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Generated: June 20, 2018

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ARGATROBAN - Generic Drug Details

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

Argatroban
is the generic ingredient in four branded drugs 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, Eagle Pharms, Gland Pharma Ltd, and Sandoz, and is included in twelve 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.
Pharmacology for ARGATROBAN
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
Tentative approvals for ARGATROBAN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial250MG/250MLINJECTABLE; INJECTION
➤ Try a Free Trial➤ Try a Free Trial100MGINJECTABLE; 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
Hospira Inc ARGATROBAN argatroban INJECTABLE;INJECTION 204120-001 Sep 21, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa ARGATROBAN IN 0.9% SODIUM CHLORIDE argatroban INJECTABLE;IV (INFUSION) 206769-001 Dec 15, 2014 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-001 Jan 5, 2012 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-002 Sep 30, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp ARGATROBAN argatroban INJECTABLE;INJECTION 020883-001 Jun 30, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Farmers Insurance
UBS
Harvard Business School
Citi
Federal Trade Commission
Fuji
Express Scripts
US Army

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