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Glycopyrrolate ; indacaterol maleate - Generic Drug Details

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

This ingredient has three hundred and eighty-six patent family members in forty-six countries.

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

Summary for Generic Name: glycopyrrolate ; indacaterol maleate

Tradenames:1
Patents:18
Applicants:1
NDAs:1
Drug Master File Entries: see list14
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: glycopyrrolate ; indacaterol maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis Pharms Corp
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYes8,283,362► subscribeY ► subscribe
Novartis Pharms Corp
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYes8,048,451► subscribeY ► subscribe
Novartis Pharms Corp
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 2015RXYes8,479,730► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: glycopyrrolate ; indacaterol maleate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
UTIBRON
glycopyrrolate ; indacaterol maleate
POWDER;INHALATION207930-001Oct 29, 20156,521,260► 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
8,871,274Pharmaceutical formulations for dry powder inhalers► subscribe
8,182,791Formulations for use in inhaler devices► 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
Brazil0110141► subscribe
European Patent Office1613323► subscribe
Denmark1663155► 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
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
0583Netherlands► subscribePRODUCT NAME: GLYCOPYRRONIUM EN ALLE DOOR HET BASISOCTROOI BESCHERMDE AFGELEIDEN DAARVAN; REGISTRATION NO/DATE: EU/1/12/788/001-006 20120928
1267866/01Switzerland► subscribeFORMER REPRESENTATIVE: VOSSIUS AND PARTNER, CH
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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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