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Last Updated: April 1, 2023

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 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

UTIBRON is protected by three US patents.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Inhaler device
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 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 ⤷  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 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 ⤷  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 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: ⤷  Sign Up

Australia

Patent: 05245095
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 2666
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0511073
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 63573
Estimated Expiration: ⤷  Sign Up

China

Patent: 53779
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 11555
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 47036
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 066987
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 47036
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2005027064
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 02919
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8878
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 14345
Estimated Expiration: ⤷  Sign Up

Patent: 07536962
Estimated Expiration: ⤷  Sign Up

Patent: 12071146
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 4563
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 06013081
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 612
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0625
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 4854
Estimated Expiration: ⤷  Sign Up

Patent: 065718
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 060098
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 47036
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 47036
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 63501
Estimated Expiration: ⤷  Sign Up

Patent: 06143840
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 47036
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0608728
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1170187
Estimated Expiration: ⤷  Sign Up

Patent: 070011466
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 62429
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 53857
Estimated Expiration: ⤷  Sign Up

Patent: 0613021
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 06367
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 10712
Estimated Expiration: ⤷  Sign Up

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 2288167 ⤷  Sign Up
Japan 2007505832 ⤷  Sign Up
Denmark 1267866 ⤷  Sign Up
Mexico 9705847 PARTICULAS VEHICULOS PARA SU USO EN INHALADORES DE POLVO SECO. (CARRIER PARTICLES FOR USE IN DRY POWDER INHALERS.) ⤷  Sign Up
Hungary 229965 Carrier particles for use in dry powder inhalers ⤷  Sign Up
Slovenia 1232745 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for UTIBRON

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 SPC009/2010 Ireland ⤷  Sign Up SPC009/2010: 20100813, EXPIRES: 20241129
1267866 CA 2014 00020 Denmark ⤷  Sign Up 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
1183240 383 Finland ⤷  Sign Up
1267866 92393 Luxembourg ⤷  Sign Up PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923
1183240 CA 2010 00006 Denmark ⤷  Sign Up PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1183240 7/2010 Austria ⤷  Sign Up PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Dow
McKesson
Johnson and Johnson
Baxter

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.