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Last Updated: August 6, 2020

DrugPatentWatch Database Preview

ARGATROBAN IN SODIUM CHLORIDE Drug Profile

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Which patents cover Argatroban In Sodium Chloride, and what generic alternatives are available?

Argatroban In Sodium Chloride is a drug marketed by Eagle Pharms, Gland Pharma Ltd, Sandoz, and Aurobindo Pharma Ltd. and is included in four NDAs. There are two patents protecting this drug.

This drug has seven patent family members in five countries.

The generic ingredient in ARGATROBAN IN SODIUM CHLORIDE 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 In Sodium Chloride

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

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Drug patent expirations by year for ARGATROBAN IN SODIUM CHLORIDE
Recent Clinical Trials for ARGATROBAN IN SODIUM CHLORIDE

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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

See all ARGATROBAN IN SODIUM CHLORIDE clinical trials

Pharmacology for ARGATROBAN IN SODIUM CHLORIDE
Paragraph IV (Patent) Challenges for ARGATROBAN IN SODIUM CHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ARGATROBAN IN SODIUM CHLORIDE INJECTABLE;INTRAVENOUS argatroban 022434 2011-12-16

US Patents and Regulatory Information for ARGATROBAN IN SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eagle Pharms ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022434-001 Jun 29, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sandoz ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022485-001 May 9, 2011 AP RX Yes Yes   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
>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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Dow
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