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Serving 500+ biopharmaceutical companies globally:

Dow
Johnson and Johnson
McKinsey
Novartis
Federal Trade Commission
Argus Health
Medtronic
Chinese Patent Office
Express Scripts
Colorcon

Generated: June 27, 2017

DrugPatentWatch Database Preview

Linagliptin; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources for linagliptin; metformin hydrochloride and what is the scope of linagliptin; metformin hydrochloride patent protection?

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

Linagliptin; metformin hydrochloride has three hundred and eighty patent family members in forty-seven countries.

There are seventeen drug master file entries for linagliptin; metformin hydrochloride. Three 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 list17
Suppliers / Packagers: see list3
Clinical Trials: see list3,974
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo8,883,805► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes8,119,648► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-003Jan 30, 2012RXYesYes8,673,927► Subscribe ► 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;ORAL208026-002May 27, 20166,340,475► 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;ORAL208026-001May 27, 20166,303,661► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 20166,635,280► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-001Jan 30, 20126,303,661► 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
9,044,424Methods 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
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
9,321,7918-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► Subscribe
7,820,815Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines► 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
Australia3023397► Subscribe
New Zealand617916► Subscribe
Japan2014231527► Subscribe
Eurasian Patent Organization010303► Subscribe
Uruguay29190► 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
90035-4Sweden► SubscribePRODUCT NAME: LINAGLIPTIN, DESS ENANTIOMERER OCH SALTER DAERAV; REG. NO/DATE: EU/1/11/707/001 20110824
2014044Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
1084705/02Switzerland► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008
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
00705Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Daiichi Sankyo
Farmers Insurance
Chubb
Chinese Patent Office
Express Scripts
Harvard Business School
Deloitte
Cipla

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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