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Details for Generic Name: argatroban

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Argatroban is the generic ingredient in five branded drugs marketed by Pfizer, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Mylan Institutional, Par Sterile Products, 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

Tradenames:5
Patents:2
Applicants:8
NDAs:9
Drug Master File Entries: see list10
Suppliers: see list6
Formulation / Manufacturing:see details

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

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

Argatroban in Critically Ill Patients With Heparin Resistance
Status: Recruiting Condition: Achievement of a Sufficient Thrombosis Prohpylaxis in Clitically Ill Patients With Heparin Resistance

Courtesy of ClinicalTrials.org
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
Par Sterile Products
ARGATROBAN
argatroban
INJECTABLE;INJECTION091665-001Jun 30, 2014RXNo<disabled><disabled>
Hikma Pharm Co Ltd
ARGATROBAN
argatroban
INJECTABLE;INJECTION203049-001Jan 5, 2012RXNo<disabled><disabled>
Pfizer
ACOVA
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 2000RXYes<disabled><disabled>
Mylan Institutional
ARGATROBAN
argatroban
INJECTABLE;INJECTION202626-001Jun 30, 2014RXNo<disabled><disabled>
Teva Pharms Usa
ARGATROBAN IN 0.9% SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)206769-001Dec 15, 2014RXNo<disabled><disabled>
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International Patent Family for Ingredient: argatroban

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2008045410Jun 12, 2008
China101516370Aug 26, 2009
Canada2669727Apr 03, 2008
World Intellectual Property Organization (WIPO)2008045410Apr 17, 2008
Japan2010504971Feb 18, 2010
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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