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Serving leading biopharmaceutical companies globally:

UBS
Johnson and Johnson
Moodys
McKesson
US Army
Daiichi Sankyo
Mallinckrodt
Boehringer Ingelheim
Deloitte
Baxter

Generated: October 20, 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for Generic Name: indacaterol maleate

US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list49
Clinical Trials: see list263
Patent Applications: see list1,347
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, 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► SubscribeY ► 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
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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
9,040,559BETA2-adrenoceptor agonists► Subscribe
7,622,483.beta.2-adrenoceptor agonists► Subscribe
8,283,362Beta-2-adrenoreceptor agonists► Subscribe
8,436,017Beta-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
Germany122010000009► Subscribe
Russian Federation2244709► Subscribe
MexicoPA06013081► Subscribe
TaiwanI253447► Subscribe
South Africa200608728► Subscribe
Cyprus1114120► Subscribe
Canada2375810► Subscribe
Hong Kong1102919► Subscribe
Russian Federation2363501► Subscribe
China1353692► 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
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
1183240/01Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
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
00437Netherlands► SubscribePRODUCT NAME: INDACATEROL, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/09/593/001-010 20091130
C009/2010Ireland► SubscribeSPC009/2010: 20100813, EXPIRES: 20241129
7/2010Austria► SubscribePRODUCT NAME: INDACATEROL UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON
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
651Luxembourg► Subscribe91651, EXPIRES: 20241130
3Finland► Subscribe
2010 00006Denmark► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cipla
Citi
Harvard Business School
Chinese Patent Office
Fuji
Accenture
Healthtrust
Johnson and Johnson
Moodys
US Army

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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