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Last Updated: July 6, 2020

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ARCAPTA NEOHALER Drug Profile


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When do Arcapta Neohaler patents expire, and what generic alternatives are available?

Arcapta Neohaler is a drug marketed by Novartis and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-six patent family members in thirty-nine countries.

The generic ingredient in ARCAPTA NEOHALER is indacaterol maleate. One supplier is listed for this compound. Additional details are available on the indacaterol maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Arcapta Neohaler

Arcapta Neohaler was eligible for patent challenges on July 1, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 11, 2028. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ARCAPTA NEOHALER
Drug Prices for ARCAPTA NEOHALER

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Generic Entry Opportunity Date for ARCAPTA NEOHALER
Generic Entry Date for ARCAPTA NEOHALER*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for ARCAPTA NEOHALER

US Patents and Regulatory Information for ARCAPTA NEOHALER

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   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
>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 ARCAPTA NEOHALER

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 ARCAPTA NEOHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 SPC009/2010 Ireland   Start Trial SPC009/2010: 20100813, EXPIRES: 20241129
1183240 C01183240/01 Switzerland   Start Trial FORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
McKinsey
Colorcon
Boehringer Ingelheim
McKesson
AstraZeneca

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