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Last Updated: December 11, 2019

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Argatroban - Generic Drug Details

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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, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis, Par Sterile Products, Teva Pharms Usa, Eagle Pharms, Gland Pharma Ltd, Sandoz, and Aurobindo Pharma Ltd, and is included in thirteen 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. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for argatroban

See drug prices for argatroban

Recent Clinical Trials for argatroban

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

SponsorPhase
Aspen Global IncorporatedPhase 3
National Institute of Neurological Disorders and Stroke (NINDS)Phase 3
University of CincinnatiPhase 3

See all argatroban clinical trials

Recent Litigation for argatroban

Identify potential future generic entrants

District Court Litigation
Case NameDate
EAGLE PHARMACEUTICALS, INC. v. ACCORD HEALTHCARE, INC.2019-03-27
Mitsubishi Chemical Corporation v. Barr Laboratories, Inc.2007-12-28
GLAXOSMITHKLINE PLC v. HIKMA PHARMACEUTICAL CO., LTD.

See all argatroban litigation

Generic filers with tentative approvals for ARGATROBAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial250MG/250MLINJECTABLE; INJECTION
  Start Trial  Start Trial100MGINJECTABLE; 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
Synonyms for argatroban
(21R)-Argatroban
(2R,4R)-1-((2S)-5-guanidino-2-(3-methyl-1,2,3,4-tetrahydroquinoline
(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-[(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)-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,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))-
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
Argatrobanum
Argatrobanum [Latin]
Argipidine
AS-14191
AT-20554
AT-21034
AX8212071
BCP06831
BCP09304
BDBM50038001
BR-64342
BRD-A48261811-001-08-1
C23H36N6O5S
C23H36N6O5S.H2O
CA0140
CCG-100933
CCG-207885
CHEBI:94385
CHEMBL1166
CPD000466348
CS-2441
CS-4257
CTK8B5034
D00181
DK 7419
DK-7419
Exembol
FT-0602870
FT-0770947
GN 1600
GN-1600
GN1600
GTPL6385
HMS2051N07
HMS2090L12
HMS3713D22
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
MLS000759461
MLS001424093
MLS006010033
MMTQAP
MolPort-006-069-116
MolPort-039-139-553
MolPort-042-652-601
MPQA
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
SCHEMBL20567702
SCHEMBL3447908
Slonnon
SMR000466348
SMR004624627
SR-01000759392
SR-01000759392-4
SR-05000001529
SR-05000001529-1
SR-05000001529-2
ST24024606
TC-135887
Paragraph IV (Patent) Challenges for ARGATROBAN
Tradename Dosage Ingredient NDA Submissiondate
ARGATROBAN IN SODIUM CHLORIDE INJECTABLE;INTRAVENOUS argatroban 022434 2011-12-16
ARGATROBAN INJECTABLE;INJECTION argatroban 020883 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
Amneal Pharms Co ARGATROBAN argatroban INJECTABLE;INJECTION 206698-001 Jan 26, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Eagle Pharms ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022434-001 Jun 29, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sandoz ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022485-001 May 9, 2011 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ARGATROBAN IN SODIUM CHLORIDE argatroban SOLUTION;INTRAVENOUS 209552-001 Nov 27, 2018 RX No No   Start Trial   Start Trial   Start Trial
Novartis ARGATROBAN argatroban INJECTABLE;INJECTION 020883-001 Jun 30, 2000 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 205570-001 May 22, 2017 AP RX No No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Baxter
Mallinckrodt
Merck
AstraZeneca

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