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Serving leading biopharmaceutical companies globally:

Deloitte
Merck
Chubb
Julphar
US Army
Daiichi Sankyo
Novartis
Accenture
Fish and Richardson
McKesson

Generated: December 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 sixty 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. Two suppliers are listed for this compound.

Summary for glycopyrrolate ; indacaterol maleate

Pharmacology for 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 IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeYY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;INHALATION207930-001Oct 29, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Sunovion Pharms IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;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 IncUTIBRONglycopyrrolate ; indacaterol maleatePOWDER;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
8,182,791Formulations for use in inhaler devices► Subscribe
9,566,239Pharmaceutical formulations for dry powder inhalers► Subscribe
7,223,748Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets► Subscribe
8,101,160Formulations for use in inhaler devices► Subscribe
7,622,483.beta.2-adrenoceptor agonists► Subscribe
9,585,839Particles for use in a pharmaceutical composition► Subscribe
7,541,022Pharmaceutical formulations for dry powder inhalers► Subscribe
8,871,274Pharmaceutical formulations for dry powder inhalers► Subscribe
7,368,104Treatment of respiratory diseases► Subscribe
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets► 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
Norway2010014► Subscribe
Czech Republic20023437► Subscribe
Luxembourg91651► Subscribe
Germany60125344► Subscribe
Spain2292576► Subscribe
MexicoPA06013081► Subscribe
South Korea20060117909► Subscribe
Morocco26892► Subscribe
Luxembourg92166► Subscribe
Norway332025► 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
0583Netherlands► SubscribePRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
2013 00015Denmark► SubscribePRODUCT NAME: GLYCOPYRRONIUM ELLER ET SALT DERAF, HERUNDER GLYCOPYRRONIUMBROMID; REG. NO/DATE: EU/1/12/788/001-006 20121003
00583Netherlands► SubscribePRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
651Luxembourg► Subscribe91651, EXPIRES: 20241130
C009/2010Ireland► SubscribeSPC009/2010: 20100813, EXPIRES: 20241129
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
1267866/01Switzerland► SubscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
2013 00015Denmark► Subscribe
166Luxembourg► SubscribePRODUCT NAME: GLYCOPYRRONIUM OU UN DE SES SELS
13/014Ireland► SubscribePRODUCT NAME: GLYCOPYRRONIUM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
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Serving leading biopharmaceutical companies globally:

Medtronic
Novartis
McKesson
Chubb
Johnson and Johnson
Baxter
Mallinckrodt
Covington
Colorcon
Chinese Patent Office

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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