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Last Updated: June 23, 2024

utibron Drug Patent Profile


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When do Utibron patents expire, and what generic alternatives are available?

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

This drug has one hundred and forty-eight patent family members in forty countries.

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

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

See drug prices for utibron

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 ⤷  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

See the table below for patents covering utibron around the world.

Country Patent Number Title Estimated Expiration
China 100569238 ⤷  Sign Up
China 1438875 ⤷  Sign Up
Brazil 9607490 ⤷  Sign Up
China 1179097 ⤷  Sign Up
European Patent Office 1617820 INHALATEURS A POUDRE SECHE ET FORMULATIONS DE POUDRES SECHES DESTINEES A AUGMENTER L'EFFICACITE DE DOSAGE (DRY POWER INHALER DEVICES AND DRY POWER FORMULATIONS FOR ENHANCING DOSING EFFICIENCY) ⤷  Sign Up
Spain 2153864 ⤷  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 C01183240/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1267866 CA 2013 00015 Denmark ⤷  Sign Up
1183240 C 2010 011 Romania ⤷  Sign Up 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 2013/014 Ireland ⤷  Sign Up PRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866 C01267866/01 Switzerland ⤷  Sign Up FORMER OWNER: SOSEI R&D LTD., GB
1267866 C300651 Netherlands ⤷  Sign Up PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
>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.