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Last Updated: October 7, 2022

LINAGLIPTIN Drug Patent Profile


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When do Linagliptin patents expire, and when can generic versions of Linagliptin launch?

Linagliptin is a drug marketed by Sunshine and is included in two NDAs.

The generic ingredient in LINAGLIPTIN is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

Drug patent expirations by year for LINAGLIPTIN
Recent Clinical Trials for LINAGLIPTIN

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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

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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
Sunshine LINAGLIPTIN linagliptin TABLET;ORAL 208335-001 Aug 31, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-002 Aug 30, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunshine LINAGLIPTIN AND METFORMIN HYDROCHLORIDE linagliptin; metformin hydrochloride TABLET;ORAL 208336-003 Aug 30, 2021 AB RX No No See Plans and Pricing See Plans and Pricing 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

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

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
McKesson
Boehringer Ingelheim
Express Scripts
Baxter

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