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ARGATROBAN Drug Profile

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Argatroban is a drug marketed by Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Hikma Pharm Co Ltd, Par Sterile Products, Pfizer, Teva Pharms Usa, Sandoz, and Eagle Pharms. and is included in ten 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:9
NDAs:10
Suppliers / Packagers: see list4
Drug Prices: :see details
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► subscribe► subscribe
Teva Pharms Usa
ARGATROBAN IN 0.9% SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)206769-001Dec 15, 2014RXNo► subscribe► subscribe
Hikma Pharm Co Ltd
ARGATROBAN
argatroban
INJECTABLE;INJECTION203049-001Jan 5, 2012RXNo► subscribe► subscribe
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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► subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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