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Linagliptin - Generic Drug Details

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

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.

This ingredient has three hundred and twenty-four patent family members in forty-five countries.

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

Summary for Generic Name: linagliptin

Tradenames:3
Patents:20
Applicants:1
NDAs:3
Drug Master File Entries: see list16
Suppliers / Packagers: see list2
Bulk Api Vendors: see list46
Clinical Trials: see list28
Patent Applications: see list137
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-002Jan 30, 2012RXYesNo8,673,927► Subscribe ► Subscribe
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes8,673,927► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo7,407,955► SubscribeYY ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-003Jan 30, 2012RXYesYes7,078,381► Subscribe ► Subscribe
Boehringer Ingelheim
JENTADUETO
linagliptin; metformin hydrochloride
TABLET;ORAL201281-001Jan 30, 2012RXYesNo8,846,695► 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
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

Country Document Number Estimated Expiration
Japan5927146► Subscribe
Uruguay30321► Subscribe
BrazilPI1006144► Subscribe
European Patent Office2407168► Subscribe
New Zealand617916► 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
382Luxembourg► Subscribe91382, EXPIRES: 20220424
2014045Lithuania► SubscribePRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
2007 00061Denmark► Subscribe
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923
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
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