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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Citi
Accenture
Cantor Fitzgerald
Queensland Health
Express Scripts
Chinese Patent Office
Teva

Generated: May 24, 2018

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

Glycopyrrolate ; indacaterol maleate has three hundred and sixty-six patent family members in forty-three 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

US Patents and Regulatory Information 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 Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for glycopyrrolate ; indacaterol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ➤ Sign Up ➤ Sign Up
Sunovion Pharms Inc UTIBRON glycopyrrolate ; indacaterol maleate POWDER;INHALATION 207930-001 Oct 29, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,182,791 Formulations for use in inhaler devices ➤ Sign Up
7,368,104 Treatment of respiratory diseases ➤ Sign Up
6,884,794 Pharmaceutical formulations for dry powder inhalers in the form of hard-pellets ➤ Sign Up
8,101,160 Formulations for use in inhaler devices ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for glycopyrrolate ; indacaterol maleate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000029 Germany ➤ Sign Up PRODUCT NAME: GLYKOPYRRONIUM ODER EIN SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
3 Finland ➤ Sign Up
3 Finland ➤ Sign Up
C/GB10/009 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Citi
Julphar
Baxter
Mallinckrodt
Fuji
Teva
AstraZeneca
Argus Health

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.