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Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
Citi
Moodys
Mallinckrodt
Queensland Health
Dow
Federal Trade Commission
AstraZeneca
Fuji

Generated: December 17, 2017

DrugPatentWatch Database Preview

TRADJENTA Drug Profile

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Which patents cover Tradjenta, and what generic alternatives are available?

Tradjenta is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and fifty-two patent family members in forty-seven countries and sixty supplementary protection certificates in thirteen countries.

The generic ingredient in TRADJENTA is linagliptin. There are seventeen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin profile page.
Drug patent expirations by year for TRADJENTA

Pharmacology for TRADJENTA

Medical Subject Heading (MeSH) Categories for TRADJENTA

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► SubscribeYY► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Boehringer IngelheimTRADJENTAlinagliptinTABLET;ORAL201280-001May 2, 2011RXYesYes► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for TRADJENTA

Drugname Dosage Strength RLD Submissiondate
linagliptinTablets5 mgTradjenta5/4/2015

Non-Orange Book Patents for Tradename: TRADJENTA

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
9,751,855Process 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
9,499,546Process 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
6,803,357 Method 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
7,820,815Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines► Subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► 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 Tradename: TRADJENTA

Country Document Number Estimated Expiration
European Patent Office1532149► Subscribe
South Africa200701996► Subscribe
Malaysia156243► Subscribe
Hong Kong1134077► Subscribe
Luxembourg92615► Subscribe
India1133DEN2015► Subscribe
Japan2010248253► Subscribe
Germany50312295► Subscribe
Luxembourg92612► Subscribe
Peru02352011► 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: TRADJENTA

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
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
C/GB14/086United Kingdom► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
1084705/04Switzerland► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
2014042Lithuania► SubscribePRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
2014 00066Denmark► SubscribePRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
382Luxembourg► Subscribe91382, EXPIRES: 20220424
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Moodys
Citi
Merck
Argus Health
UBS
Teva
QuintilesIMS
Chinese Patent Office

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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