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Last Updated: January 18, 2021

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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 Novartis and is included in one NDA. There are eighteen patents protecting this drug.

This drug has three hundred and seventy-eight 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 two 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

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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.

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
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis UTIBRON 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

Expired US Patents for UTIBRON

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015   Start Trial   Start Trial
Novartis 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
1267866 2014C/022 Belgium   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME)
1267866 479 Finland   Start Trial
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 C300651 Netherlands   Start Trial PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
1267866 2013/014 Ireland   Start Trial PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.