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Last Updated: July 10, 2020

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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 five 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.

One supplier is listed for this compound.

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

Pharmacology for indacaterol maleate

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   Start Trial   Start Trial Y Y   Start Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011 DISCN Yes No   Start Trial   Start Trial   Start 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 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   Start Trial   Start Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011   Start Trial   Start Trial
Novartis ARCAPTA NEOHALER indacaterol maleate POWDER;INHALATION 022383-001 Jul 1, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for indacaterol maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1183240 SPC009/2010 Ireland   Start Trial SPC009/2010: 20100813, EXPIRES: 20241129
1183240 C 2010 011 Romania   Start 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 7/2010 Austria   Start Trial PRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
1183240 C01183240/01 Switzerland   Start Trial FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
1267866 CA 2014 00020 Denmark   Start Trial PRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, ISAER BROMIDSALTET, I KOMBINATION MED INDACATEROL ELLER ET SALT DERAF, ISAER MALEATSALTET; REG. NO/DATE: EU/1/13/862 20130919
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Boehringer Ingelheim
Moodys
Dow
AstraZeneca
Baxter

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