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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
Fuji
Boehringer Ingelheim
Chinese Patent Office
Fish and Richardson
QuintilesIMS
Express Scripts
Covington
Citi

Generated: August 21, 2017

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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 thirty-three patent family members in forty-seven countries.

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

Summary for Generic Name: linagliptin

Tradenames:3
Patents:19
Applicants:1
NDAs:3
Drug Master File Entries: see list17
Suppliers / Packagers: see list2
Bulk Api Vendors: see list46
Clinical Trials: see list108
Patent Applications: see list257
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;ORAL208026-002May 27, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► Subscribe ► 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
8,232,281Uses of DPP-IV inhibitors► Subscribe
7,820,815Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines► Subscribe
7,829,530Method 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
8,513,190Method 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
Norway20031574► Subscribe
World Intellectual Property Organization (WIPO)2010015664► Subscribe
South Africa200500087► Subscribe
Luxembourg92613► Subscribe
South Korea101655754► 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
0872Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2014041Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
0308Netherlands► Subscribe300308, 20170424, EXPIRES: 20220423
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Fuji
US Army
McKinsey
AstraZeneca
Moodys
UBS
Johnson and Johnson
Merck
Boehringer Ingelheim

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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