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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, Hospira Inc, Mylan Institutional, Eagle Pharms, Sandoz, Hikma Pharm Co Ltd, Par Sterile Products, Teva Pharms Usa, and Pfizer, and is included in ten 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 eleven drug master file entries for argatroban. Eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: argatroban

Tradenames:4
Patents:2
Applicants:9
NDAs:10
Drug Master File Entries: see list11
Suppliers / Packagers: see list8
Bulk Api Vendors: see list92
Clinical Trials: see list5
Patent Applications: see list4,206
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:argatroban at DailyMed

Pharmacology for Ingredient: argatroban

Tentative approvals for ARGATROBAN

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION250MG/250ML
<disabled><disabled>INJECTABLE; INJECTION100MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)022434-001Jun 29, 2011RXYesYes7,589,106► subscribeY ► subscribe
Fresenius Kabi Usa
ARGATROBAN
argatroban
INJECTABLE;INJECTION201811-001Mar 23, 2015RXNoNo► subscribe► subscribe
Par Sterile Products
ARGATROBAN
argatroban
INJECTABLE;INJECTION091665-001Jun 30, 2014RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: argatroban

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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International Patent Family for Ingredient: argatroban

Country Document Number Estimated Expiration
European Patent Office2083823► subscribe
Canada2669727► subscribe
World Intellectual Property Organization (WIPO)2008039473► subscribe
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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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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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