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

Last Updated: November 4, 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
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
Norway 20060978 ⤷  Sign Up
Luxembourg 91651 ⤷  Sign Up
Canada 2538997 COMPOSITIONS PHARMACEUTIQUES PERMETTANT DE TRAITER L'EJACULATION PRECOCE PAR INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS FOR TREATING PREMATURE EJACULATION BY PULMONARY INHALATION) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 0075114 ⤷  Sign Up
European Patent Office 1613323 COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE L'APOMORPHINE POUR L'INHALATION PULMONAIRE (PHARMACEUTICAL COMPOSITIONS COMPRISING APOMORHINE FOR PULMONARY INHALATION) ⤷  Sign Up
Poland 198847 ⤷  Sign Up
Russian Federation 2005135133 ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ⤷  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 C01183240/01 Switzerland ⤷  Sign Up FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1183240 C300437 Netherlands ⤷  Sign Up PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
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 [...]
1183240 10C0006 France ⤷  Sign Up 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
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 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.