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Argatroban - Generic Drug Details

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Argatroban is the generic ingredient in four branded drugs marketed by Fresenius Kabi Usa, Mylan Institutional, Eagle Pharms, Sandoz, Hikma Pharm Co Ltd, Par Sterile Products, Teva Pharms Usa, and Pfizer, and is included in nine NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seven patent family members in five countries.

There are ten drug master file entries for argatroban. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: argatroban

Tradenames:4
Patents:2
Applicants:8
NDAs:9
Drug Master File Entries: see list10
Suppliers / Packaging: see list7
Formulation / Manufacturing:see details

Tentative approvals for ARGATROBAN

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION250MG/250ML
<disabled><disabled>INJECTABLE; INJECTION100MG

Clinical Trials for: argatroban

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharm Co Ltd
ARGATROBAN
argatroban
INJECTABLE;INJECTION203049-001Jan 5, 2012RXNo<disabled><disabled>
Fresenius Kabi Usa
ARGATROBAN
argatroban
INJECTABLE;INJECTION201811-001Mar 23, 2015RXNo<disabled><disabled>
Teva Pharms Usa
ARGATROBAN IN 0.9% SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)206769-001Dec 15, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: 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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International Patent Family for Ingredient: argatroban

Country Document Number Estimated Expiration
China101516370<disabled in preview>
World Intellectual Property Organization (WIPO)2008039473<disabled in preview>
Japan2010504971<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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