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TRADJENTA Drug Profile

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Which patents cover Tradjenta, and what substitute generic drugs 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 twenty-four patent family members in forty-five countries.

The generic ingredient in TRADJENTA is linagliptin. There are sixteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

Summary for Tradename: TRADJENTA

Patents:13
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list46
Clinical Trials: see list7
Patent Applications: see list137
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TRADJENTA at DailyMed

Pharmacology for Tradename: TRADJENTA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes6,303,661► Subscribe ► Subscribe
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes8,853,156► Subscribe ► Subscribe
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes7,459,428► Subscribe ► Subscribe
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes9,486,526► Subscribe ► Subscribe
Boehringer Ingelheim
TRADJENTA
linagliptin
TABLET;ORAL201280-001May 2, 2011RXYesYes8,673,927► Subscribe ► Subscribe
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Paragraph IV activity 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
9,499,546Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines► Subscribe
6,803,357 Method 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
7,820,815Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines► 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
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: TRADJENTA

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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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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