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Serving leading biopharmaceutical companies globally:

Cipla
Merck
McKinsey
Queensland Health
Fuji
UBS
Daiichi Sankyo
Citi
Novartis
Baxter

Generated: February 24, 2018

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 sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Linagliptin has two hundred and ninety-nine patent family members in forty-four countries.

There are seventeen drug master file entries for linagliptin. Two suppliers are listed for this compound.
Summary for linagliptin
Pharmacology for linagliptin
Medical Subject Heading (MeSH) Categories for linagliptin

US Patents and Regulatory Information for linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
6,803,357 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
8,664,232 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions ➤ Try a Free Trial
7,820,815 Process for the preparation of chiral 8-(-3-aminopiperidin-1-yl) xanthines ➤ Try a Free Trial
8,318,669 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
9,108,964 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions ➤ Try a Free Trial
8,513,190 Method of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
9,499,546 Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines ➤ Try a Free Trial
9,556,175 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and thier use as pharmaceutical compositions ➤ Try a Free Trial
9,044,424 Methods of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
9,321,791 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for linagliptin

Supplementary Protection Certificates for linagliptin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00708 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
2012022 Lithuania ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
2011 00030 Denmark ➤ Try a Free Trial
C/GB14/084 United Kingdom ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
00569 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
90035-4 Sweden ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTIN, DESS ENANTIOMERER OCH SALTER DAERAV; REG. NO/DATE: EU/1/11/707/001 20110824
2014 00065 Denmark ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
C0052 France ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110824
2011013,C1532149 Lithuania ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082
2011 00030 Denmark ➤ Try a Free Trial PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Daiichi Sankyo
Julphar
Mallinckrodt
Harvard Business School
Boehringer Ingelheim
Citi
Healthtrust

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