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Serving 500+ biopharmaceutical companies globally:

Deloitte
Julphar
Accenture
Queensland Health
AstraZeneca
US Department of Justice
McKinsey
Argus Health
Federal Trade Commission
Mallinckrodt

Generated: June 27, 2017

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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 indacaterol maleate patent protection?

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

Indacaterol maleate has seventy-five patent family members in thirty-seven countries.

Two suppliers are listed for this compound.

Summary for Generic Name: indacaterol maleate

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list49
Clinical Trials: see list260
Patent Applications: see list910
Drug Prices:see low prices
DailyMed Link:indacaterol maleate at DailyMed

Pharmacology for Ingredient: indacaterol maleate

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, 2011RXYesYes8,796,307► SubscribeYY ► Subscribe
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, 2011RXYesYes8,479,730► SubscribeY ► 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, 2011RXYesYes► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: indacaterol maleate

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
8,436,017Beta-2-adrenoreceptor agonists► Subscribe
7,622,483.beta.2-adrenoceptor agonists► Subscribe
8,283,362Beta-2-adrenoreceptor agonists► Subscribe
9,040,559BETA2-adrenoceptor agonists► Subscribe
7,820,694Beta-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 Ingredient: indacaterol maleate

Country Document Number Estimated Expiration
Austria440083► Subscribe
Japan2012071146► Subscribe
Japan2003501417► Subscribe
Taiwan200613021► Subscribe
TaiwanI253447► 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: INDACATEROL MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2010 00006Denmark► Subscribe
C0006France► SubscribePRODUCT NAME: INDACATEROL OU UN SEL DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/09/593/001 DU 20091130; REGISTRATION NO/DATE AT EEC: EU/1/09/593/001-010 DU 20091130
3Finland► Subscribe
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
00437Netherlands► SubscribePRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Chubb
Cipla
McKesson
Colorcon
Cerilliant
Novartis
UBS
Teva
Moodys

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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