Viewing data from:

ARGATROBAN IN SODIUM CHLORIDE

NDA

ARGATROBAN | N022485 | PLANO PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Eugia US, LLC FDA-2022-P-2498 · 3 docket documents Eugia US LLC, the U.S. agent for Eugia Pharma Specialities Limited, filed this petition requesting that the FDA assign a therapeutic equivalence rating of 'AP' to Eugia's Argatroban in Sodium Chloride Injection, 50 mg/50 mL, approved under 505(b)(2) NDA 209552, when compared to the reference listed	Other	2022-10-12	Open	Eugia US, LLC
Citizen Petition from AuroMedics Pharma LLC FDA-2019-P-2687 · 4 docket documents AuroMedics Pharma LLC, the U.S. agent for Aurobindo Pharma Limited, filed this citizen petition on June 3, 2019, requesting that the FDA assign a therapeutic equivalence rating of AP to Aurobindo's Argatroban in Sodium Chloride Injection, 50 mg/50 mL, approved under 505(b)(2) NDA 209552, relative to	505(q)	2019-06-04	Withdrawn	AuroMedics Pharma LLC
Suitability Petition from Comodo Health, Inc. FDA-2015-P-2736 · 3 docket documents Comodo Health, Inc. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that FDA determine the suitability of Argatroban in Sodium Chloride Injectable for intravenous use in three different vial fill sizes (25 mg/25 mL, 50 mg/50 mL, and 100 mg/100 mL) compared to the reference lis	Suitability	2015-08-04	Open	Comodo Health, Inc.
Citizen Petition From Lachman Consultant Services, Inc. FDA-2014-P-0813 · 7 docket documents Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Argatroban Injection, 1 mg/mL in a 50 mg/50 mL strength suitable for submission in an ANDA, based on the Sandoz listed drug Argatr	Other	2014-06-23	Withdrawn	Lachman Consultant Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

23 trials from ClinicalTrials.gov, 16 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Argatroban in Critically Ill Patients With Heparin Resistance NCT01734252	Phase 2	Completed	Medical University Innsbruck	44	2012-07-29 → 2016-04-01
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II NCT00861692	Phase 2	Completed	Tanabe Pharma Corporation	20	2009-04 → 2011-02
Efficacy and Safety Study of Argatroban to Treat Heparin-Induced Thrombocytopenia NCT00198588	Phase 3	Completed	Ministry of Health, Labour and Welfare, Japan	8	2005-06 → 2006-09
Study on Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Percutaneous Coronary Intervention (PCI)NCT00508924	Phase 2	Completed	Tanabe Pharma Corporation	140	2005-08 → 2006-10
Argatroban for Preventing Occlusion and Restenosis After Extracranial Vertebral Artery Stenting NCT01980316	Phase 4	Completed	Xinfeng Liu	114	2010-04 → 2013-07
Thromboprophylaxis After Surgery for Gynecologic Malignancy in China NCT02935530	Phase 3	Completed	Huazhong University of Science and Technology	315	2016-01 → 2017-10
Argatroban Stroke Treatment - A Pilot Safety Study NCT00268762	Phase 1/2	Completed	The University of Texas Health Science Center, Houston	65	2003-02 → 2010-08
Argatroban for Preventing Occlusion and Restenosis After Intracranial and Extracranial Artery Stenting NCT01163604	Phase 4	Completed	Jinling Hospital, China	114	2010-08 → 2014-08
Efficacy Argatroban in Ischemic Stroke With Early Deterioration (EASE)NCT04275180	Phase 4	Completed	Second Affiliated Hospital, School of Medicine, Zhejiang University	628	2020-03-21 → 2023-01-31
Direct Thrombin Inhibitors Versus LMWH in Staphylococcus Aureus Bacteraemia NCT01911624	Phase 2	Completed	Universitaire Ziekenhuizen KU Leuven	94	2013-01 → 2016-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain10 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

CHEMWERTH INCARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE

DMF 207092007

CURIA ITALY SRLARGATROBAN

DMF 207602007

LUNDBECK PHARMACEUTICALS ITALY SPAARGATROBAN

DMF 213042008

GLAND PHARMA LTDARGATROBAN MONOHYDRATE USP

DMF 254002011

EMCURE PHARMACEUTICALS LTDARGATROBAN USP

DMF 257652012

ALP PHARM BEIJING CO LTDARGATROBAN HYDRATE

DMF 258932012

GLAND PHARMA LTDARGATROBAN MONOHYDRATE (PROCESS-II)

DMF 280302014

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDARGATROBAN

DMF 354912020

CURIA ITALY SRLARGATROBAN MONOHYDRATE

DMF 402272024

SUZHOU RYWAY BIOTECH CO LTDARGATROBAN

DMF 424262025

SCINOPHARM TAIWAN LTDInactiveARGATROBAN

DMF 229352009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 30, 2019	SUPPL -13	View Letter (PDF)
Jul 6, 2018	SUPPL -11	View Letter (PDF)
May 27, 2016	SUPPL -9	View Letter (PDF)
May 12, 2011	ORIG -1	View Letter (PDF)
Jan 19, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 125MG/125ML (1MG/ML)

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: May 9, 2011

No patent or exclusivity listings for this strength.