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ARGATROBAN Drug Profile

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Which patents cover Argatroban, and when can generic versions of Argatroban launch?

Argatroban is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis Pharms Corp, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd. and is included in twelve NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

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

Summary for ARGATROBAN

US Patents:	0
Applicants:	11
NDAs:	12
Suppliers / Packagers:	8
Bulk Api Vendors:	104
Clinical Trials:	19
Patent Applications:	12
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARGATROBAN
DailyMed Link:	ARGATROBAN at DailyMed

Pharmacology for ARGATROBAN

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

Synonyms for ARGATROBAN

(2R,4R)-1-((2S)-5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydroquinoline-8-sulfonamido)pentanoyl)-4-methy

(2R,4R)-1-((2S)-5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydroquinoline-8-sulfonamido)pentanoyl)-4-methylpiperidine-2-carboxylic acid

(2R,4R)-1-((S)-5-(diaminomethyleneamino)-2-(3-methyl-1,2,3,4-tetrahydroquinoline-8-sulfonamido)pentanoyl)-4-methylpiperidine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]-1-oxopentyl]-4-methyl-2-piperidinecarboxylic acid

(2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid hydrate

(2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[[(3R)-3-methyl-1,2,3,4-tetrahydroquinolin-8-yl]sulfonylamino]pentanoyl]-4-methyl-pipe ridine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[[(3R)-3-methyl-1,2,3,4-tetrahydroquinolin-8-yl]sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-(diaminomethylideneamino)-2-[[(3S)-3-methyl-1,2,3,4-tetrahydroquinolin-8-yl]sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-[(Aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2-piperidinecarboxylic Acid

(2R,4R)-1-[(2S)-5-carbamimidamido-2-(3-methyl-1,2,3,4-tetrahydroquinoline-8-sulfonamido)pentanoyl]-4-methylpiperidine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-carbamimidamido-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid;hydrate

(2R,4R)-1-[(2S)-5-guanidino-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methyl-piperidine-2-carboxylic acid

(2R,4R)-1-[(2S)-5-guanidino-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methyl-piperidine-2-carboxylic acid hydrate

(2R,4R)-1-[(S)-5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid

(2R,4R)-1-[5-(diaminomethylideneamino)-2-[(3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonylamino]pentanoyl]-4-methylpiperidine-2-carboxylic acid

(2R,4R)-4-methyl-1-(((3-methyl-1,2,3,4-tetrahydroquinolin-8-yl)sulfonyl)-L-arginyl)piperidine-2-carboxylic acid hydrate

(2R,4R)-4-Methyl-1-((S)-N(sup 2)-(((RS)-1,2,3,4-tetrahydro-3-methyl-8-quinolyl)sulfonyl)arginyl)pipecolic acid

(2R,4R)-4-Methyl-1-(N(sup 2)-((1,2,3,4-tetrahydro-3-methyl-8-quinolyl)sulfonyl)-L-arginyl)pipecolic acid, monohydrate

(2R,4R)-4-Methyl-1-[N-[(3-methyl-1,2,3,4-tetrahydro-8-quinolinyl)sulfonyl]-L-arginyl]-2-piperidinecarboxylic acid

(2r,4r)-4-methyl-1-[n2-(3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-l-arginyl]-2-piperidinecarboxylic acid

(2R,4R)-4-Methyl-1-[Nalpha-[(3-methyl-1,2,3,4-tetrahydro-8-quinolinyl)sulfonyl]-L-arginyl]-2-piperidinecarboxylic acid

(2R,4R)-4-Methyl-1[Nalpha-[(3-methyl-1,2,3,4-tetrahydro-8-quinolinyl)sulfonyl]-L-arginyl)]-2-piperadinecarboxylic acid

(2R,4S)-1-[5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid

(2S,4S)-1-[5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid

(S)-1-[5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid

1-[(2R,3S)-5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid

1-[5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid

1-[5-Guanidino-2-(3-methyl-1,2,3,4-tetrahydro-quinoline-8-sulfonylamino)-pentanoyl]-4-methyl-piperidine-2-carboxylic acid (Argatroban)

121785-71-5

141396-28-3

2-Piperidinecarboxylic acid, 1-((2S)-5-((aminoiminomethyl)amino)-1-oxo-2-(((1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl)amino)pentyl)-4-methyl-, (2R,4R)-

