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Last Updated: March 29, 2024

GLYCOPYRROLATE; INDACATEROL MALEATE - Generic Drug Details


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What are the generic drug sources for glycopyrrolate; indacaterol maleate and what is the scope of freedom to operate?

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.

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
Novartis UTIBRON glycopyrrolate; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GLYCOPYRROLATE; INDACATEROL MALEATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 C 2010 011 Romania ⤷  Try a Trial 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 SZ 7/2010 Austria ⤷  Try a Trial PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240 C300437 Netherlands ⤷  Try a Trial PRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240 383 Finland ⤷  Try a Trial
>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.