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Profile for Tradename: ARGATROBAN

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Argatroban is a drug marketed by Hikma Pharm Co Ltd, Mylan Institutional, Par Sterile Products, Fresenius Kabi Usa, Teva Pharms Usa, Sandoz, and Eagle Pharms. and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has five patent family members in three countries.

The generic ingredient in ARGATROBAN is argatroban. There are ten drug master file entries for this compound. Four suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the argatroban profile page.

Summary for Tradename: ARGATROBAN

Suppliers: see list1

Pharmacology for Tradename: ARGATROBAN

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: Recruiting 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)

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
INJECTABLE; INJECTION020883-001Jun 30, 2000RXYes5,214,052<disabled><disabled>
INJECTABLE; INJECTION020883-001Jun 30, 2000RXYes<disabled><disabled>
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Paragraph IV activity for: ARGATROBAN

Drugname Dosage Strength RLD Submissiondate
argatroban in sodium chlorideInjection1 mg/mL, 50 mL vialsArgatroban12/16/2011
argatrobanInjection100 mg/mL, 2.5 mL vialsArgatroban9/24/2007

International Patent Family for Tradename: ARGATROBAN

Country Document Number Publication Date
Germany3866303Jan 02, 1992
European Patent Office0301970Feb 01, 1989
JapanH0576929Oct 25, 1993
Germany122005000056Feb 23, 2006
JapanS6431727Feb 02, 1989
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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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