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Last Updated: April 22, 2024

UTIBRON Drug Patent Profile


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DrugPatentWatch® 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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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

UTIBRON is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of UTIBRON is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting UTIBRON

Beta2-adrenoceptor agonists
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Dry powder composition comprising co-jet milled particles for pulmonary inhalation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Inhaler device
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for UTIBRON

When does loss-of-exclusivity occur for UTIBRON?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1353
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05245095
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 02666
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0511073
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 63573
Estimated Expiration: ⤷  Try a Trial

China

Patent: 53779
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11555
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066987
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2005027064
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 02919
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8878
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 14345
Estimated Expiration: ⤷  Try a Trial

Patent: 07536962
Estimated Expiration: ⤷  Try a Trial

Patent: 12071146
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4563
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013081
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 612
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0625
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 4854
Estimated Expiration: ⤷  Try a Trial

Patent: 065718
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060098
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 63501
Estimated Expiration: ⤷  Try a Trial

Patent: 06143840
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 47036
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0608728
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1170187
Estimated Expiration: ⤷  Try a Trial

Patent: 070011466
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 62429
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 53857
Estimated Expiration: ⤷  Try a Trial

Patent: 0613021
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 06367
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 10712
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Spain 2368482 ⤷  Try a Trial
Spain 2642073 ⤷  Try a Trial
Japan 2004514504 ⤷  Try a Trial
Poland 359289 ⤷  Try a Trial
Spain 2377205 ⤷  Try a Trial
Austria E502666 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UTIBRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 2014C/022 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), AUTRE, ADRESSE (NO SUPPRIME)
1183240 SZ 7/2010 Austria ⤷  Try a Trial PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1267866 CA 2014 00020 Denmark ⤷  Try a Trial PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
1267866 493 Finland ⤷  Try a Trial
1183240 C300437 Netherlands ⤷  Try a Trial PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240 10C0006 France ⤷  Try a Trial 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
>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.