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Last Updated: November 22, 2024

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, Caplin, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Sandoz, Teva Pharms Usa, Cipla, 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. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for ARGATROBAN

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Recent Clinical Trials for ARGATROBAN

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

SponsorPhase
Veralox TherapeuticsPhase 2
CelerionPhase 1
Veralox TherapeuticsPhase 1

See all ARGATROBAN clinical trials

Generic filers with tentative approvals for ARGATROBAN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up250MG/250MLINJECTABLE; INJECTION
⤷  Sign Up⤷  Sign Up100MGINJECTABLE; 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
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
Teva Pharms Usa ARGATROBAN IN 0.9% SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 206769-001 Dec 15, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare ARGATROBAN IN SODIUM CHLORIDE argatroban SOLUTION;INTRAVENOUS 212035-001 Jun 7, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma Speclts ARGATROBAN IN SODIUM CHLORIDE argatroban SOLUTION;INTRAVENOUS 209552-001 Nov 27, 2018 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa ARGATROBAN argatroban INJECTABLE;INJECTION 201811-001 Mar 23, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz ARGATROBAN IN DEXTROSE argatroban SOLUTION;INTRAVENOUS 201743-001 May 9, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022434-001 Jun 29, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ARGATROBAN

Country Patent Number Title Estimated Expiration
European Patent Office 2083823 PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) ⤷  Sign Up
Japan 2010504971 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2008045410 ⤷  Sign Up
China 101516370 Alcohol free formulation of argatroban ⤷  Sign Up
Canada 2669727 PREPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) ⤷  Sign Up
Japan 5624766 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.