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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Covington
AstraZeneca
Johnson and Johnson
QuintilesIMS
US Department of Justice
Farmers Insurance
Medtronic
US Army
Mallinckrodt

Generated: January 16, 2018

DrugPatentWatch Database Preview

Argatroban - Generic Drug Details

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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, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis Pharms Corp, Par Sterile Products, Teva Pharms Usa, Eagle Pharms, Gland Pharma Ltd, and Sandoz, 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. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for argatroban
Tentative approvals for ARGATROBAN
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe250MG/250MLINJECTABLE; INJECTION
➤ Subscribe➤ Subscribe100MGINJECTABLE; INJECTION

US Patents and Regulatory Information for argatroban

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products ARGATROBAN argatroban INJECTABLE;INJECTION 091665-001 Jun 30, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Eagle Pharms ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;IV (INFUSION) 022434-001 Jun 29, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-001 Jan 5, 2012 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gland Pharma Ltd ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;IV (INFUSION) 205570-001 May 22, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Institutional ARGATROBAN argatroban INJECTABLE;INJECTION 202626-001 Jun 30, 2014 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-002 Sep 30, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ARGATROBAN argatroban INJECTABLE;INJECTION 020883-001 Jun 30, 2000 AP RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz ARGATROBAN IN DEXTROSE argatroban SOLUTION;IV (INFUSION) 201743-001 May 9, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hospira Inc ARGATROBAN argatroban INJECTABLE;INJECTION 204120-001 Sep 21, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Pharms Usa ARGATROBAN IN 0.9% SODIUM CHLORIDE argatroban INJECTABLE;IV (INFUSION) 206769-001 Dec 15, 2014 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for argatroban

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp ARGATROBAN argatroban INJECTABLE;INJECTION 020883-001 Jun 30, 2000 ➤ Subscribe ➤ Subscribe
Novartis Pharms Corp ARGATROBAN argatroban INJECTABLE;INJECTION 020883-001 Jun 30, 2000 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for argatroban

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Serving leading biopharmaceutical companies globally:

Deloitte
US Army
QuintilesIMS
AstraZeneca
Cantor Fitzgerald
Queensland Health
McKesson
Healthtrust
Chinese Patent Office

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