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Serving leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Cerilliant
Fish and Richardson
Medtronic
McKesson
Farmers Insurance
QuintilesIMS
McKinsey
Accenture

Generated: October 22, 2017

DrugPatentWatch Database Preview

Linagliptin - Generic Drug Details

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What are the generic sources for linagliptin and what is the scope of linagliptin patent protection?

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

Linagliptin has three hundred and forty-nine patent family members in forty-seven countries and sixty supplementary protection certificates in thirteen countries.

There are seventeen drug master file entries for linagliptin. Two suppliers are listed for this compound.

Summary for Generic Name: linagliptin

US Patents:19
Tradenames:3
Applicants:1
NDAs:3
Drug Master File Entries: see list17
Suppliers / Packagers: see list2
Bulk Api Vendors: see list46
Clinical Trials: see list110
Patent Applications: see list471
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:linagliptin at DailyMed

Pharmacology for Ingredient: linagliptin

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, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-001Jan 30, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-001Jan 30, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-003Jan 30, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: linagliptin

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
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
9,108,9648-[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
8,541,450Process for the preparation of chiral 8-(3-aminopiperidin-1yl)-xanthines► Subscribe
8,232,281Uses of DPP-IV inhibitors► Subscribe
9,499,546Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines► Subscribe
9,321,7918-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► Subscribe
9,556,1758-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and thier use as pharmaceutical compositions► 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

Country Document Number Estimated Expiration
Greece3036788► Subscribe
TaiwanI500423► Subscribe
Japan2016138153► Subscribe
Eurasian Patent Organization200700974► Subscribe
European Patent Office2397142► Subscribe
South Africa200808282► Subscribe
Israel211015► Subscribe
Canada2732803► Subscribe
Serbia52142► Subscribe
Japan2014144985► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00065Denmark► SubscribePRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926
8 5013-2011Slovakia► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
2014045Lithuania► SubscribePRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
11/039Ireland► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
889Luxembourg► Subscribe91889, EXPIRES: 20260824
C/GB14/086United Kingdom► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
0308Netherlands► Subscribe300308, 20170424, EXPIRES: 20220423
2011 00030Denmark► SubscribePRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Citi
Cantor Fitzgerald
Argus Health
Chubb
Mallinckrodt
Merck
Julphar
Queensland 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.

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