You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 23, 2024

Glycopyrrolate; indacaterol maleate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for glycopyrrolate; indacaterol maleate and what is the scope of patent protection?

Glycopyrrolate; indacaterol maleate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Glycopyrrolate; indacaterol maleate has one hundred and forty-eight patent family members in forty countries.

Summary for glycopyrrolate; indacaterol maleate
International Patents:148
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:glycopyrrolate; indacaterol maleate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for glycopyrrolate; indacaterol maleate
Generic Entry Date for glycopyrrolate; indacaterol maleate*:
Constraining patent/regulatory exclusivity:
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.

Anatomical Therapeutic Chemical (ATC) Classes for glycopyrrolate; indacaterol maleate

US Patents and Regulatory Information for glycopyrrolate; indacaterol maleate

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 glycopyrrolate; indacaterol maleate

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for glycopyrrolate; indacaterol maleate

Country Patent Number Title Estimated Expiration
Japan 2007505832 ⤷  Sign Up
Norway 334854 ⤷  Sign Up
Australia 2004231342 Dry power inhaler devices and dry power formulations for enhancing dosing efficiency ⤷  Sign Up
Argentina 051353 INHALADOR PARA MEDICAMENTOS EN POLVO. ⤷  Sign Up
European Patent Office 1183240 AGONISTES DU RECEPTEUR BETA 2-ADRENERGIQUE (BETA2-ADRENOCEPTOR AGONISTS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for glycopyrrolate; indacaterol maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 SPC009/2010 Ireland ⤷  Sign Up SPC009/2010: 20100813, EXPIRES: 20241129
1183240 SZ 7/2010 Austria ⤷  Sign Up PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240 SPC/GB10/009 United Kingdom ⤷  Sign Up PRODUCT NAME: INDACATEROL OR A SALT THEREOF; REGISTERED: UK EU/1/09/593/001 20091130; UK EU/1/09/593/002 20091130; UK EU/1/09/593/003 20091130; UK EU/1/09/593/004 20091130; UK EU/1/09/593/005 20091130; UK EU/1/09/593/006 20091130; UK EU/1/09/593/007 20091130; UK EU/1/09/593/008 20091130; UK EU/1/09/593/009 20091130; UK EU/1/09/593/010 20091130
1183240 C300437 Netherlands ⤷  Sign Up PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240 91651 Luxembourg ⤷  Sign Up 91651, EXPIRES: 20241130
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.