ARGATROBAN Drug Patent Profile

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Argatroban is a drug marketed by Amneal Pharms Co, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Sandoz, Teva Pharms Usa, Cipla, Accord Hlthcare, and Eugia Pharma Speclts. and is included in sixteen NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.

A generic version of ARGATROBAN was approved as argatroban by HIKMA PHARM CO LTD on January 5^th, 2012.

US Patents:	0
Applicants:	13
NDAs:	16
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	34
Patent Applications:	101
Drug Prices:	Drug price information for ARGATROBAN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARGATROBAN
What excipients (inactive ingredients) are in ARGATROBAN?	ARGATROBAN excipients list
DailyMed Link:	ARGATROBAN at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Drug Class	Anti-coagulant Direct Thrombin Inhibitor
Mechanism of Action	Thrombin Inhibitors

B01AE	Direct thrombin inhibitors
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARGATROBAN IN SODIUM CHLORIDE	Injection	argatroban	1 mg/mL, 50 mL vials	022434	1	2011-12-16
ARGATROBAN	Injection	argatroban	100 mg/mL, 2.5 mL vials	020883	1	2007-09-24

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	ARGATROBAN	argatroban	INJECTABLE;INJECTION	206698-001	Jan 26, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma Speclts	ARGATROBAN IN SODIUM CHLORIDE	argatroban	SOLUTION;INTRAVENOUS	209552-001	Nov 27, 2018		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharm Co Ltd	ARGATROBAN	argatroban	INJECTABLE;INJECTION	203049-001	Jan 5, 2012	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	ARGATROBAN	argatroban	INJECTABLE;INJECTION	201811-001	Mar 23, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ARGATROBAN IN DEXTROSE	argatroban	SOLUTION;INTRAVENOUS	201743-001	May 9, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	⤷ Sign Up	⤷ Sign Up
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering ARGATROBAN around the world.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	0823430	Procédé pour la préparation de N2-arylsulfonyl-L-arginamides (Method for preparing n2-arylsulfonyl-l-argininamides)	⤷ Sign Up
European Patent Office	0301970	METHOD FOR DISSOLVING ARGININEAMIDES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM	⤷ Sign Up
Spain	2166937		⤷ Sign Up
Germany	69707603		⤷ Sign Up
Japan	H0576929		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration