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ARCAPTA NEOHALER Drug Profile

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Which patents cover Arcapta Neohaler, and what substitute generic drugs are available?

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 seventy-four patent family members in thirty-seven 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.

Summary for Tradename: ARCAPTA NEOHALER

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list49
Patent Applications: see list462
Drug Prices:see details
DailyMed Link:ARCAPTA NEOHALER at DailyMed

Pharmacology for Tradename: ARCAPTA NEOHALER

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes8,067,437► Subscribe ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes8,796,307► SubscribeYY ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes8,658,673► SubscribeYY ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes6,878,721► SubscribeYY ► Subscribe
Sunovion Pharms Inc
ARCAPTA NEOHALER
indacaterol maleate
POWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► 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
7,820,694Beta-2-adrenoreceptor agonists► Subscribe
9,040,559BETA2-adrenoceptor agonists► Subscribe
8,436,017Beta-2-adrenoreceptor agonists► Subscribe
8,283,362Beta-2-adrenoreceptor 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
TaiwanI353857► Subscribe
Canada2375810► Subscribe
Portugal1183240► Subscribe
Portugal1747036► Subscribe
Denmark2332915► 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
1183240/01Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
C009/2010Ireland► SubscribeSPC009/2010: 20100813, EXPIRES: 20241129
651Luxembourg► Subscribe91651, EXPIRES: 20241130
00437Netherlands► SubscribePRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 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
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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 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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