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Last Updated: January 27, 2023

Indacaterol maleate - Generic Drug Details


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

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

Indacaterol maleate has eighty-six patent family members in thirty-nine countries.

Recent Clinical Trials for indacaterol maleate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mundipharma Research LimitedPhase 2/Phase 3
Novartis PharmaceuticalsPhase 4
Novartis PharmaceuticalsPhase 3

See all indacaterol maleate clinical trials

US Patents and Regulatory Information for 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 ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 indacaterol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 See Plans and Pricing See Plans and Pricing
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 See Plans and Pricing See Plans and Pricing
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for indacaterol maleate

Country Patent Number Title Estimated Expiration
United Kingdom 9913083 See Plans and Pricing
World Intellectual Property Organization (WIPO) 0075114 See Plans and Pricing
Taiwan 200613021 Organic compounds See Plans and Pricing
Poland 352100 See Plans and Pricing
Israel 146578 BETA 2 ADRENOCEPTOR AGONISTS See Plans and Pricing
Turkey 200103497 See Plans and Pricing
Colombia 5170518 COMPUESTOS N-(BENZOCICLOALQUILO) DERIVADOS DE AMINO ARALIFATICOS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for indacaterol maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1267866 122014000025 Germany See Plans and Pricing 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
1183240 SPC/GB10/009 United Kingdom See Plans and Pricing 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 CA 2010 00006 Denmark See Plans and Pricing PRODUCT NAME: INDACATEROL ELLER ET SALT DERAF, HERUNDER INDACATEROLMALEAT
1267866 132014902244065 Italy See Plans and Pricing PRODUCT NAME: INDACATEROLO O UN SUO SALE, IN PARTICOLARE IL SALE MALEATO, E GLICOPIRRONIO O UN SUO SALE, IN PARTICOLARE IL SALE BROMURO, IN ASSOCIAZIONE(ULTIBRO BREEZHALER); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/862, 20130919
1183240 SPC009/2010 Ireland See Plans and Pricing SPC009/2010: 20100813, EXPIRES: 20241129
1183240 7/2010 Austria See Plans and Pricing PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1267866 92393 Luxembourg See Plans and Pricing PRODUCT NAME: GLYCOPYRRONIUM OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL BROMURE, COMBINE A INDACATEROL OU UN SEL DE CELUI-CI, PLUS PARTICULIEREMENT LE SEL MALEATE. FIRST REGISTRATION: 20130923
>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.