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Serving leading biopharmaceutical companies globally:

Citi
Colorcon
Farmers Insurance
Covington
McKinsey
Healthtrust
Express Scripts
Argus Health
Queensland Health
Harvard Business School

Generated: December 12, 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 fifty-two 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.

Pharmacology for linagliptin

Medical Subject Heading (MeSH) Categories for linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJENTADUETOlinagliptin; metformin hydrochlorideTABLET;ORAL201281-002Jan 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimJENTADUETOlinagliptin; metformin hydrochlorideTABLET;ORAL201281-001Jan 30, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-002May 27, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimJENTADUETO XRlinagliptin; metformin hydrochlorideTABLET, EXTENDED RELEASE;ORAL208026-001May 27, 2016RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimJENTADUETOlinagliptin; metformin hydrochlorideTABLET;ORAL201281-002Jan 30, 2012RXYesNo► Subscribe► 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 IngelheimTRADJENTAlinagliptinTABLET;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
9,321,7918-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► Subscribe
6,803,357 Method 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
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
9,556,1758-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and thier use as pharmaceutical compositions► Subscribe
8,232,281Uses of DPP-IV inhibitors► Subscribe
9,108,9648-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► Subscribe
9,751,855Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines► Subscribe
8,664,2328-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions► 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
World Intellectual Property Organization (WIPO)2010079197► Subscribe
Eurasian Patent Organization016752► Subscribe
Ukraine107182► Subscribe
TaiwanI500423► Subscribe
Japan2014058581► Subscribe
Japan2012514589► Subscribe
Luxembourg92615► Subscribe
Slovenia2015754► Subscribe
European Patent Office2407168► Subscribe
Ukraine97468► 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 00063Denmark► SubscribePRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
2011 00030Denmark► Subscribe
00707Netherlands► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
C/GB14/082United Kingdom► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
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
2014044Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
90035-4Sweden► SubscribePRODUCT NAME: LINAGLIPTIN, DESS ENANTIOMERER OCH SALTER DAERAV; REG. NO/DATE: EU/1/11/707/001 20110824
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
2014 00063Denmark► SubscribePRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
C/GB14/086United Kingdom► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Chinese Patent Office
Baxter
Deloitte
Cantor Fitzgerald
Accenture
Fish and Richardson
McKinsey
Moodys

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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