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Serving leading biopharmaceutical companies globally:

McKesson
US Army
Queensland Health
Accenture
Cantor Fitzgerald
Mallinckrodt
Chubb
Teva
UBS
Deloitte

Generated: December 13, 2017

DrugPatentWatch Database Preview

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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indacaterol maleate has eighty-four patent family members in thirty-eight countries and twelve supplementary protection certificates in ten countries.

Two suppliers are listed for this compound.

Summary for indacaterol maleate

Pharmacology for indacaterol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sunovion Pharms IncARCAPTA NEOHALERindacaterol maleatePOWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncARCAPTA NEOHALERindacaterol maleatePOWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncARCAPTA NEOHALERindacaterol maleatePOWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Sunovion Pharms IncARCAPTA NEOHALERindacaterol maleatePOWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Sunovion Pharms IncARCAPTA NEOHALERindacaterol maleatePOWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Sunovion Pharms IncARCAPTA NEOHALERindacaterol maleatePOWDER;INHALATION022383-001Jul 1, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► 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
7,622,483.beta.2-adrenoceptor agonists► Subscribe
8,436,017Beta-2-adrenoreceptor agonists► Subscribe
9,040,559BETA2-adrenoceptor agonists► Subscribe
8,283,362Beta-2-adrenoreceptor 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
Denmark2332915► Subscribe
Japan2012071146► Subscribe
Slovakia287260► Subscribe
Denmark1747036► Subscribe
Poland352100► Subscribe
Peru02192001► Subscribe
Hong Kong1154584► Subscribe
Canada2375810► Subscribe
Malaysia144563► Subscribe
Hungary0201658► 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
1183240/01Switzerland► SubscribePRODUCT NAME: INDACATEROL; REGISTRATION NO/DATE: SWISSMEDIC 60141 21.05.2010
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
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
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
2010 00006Denmark► Subscribe
7/2010Austria► SubscribePRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
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
C009/2010Ireland► SubscribeSPC009/2010: 20100813, EXPIRES: 20241129
3Finland► Subscribe
651Luxembourg► Subscribe91651, EXPIRES: 20241130
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
McKinsey
Daiichi Sankyo
Queensland Health
QuintilesIMS
McKesson
Citi
Dow
Medtronic
Deloitte

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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