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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, 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.

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

Patents:1
Applicants:1
NDAs:1
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)

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
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
ARGATROBAN
argatroban
INJECTABLE; INJECTION020883Jun 30, 2000RXYes5,214,052<disabled><disabled>
Pfizer
ARGATROBAN
argatroban
INJECTABLE; INJECTION020883Jun 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
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