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Last Updated: January 19, 2022

DrugPatentWatch Database Preview

UTIBRON Drug Patent 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 thirteen 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. 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 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 thirteen US patents.

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

This potential generic entry date is based on patent ⤷  Try it Free.

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 it Free
Patent Expiration: ⤷  Try it Free
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Treatment of respiratory disease
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Treatment of respiratory diseases
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: LONG-TERM MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Pharmaceutical compositions for inhalation
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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

Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Inhaler device
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Particles for use in a pharmaceutical composition
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Method of making particles for use in a pharmaceutical composition
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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 it Free ⤷  Try it Free ⤷  Try it Free
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 it Free ⤷  Try it Free
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try it Free ⤷  Try it Free
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try it Free ⤷  Try it Free
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try it Free ⤷  Try it Free
>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 122014000025 Germany ⤷  Try it Free PRODUCT NAME: GLYCOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON (KOMPONENTE 1) UND INDACATEROL ODER EIN DERIVAT HIERVON ODER EIN SALZ VON INDACATEROL ODER EINEM DERIVAT HIERVON (KOMPONENTE 2); REGISTRATION NO/DATE: EU/1/13/862 20130919
1267866 2013C/023 Belgium ⤷  Try it Free PRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS; AUTHORISATION NUMBER AND DATE: EU/1/12/788/001 20121002
1267866 C300651 Netherlands ⤷  Try it Free PRODUCT NAME: COMBINATIE VAN; REGISTRATION NO/DATE: EU/1/13/862/001-006 20130919
1183240 SPC009/2010 Ireland ⤷  Try it Free SPC009/2010: 20100813, EXPIRES: 20241129
>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.