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Last Updated: June 21, 2024

LINAGLIPTIN - Generic Drug Details


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

Linagliptin is the generic ingredient in five branded drugs marketed by Sunshine, Zydus Pharms, and Boehringer Ingelheim, and is included in seven NDAs. There are fifteen 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 fifty-nine patent family members in forty-five countries.

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

Recent Clinical Trials for LINAGLIPTIN

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

SponsorPhase
EMSPhase 3
Huashan HospitalPhase 3
The First Affiliated Hospital with Nanjing Medical UniversityN/A

See all LINAGLIPTIN clinical trials

Generic filers with tentative approvals for LINAGLIPTIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up2.5MG; 1GTABLET;ORAL
⤷  Sign Up⤷  Sign Up2.5MG; 850MGTABLET;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 JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
>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 2006503013 ⤷  Sign Up
China 107674077 8‑[3‑氨基‑哌啶‑1‑基]‑黄嘌呤化合物,其制备方法及作为药物制剂的用途 (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, PRODUCTION THEREOF AND USE OF SAME AS MEDICAMENTS) ⤷  Sign Up
Japan 2019055984 メトホルミン治療に不適切な患者における糖尿病の治療 (TREATMENT FOR DIABETES IN PATIENTS INAPPROPRIATE FOR METFORMIN THERAPY) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LINAGLIPTIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 CR 2011 00030 Denmark ⤷  Sign Up 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
1532149 PA2012022 Lithuania ⤷  Sign Up PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1730131 C01730131/03 Switzerland ⤷  Sign Up PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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