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Profile for Tradename: ARGATROBAN

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Argatroban is a drug marketed by Fresenius Kabi Usa, Hikma Pharm Co Ltd, Mylan Institutional, Par Sterile Products, Pfizer, Teva Pharms Usa, Sandoz, and Eagle Pharms. and is included in nine NDAs. It is available from three 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. Six 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 / Packagers: see list4

Pharmacology for Tradename: ARGATROBAN

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
INJECTABLE;INJECTION201811-001Mar 23, 2015RXNo<disabled><disabled>
SOLUTION;IV (INFUSION)201743-001May 9, 2011DISCNNo<disabled><disabled>
Par Sterile Products
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
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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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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