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Last Updated: October 7, 2022

Linagliptin - Generic Drug Details


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What are the generic sources for linagliptin and what is the scope of freedom to operate?

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

There are nineteen drug master file entries for linagliptin. Two suppliers are listed for this compound. There are eight tentative approvals for this compound.

Recent Clinical Trials for linagliptin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wuxi People's HospitalN/A
The First Affiliated Hospital with Nanjing Medical UniversityN/A
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolN/A

See all linagliptin clinical trials

Generic filers with tentative approvals for LINAGLIPTIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing5MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing2.5MG; 850MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing2.5MG; 500MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for linagliptin
Medical Subject Heading (MeSH) Categories for linagliptin
Paragraph IV (Patent) Challenges for LINAGLIPTIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRADJENTA Tablets linagliptin 5 mg 201280 11 2015-05-04

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 TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for linagliptin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for linagliptin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Trajenta linagliptin EMEA/H/C/002110
Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Authorised no no no 2011-08-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for linagliptin

Country Patent Number Title Estimated Expiration
Japan 5734564 See Plans and Pricing
Germany 10312353 8-[3-Amino-piperidin-1-yl]-xanthine, deren Herstellung und deren Verwendung als Arzneimittel (New 8-(3-amino-piperidin-1-yl)-xanthine derivatives are dipeptidylpeptidase-IV inhibitors useful for, e.g. treating diabetes mellitus, arthritis or obesity) See Plans and Pricing
Slovenia 2283819 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for linagliptin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 PA2011013 Lithuania See Plans and Pricing 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
2187879 1790019-2 Sweden See Plans and Pricing PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
1532149 PA2011013,C1532149 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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