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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.
A generic version of LINAGLIPTIN was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.
Summary for LINAGLIPTIN
Recent Clinical Trials for LINAGLIPTIN
Identify potential brand extensions & 505(b)(2) entrants
|Wuxi People's Hospital||N/A|
|The First Affiliated Hospital with Nanjing Medical University||N/A|
|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School||N/A|
Medical Subject Heading (MeSH) Categories 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|
|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.
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|