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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Chubb
Novartis
Farmers Insurance
Mallinckrodt
QuintilesIMS
AstraZeneca
US Army
Argus Health
Daiichi Sankyo

Generated: October 18, 2017

DrugPatentWatch Database Preview

Glycopyrrolate ; indacaterol maleate - Generic Drug Details

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What are the generic sources for glycopyrrolate ; indacaterol maleate and what is the scope of glycopyrrolate ; indacaterol maleate freedom to operate?

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

Glycopyrrolate ; indacaterol maleate has three hundred and fifty-nine patent family members in forty-three countries and twenty-four supplementary protection certificates in ten countries.

There are seventeen drug master file entries for glycopyrrolate ; indacaterol maleate. One supplier is listed for this compound.

Summary for Generic Name: glycopyrrolate ; indacaterol maleate

US Patents:16
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list17
Suppliers / Packagers: see list1
Clinical Trials: see list350
Drug Prices:see low prices
DailyMed Link:glycopyrrolate ; indacaterol maleate at DailyMed

Pharmacology for Ingredient: glycopyrrolate ; 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
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: glycopyrrolate ; indacaterol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: glycopyrrolate ; 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
7,744,855Method of making particles for use in a pharmaceutical composition► Subscribe
9,040,559BETA2-adrenoceptor agonists► Subscribe
7,622,483.beta.2-adrenoceptor agonists► Subscribe
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets► Subscribe
8,871,274Pharmaceutical formulations for dry powder inhalers► Subscribe
8,436,017Beta-2-adrenoreceptor agonists► Subscribe
8,932,635Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation► Subscribe
7,368,104Treatment of respiratory diseases► Subscribe
9,585,839Particles for use in a pharmaceutical composition► Subscribe
7,541,022Pharmaceutical formulations for dry powder inhalers► 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: glycopyrrolate ; indacaterol maleate

Country Document Number Estimated Expiration
South Africa200608728► Subscribe
Hungary0301518► Subscribe
South Africa200109931► Subscribe
New Zealand543026► Subscribe
Australia2004271783► Subscribe
World Intellectual Property Organization (WIPO)2004093848► Subscribe
Spain2288167► Subscribe
Norway336687► Subscribe
New Zealand521887► Subscribe
European Patent Office1274406► 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: GLYCOPYRROLATE ; INDACATEROL MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00583Netherlands► SubscribePRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
3Finland► Subscribe
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
1267866/02Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
2013 00015Denmark► SubscribePRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
2010 00006Denmark► Subscribe
13/014Ireland► SubscribePRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
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
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
166Luxembourg► SubscribePRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Covington
Cerilliant
Cipla
US Department of Justice
Chinese Patent Office
Cantor Fitzgerald
Medtronic
Mallinckrodt

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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