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Linagliptin; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for linagliptin; metformin hydrochloride?

Linagliptin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Boehringer Ingelheim and is included in two NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and seventy-two patent family members in forty-five countries.

There are sixteen drug master file entries for linagliptin; metformin hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: linagliptin; metformin hydrochloride

Tradenames:2
Patents:18
Applicants:1
NDAs:2
Drug Master File Entries: see list16
Suppliers / Packagers: see list2
Clinical Trials: see list1,707
Drug Prices:see low prices
DailyMed Link:linagliptin; metformin hydrochloride at DailyMed

Pharmacology for Ingredient: linagliptin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-003Jan 30, 2012RXYesYes8,119,648► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-001Jan 30, 2012RXYesNo8,119,648► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012RXYesNo8,119,648► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-003Jan 30, 2012RXYesYes8,178,541► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012RXYesNo8,673,927► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: linagliptin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 20166,340,475► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 20166,635,280► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 20166,635,280► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 20166,340,475► Subscribe
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Non-Orange Book Patents for Generic Ingredient: linagliptin; metformin hydrochloride

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
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,664,2328-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► Subscribe
8,232,281Uses of DPP-IV inhibitors► Subscribe
9,499,546Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► 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: linagliptin; metformin hydrochloride

Country Document Number Estimated Expiration
Japan2012211174► Subscribe
European Patent Office2285410► Subscribe
Japan2005041885► Subscribe
European Patent Office1294363► Subscribe
South Korea20050104428► 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: LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705/01Switzerland► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
2012Austria► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1084705/05Switzerland► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
00569Netherlands► SubscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
00709Netherlands► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
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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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