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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
US Army
Johnson and Johnson
Merck
Boehringer Ingelheim
Express Scripts
AstraZeneca
Fish and Richardson
Novartis

Generated: November 19, 2017

DrugPatentWatch Database Preview

ARCAPTA NEOHALER Drug Profile

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What is the patent landscape for Arcapta Neohaler, and when can generic versions of Arcapta Neohaler launch?

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

This drug has eighty-three patent family members in thirty-seven countries and twelve supplementary protection certificates in ten countries.

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

Summary for ARCAPTA NEOHALER

Pharmacology 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
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: ARCAPTA NEOHALER

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,622,483.beta.2-adrenoceptor agonists► Subscribe
8,436,017Beta-2-adrenoreceptor agonists► Subscribe
8,283,362Beta-2-adrenoreceptor agonists► Subscribe
7,820,694Beta-2-adrenoreceptor agonists► Subscribe
9,040,559BETA2-adrenoceptor agonists► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ARCAPTA NEOHALER

Country Document Number Estimated Expiration
Slovenia1183240► Subscribe
European Patent Office1747036► Subscribe
Slovakia17432001► Subscribe
Cyprus1114120► Subscribe
Argentina051353► Subscribe
Australia765919► Subscribe
TaiwanI353857► Subscribe
Japan4914345► Subscribe
Norway322944► Subscribe
Norway2010014► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ARCAPTA NEOHALER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014000025Germany► SubscribePRODUCT 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
C009/2010Ireland► SubscribeSPC009/2010: 20100813, EXPIRES: 20241129
2010 00006Denmark► Subscribe
C/GB10/009United Kingdom► SubscribePRODUCT 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
2014 00020Denmark► SubscribePRODUCT 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
7/2010Austria► SubscribePRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
1183240/01Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
3Finland► Subscribe
651Luxembourg► Subscribe91651, EXPIRES: 20241130
393Luxembourg► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cipla
Boehringer Ingelheim
McKesson
US Department of Justice
Cantor Fitzgerald
Teva
Harvard Business School
Mallinckrodt
Fuji

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 verifification 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.

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