2-Piperidinecarboxylic acid, 1-(5-((aminoiminomethyl)amino)-1-oxo-2-(((1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl)amino)pentyl)-4-methyl-

2-Piperidinecarboxylic acid, 1-(5-((aminoiminomethyl)amino)-1-oxo-2-(((1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl)amino)pentyl)-4-methyl-, monohydrate

2-Piperidinecarboxylic acid, 1-(5-((aminoiminomethyl)amino)-1-oxo-2-(((1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl)amino)pentyl)methyl-, monohydrate, (2R-((2S*),2-alpha,4-beta))-

2-Piperidinecarboxylic acid, 1-[(2S)-5-[(aminoiminomethyl)amino]-1-oxo-2-[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-, (2R,4R)-

21R-Argatroban

2858AH

3449AH

4-methyl-1-(N(2)-(3-methyl-1,2,3,4-tetrahydro-8-quinolinesulfonyl)-L-arginyl)-2-piperidinecarboxylic acid

74863-84-6

748A846

863A846

AB0007376

AB00639932-04

AB01275532_02

AB01275532-01

AB1009241

AC1L3OP7

AC1L3OPA

AC1Q5QXC

Acova

AIEZTKLTLCMZIA-CZSXTPSTSA-N

AK-64342

AK198584

AKOS015919612

AKOS026673901

AN-453

ANW-47142

Argatra

Argatroban (anhydrous)

Argatroban (monohydrate)

Argatroban (USAN)

Argatroban [INN:JAN]

Argatroban [USAN:INN:BAN:JAN]

Argatroban [USAN]

Argatroban anhydrous

Argatroban hydrate

Argatroban hydrate (JP17)

Argatroban In Sodium Chloride

Argatroban Injection

Argatroban monohydrate

argatroban sodium

Argatrobanum

Argatrobanum [Latin]

Argipidine

AS-14191

AT-20554

AT-21034

AX8212071

BDBM50038001

BR-64342

C23H36N6O5S

C23H36N6O5S.H2O

CA0140

CCG-100933

CCG-207885

CHEBI:94385

CHEMBL1166

CPD000466348

CS-2441

CS-4257

CTK8B5034

D00181

D07UWV

DK 7419

DK-7419

Exembol

FT-0602870

FT-0770947

GN 1600

GN-1600

GN1600

GTPL6385

HMS2051N07

HMS2090L12

HY-B0375

HY-B0375A

J-500992

J-500996

K280

KS-00000FNV

KXNPVXPOPUZYGB-IOVMHBDKSA-N

LS-114621

LS-114622

MCI 9038

MCI-9038

MD 805

MD-805

MD805

MDI-805

MFCD00895735

MITSUBISHI INHIBITOR

MLS000759461

MLS001424093

MLS006010033

MMTQAP

MolPort-006-069-116

MolPort-039-139-553

MolPort-042-652-601

MolPort-044-559-874

MPQA

MQI-ARG-MCP

MQPA

NC00183

NCGC00166413-01

NCGC00166413-03

Novastan

Novastan (TN)

OM 805

OM-805

Q-101034

RL04842

S-7070

s2069

SAM001246661

SC-17314

SC-66357

SCHEMBL1145308

SCHEMBL3447908

Slonnon

SMR000466348

SMR004624627

SR-05000001529

SR-05000001529-2

ST24024606

TC-135887

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
Amneal Pharms Co	ARGATROBAN	argatroban	INJECTABLE;INJECTION	206698-001	Jan 26, 2018	AP	RX	No	No
Novartis Pharms Corp	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000	AP	RX	Yes	Yes
Hikma Pharm Co Ltd	ARGATROBAN	argatroban	INJECTABLE;INJECTION	203049-001	Jan 5, 2012	AP	RX	No	No
Eagle Pharms	ARGATROBAN IN SODIUM CHLORIDE	argatroban	INJECTABLE;IV (INFUSION)	022434-001	Jun 29, 2011		RX	Yes	Yes			Y

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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
Novartis Pharms Corp	ARGATROBAN	argatroban	INJECTABLE;INJECTION	020883-001	Jun 30, 2000

Paragraph IV (Patent) Challenges for ARGATROBAN

Drugname	Dosage	Strength	RLD	Submissiondate
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24

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