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Last Updated: March 29, 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, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Pharm Co Ltd, Hospira, Mylan Institutional, Par Sterile Products, 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
⤷  Try a Trial⤷  Try a Trial250MG/250MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a 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
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
Gland Pharma Ltd ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 205570-001 May 22, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa ARGATROBAN IN 0.9% SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 206769-001 Dec 15, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Sterile Products ARGATROBAN argatroban INJECTABLE;INJECTION 091665-001 Jun 30, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms Co ARGATROBAN argatroban INJECTABLE;INJECTION 206698-001 Jan 26, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022485-001 May 9, 2011 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional ARGATROBAN argatroban INJECTABLE;INJECTION 202626-001 Jun 30, 2014 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-001 Jan 5, 2012 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Canada 2669727 PREPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008039473 ⤷  Try a Trial
Japan 2010504971 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008045410 ⤷  Try a Trial
European Patent Office 2083823 PRÉPARATION SANS ALCOOL D'ARGATROPAN (ALCOHOL FREE FORMULATION OF ARGATROBAN) ⤷  Try a Trial
China 101516370 Alcohol free formulation of argatroban ⤷  Try a Trial
Japan 5624766 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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