Up
Luxembourg	91651		⤷ Sign Up
Canada	2538997	COMPOSITIONS PHARMACEUTIQUES PERMETTANT DE TRAITER L'EJACULATION PRECOCE PAR INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS FOR TREATING PREMATURE EJACULATION BY PULMONARY INHALATION)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	0075114		⤷ Sign Up
European Patent Office	1613323	COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'APOMORPHINE POUR L'INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS COMPRISING APOMORHINE FOR PULMONARY INHALATION)	⤷ Sign Up
Poland	198847		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for GLYCOPYRROLATE; INDACATEROL MALEATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	C01183240/01	Switzerland	⤷ Sign Up	FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1183240	C300437	Netherlands	⤷ Sign Up	PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240	C 2010 011	Romania	⤷ Sign Up	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	10C0006	France	⤷ Sign Up	PRODUCT NAME: INDACATEROL OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/09/593/001 DU 20091130; REGISTRATION NO/DATE AT EEC: EU/1/09/593/001-010 DU 20091130
1183240	SPC009/2010	Ireland	⤷ Sign Up	SPC009/2010: 20100813, EXPIRES: 20241129
1183240	SZ 7/2010	Austria	⤷ Sign Up	PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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