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Last Updated: January 24, 2020

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UTIBRON Drug Profile

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Which patents cover Utibron, and what generic alternatives are available?

Utibron is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has three hundred and seventy-five patent family members in forty-four countries.

The generic ingredient in UTIBRON is glycopyrrolate ; indacaterol maleate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrrolate ; indacaterol maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Utibron

Utibron 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.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for UTIBRON
Drug Prices for UTIBRON

See drug prices for UTIBRON

Generic Entry Opportunity Date for UTIBRON
Generic Entry Date for UTIBRON*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Litigation for UTIBRON

Identify potential future generic entrants

District Court Litigation
Case NameDate
Vectura Limited v. GlaxoSmithKline LLC2016-07-27
Novartis AG v. Lee2013-01-14
NOVARTIS AG v. KAPPOS2010-07-06

See all UTIBRON litigation

Synonyms for UTIBRON
1262431-94-6
DTXSID60155126
Glycopyrrolate / indacaterol
Glycopyrrolate mixture with indacaterol
Glycopyrronium bromide / indacaterol
Indacaterol / glycopyrrolate
Indacaterol / glycopyrronium
QVA 149
QVA149
Ultibro Breezhaler
Utibron Neohaler

US Patents and Regulatory Information for UTIBRON

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

Expired US Patents for UTIBRON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for UTIBRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 7/2010 Austria   Start Trial PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1267866 122013000029 Germany   Start Trial PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 CA 2013 00015 Denmark   Start Trial
1267866 C01267866/02 Switzerland   Start Trial FORMER OWNER: SOSEI R&D LTD., GB
1267866 493 Finland   Start Trial
1267866 SPC/GB13/020 United Kingdom   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTERED: UK EU/1/12/788/001 20120928; UK EU/1/12/788/002 20120928; UK EU/1/12/788/003 20120928; UK EU/1/12/788/004 20120928; UK EU/1/12/788/005 20120928; UK EU/1/12/788/006 20120928
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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