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Last Updated: August 8, 2020

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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. Twelve 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
Weill Medical College of Cornell UniversityPhase 4
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Hui-Sheng ChenN/A

See all argatroban clinical trials

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
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
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
Aurobindo Pharma Ltd ARGATROBAN IN SODIUM CHLORIDE argatroban SOLUTION;INTRAVENOUS 209552-001 Nov 27, 2018 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
Mylan Institutional ARGATROBAN argatroban INJECTABLE;INJECTION 202626-001 Jun 30, 2014 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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