UTIBRON NEOHALER Drug Patent Profile

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

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

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

DrugPatentWatch^® Generic Entry Outlook for Utibron Neohaler

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

Indicators of Generic Entry

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Summary for UTIBRON NEOHALER

US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for UTIBRON NEOHALER

UTIBRON NEOHALER is protected by two US patents.

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Glossary

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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 NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Novartis	UTIBRON NEOHALER	glycopyrrolate; indacaterol maleate	POWDER;INHALATION	207930-001	Oct 29, 2015		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for UTIBRON NEOHALER

See the table below for patents covering UTIBRON NEOHALER around the world.

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Country	Patent Number	Title	Estimated Expiration
Austria	256450		⤷ Start Trial
Austria	355822		⤷ Start Trial
Austria	526946		⤷ Start Trial
Australia	4545696		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for UTIBRON NEOHALER

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1183240	C 2010 011	Romania	⤷ Start Trial	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 [...]
1267866	C300651	Netherlands	⤷ Start Trial	PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
1267866	300583	Netherlands	⤷ Start Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1183240	C01183240/01	Switzerland	⤷ Start Trial	FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for UTIBRON NEOHALER

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