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Last Updated: March 2, 2021

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ARGATROBAN Drug Profile

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When do Argatroban patents expire, and when can generic versions of Argatroban launch?

Argatroban is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, Gland Pharma Ltd, and Aurobindo Pharma Ltd. and is included in thirteen NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.

US ANDA Litigation and Generic Entry Outlook for Argatroban

A generic version of ARGATROBAN was approved as argatroban by NOVARTIS on June 30th, 2000.

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Drug patent expirations by year for ARGATROBAN
Drug Prices for ARGATROBAN

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Recent Clinical Trials for ARGATROBAN

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

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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
Amneal Pharms Co ARGATROBAN argatroban INJECTABLE;INJECTION 206698-001 Jan 26, 2018 AP 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
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-001 Jan 5, 2012 AP RX Yes Yes   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:

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