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Last Updated: November 2, 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			⤷ 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	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
South Africa	200608728	Inhaler device	⤷ Sign Up
Russian Federation	2363501	ИНГАЛЯТОР (INHALER)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004089374		⤷ Sign Up
China	1882318	Dry powder composition comprising co-jet milled particles for pulmonary inhalation	⤷ Sign Up
Czech Republic	20014301		⤷ Sign Up
Germany	122010000009		⤷ 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	SZ 7/2010	Austria	⤷ Sign Up	PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
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	383	Finland	⤷ Sign Up
1183240	CA 2010 00006	Denmark	⤷ Sign Up	PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1183240	SPC/GB10/009	United Kingdom	⤷ Sign Up	PRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
1183240	C01183240/01	Switzerland	⤷ Sign Up	FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.