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ARGATROBAN Drug Profile

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Argatroban is a drug marketed by Fresenius Kabi Usa, Mylan Institutional, Hikma Pharm Co Ltd, Par Sterile Products, Pfizer, Teva Pharms Usa, Sandoz, and Eagle Pharms. and is included in nine NDAs. It is available from four suppliers. 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. Seven 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:2
Applicants:8
NDAs:9
Suppliers / Packagers: see list4

Clinical Trials for: ARGATROBAN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
ARGATROBAN
argatroban
INJECTABLE;INJECTION201811-001Mar 23, 2015RXNo<disabled><disabled>
Sandoz
ARGATROBAN IN DEXTROSE
argatroban
SOLUTION;IV (INFUSION)201743-001May 9, 2011DISCNNo<disabled><disabled>
Par Sterile Products
ARGATROBAN
argatroban
INJECTABLE;INJECTION091665-001Jun 30, 2014RXNo<disabled><disabled>
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Expired Patents for Tradename: ARGATROBAN

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
ARGATROBAN
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 20005,214,052<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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