Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Cipla
Colorcon
McKesson
US Army
McKinsey
Covington
Chinese Patent Office
Chubb
Accenture
Dow

Generated: October 23, 2017

DrugPatentWatch Database Preview

Argatroban - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for argatroban and what is the scope of argatroban freedom to operate?

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, Gland Pharma Ltd, and Novartis Pharms Corp, and is included in eleven NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Argatroban has seven patent family members in five countries.

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

Summary for Generic Name: argatroban

US Patents:2
Tradenames:4
Applicants:10
NDAs:11
Drug Master File Entries: see list11
Suppliers / Packagers: see list9
Bulk Api Vendors: see list92
Clinical Trials: see list19
Patent Applications: see list5,188
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. Strength Dosage Form
u► Subscribe250MG/250MLINJECTABLE; INJECTION
u► Subscribe100MGINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Pharm Co Ltd
ARGATROBAN
argatroban
INJECTABLE;INJECTION203049-002Sep 30, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Mylan Institutional
ARGATROBAN
argatroban
INJECTABLE;INJECTION202626-001Jun 30, 2014APRXNoNo► Subscribe► Subscribe► Subscribe
Gland Pharma Ltd
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)205570-001May 22, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Pharm Co Ltd
ARGATROBAN
argatroban
INJECTABLE;INJECTION203049-001Jan 5, 2012APRXNoNo► Subscribe► Subscribe► Subscribe
Eagle Pharms
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)022434-001Jun 29, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Sandoz
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)022485-001May 9, 2011APRXYesYes► Subscribe► Subscribe► Subscribe
Eagle Pharms
ARGATROBAN IN SODIUM CHLORIDE
argatroban
INJECTABLE;IV (INFUSION)022434-001Jun 29, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Hospira Inc
ARGATROBAN
argatroban
INJECTABLE;INJECTION204120-001Sep 21, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
ARGATROBAN
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 2000APRXYesYes► Subscribe► Subscribe► Subscribe
Sandoz
ARGATROBAN IN DEXTROSE
argatroban
SOLUTION;IV (INFUSION)201743-001May 9, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: argatroban

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
ARGATROBAN
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 2000► Subscribe► Subscribe
Novartis Pharms Corp
ARGATROBAN
argatroban
INJECTABLE;INJECTION020883-001Jun 30, 2000► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: argatroban

Country Document Number Estimated Expiration
Japan5624766► Subscribe
China101516370► Subscribe
World Intellectual Property Organization (WIPO)2008039473► Subscribe
European Patent Office2083823► Subscribe
Japan2010504971► Subscribe
World Intellectual Property Organization (WIPO)2008045410► Subscribe
Canada2669727► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Harvard Business School
Colorcon
Queensland Health
Accenture
Merck
Chubb
Novartis
Healthtrust
QuintilesIMS

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot