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Linagliptin - Generic Drug Details

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Linagliptin is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and is included in three 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 thirteen patent family members in forty-five countries.

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

Summary for Generic Name: linagliptin

Tradenames:3
Patents:17
Applicants:1
NDAs:3
Drug Master File Entries: see list15
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYes6,635,280► subscribeY ► subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXNo6,488,962► subscribeY ► subscribe
Boehringer Ingelheim
JENTADUETO XR
linagliptin; metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYes6,303,661► 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
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► subscribe
7,820,815Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines► subscribe
7,157,429Method 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
Canada2252576► subscribe
European Patent Office1084705► subscribe
Eurasian Patent Organization200700974► 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
2014043Lithuania► subscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
1084705/05Switzerland► subscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
C/GB14/084United Kingdom► subscribePRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
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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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