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Details for Generic Name: argatroban

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Argatroban is the generic ingredient in four branded drugs marketed by Fresenius Kabi Usa, Hikma Pharm Co Ltd, Mylan Institutional, Par Sterile Products, Pfizer, Teva Pharms Usa, Eagle Pharms, and Sandoz, and is included in nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seven patent family members in five countries.

There are ten drug master file entries for argatroban. Six suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: argatroban

Drug Master File Entries: see list10
Suppliers / Packaging: see list10

Pharmacology for Ingredient: argatroban

Tentative approvals for ARGATROBAN

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION250MG/250ML
<disabled><disabled>INJECTABLE; INJECTION100MG

Clinical Trials for: argatroban

Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting
Status: Recruiting Condition: CVD

Randomized Controlled Trial of Argatroban With Tissue Plasminogen Activator (tPA) for Acute Stroke
Status: Terminated Condition: Ischemic Stroke

Safety and Feasibility of Argatroban, Tissue Plasminogen Activator and Intra-arterial Therapy in Stroke
Status: Recruiting Condition: Stroke; Cerebral Ischemia

Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting
Status: Completed Condition: CVD

Argatroban Versus Lepirudin in Critically Ill Patients
Status: Terminated Condition: Heparin Induced Thrombocytopenia (HIT)

Argatroban Stroke Treatment - A Pilot Safety Study
Status: Completed Condition: Ischemic Stroke

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional
INJECTABLE;INJECTION202626-001Jun 30, 2014RXNo<disabled><disabled>
Eagle Pharms
INJECTABLE;IV (INFUSION)022434-001Jun 29, 2011RXYes7,589,106<disabled>Y <disabled>
SOLUTION;IV (INFUSION)201743-001May 9, 2011DISCNNo<disabled><disabled>
Par Sterile Products
INJECTABLE;INJECTION091665-001Jun 30, 2014RXNo<disabled><disabled>
INJECTABLE;INJECTION020883-001Jun 30, 2000RXYes<disabled><disabled>
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International Patent Family for Ingredient: argatroban

Country Document Number Publication Date
Canada2669727Apr 03, 2008
World Intellectual Property Organization (WIPO)2008045410Jun 12, 2008
Japan5624766Nov 12, 2014
World Intellectual Property Organization (WIPO)2008039473Apr 03, 2008
European Patent Office2083823Jan 13, 2010
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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