Argatroban - Generic Drug Details

What are the generic sources for argatroban and what is the scope of patent protection?

Argatroban is the generic ingredient in four branded drugs marketed by Amneal Pharms Co, Caplin, Fresenius Kabi Usa, Gland, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Ph Health, Sandoz, Teva Pharms Usa, Cipla, Plano Pharms, Accord Hlthcare, and Eugia Pharma Speclts, and is included in sixteen 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. Twelve suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for argatroban

International Patents:	7
US Patents:	2
Tradenames:	4
Applicants:	14
NDAs:	16
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	35
Drug Prices:	Drug price trends 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

See drug prices for argatroban

Recent Clinical Trials for argatroban

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

Sponsor	Phase
Medical University of Vienna	PHASE4
Veralox Therapeutics	Phase 2
Veralox Therapeutics	Phase 1

See all argatroban clinical trials

Generic filers with tentative approvals for ARGATROBAN

Applicant	Application No.	Strength	Dosage Form
		250MG/250ML	INJECTABLE; INJECTION
		100MG	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for argatroban

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

Anatomical Therapeutic Chemical (ATC) Classes for argatroban

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

Paragraph IV (Patent) Challenges for ARGATROBAN

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

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
Caplin	ARGATROBAN	argatroban	INJECTABLE;INJECTION	214235-001	Jan 21, 2021	AP	RX	No	No
Gland	ARGATROBAN	argatroban	INJECTABLE;INJECTION	217848-001	Jul 31, 2023	AP	RX	No	No
Cipla	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	022434-001	Jun 29, 2011		DISCN	Yes	No	7,589,106		Y
Teva Pharms Usa	ARGATROBAN IN 0.9% SODIUM CHLORIDE	argatroban	INJECTABLE;INTRAVENOUS	206769-001	Dec 15, 2014		DISCN	No	No

Expired US Patents for argatroban

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	5,214,052
Sandoz	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	5,925,760

International Patents for argatroban

Country	Patent Number	Title	Estimated Expiration
Canada	2669727	PREPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)
China	101516370	Alcohol free formulation of argatroban
European Patent Office	2083823	PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN)
Japan	2010504971	アルコールを含まないアルガトロバン製剤