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Last Updated: November 2, 2024

ARGATROBAN IN SODIUM CHLORIDE Drug Patent 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 Cipla, Gland Pharma Ltd, Sandoz, Accord Hlthcare, and Eugia Pharma Speclts. and is included in five NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

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. Eleven suppliers are listed for this compound. Additional details are available on the argatroban profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Argatroban In Sodium Chloride

A generic version of ARGATROBAN IN SODIUM CHLORIDE was approved as argatroban by HIKMA PHARM CO LTD on January 5th, 2012.

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

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

SponsorPhase
Veralox TherapeuticsPhase 2
Veralox TherapeuticsPhase 1
CelerionPhase 1

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 Strength NDA ANDAs Submitted Submissiondate
ARGATROBAN IN SODIUM CHLORIDE Injection argatroban 1 mg/mL, 50 mL vials 022434 1 2011-12-16

US Patents and Regulatory Information for ARGATROBAN IN SODIUM CHLORIDE

ARGATROBAN IN SODIUM CHLORIDE is protected by two US patents.

Patents protecting ARGATROBAN IN SODIUM CHLORIDE

Alcohol free formulation of argatroban
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING THROMBOSIS

Alcohol free formulation of argatroban
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022434-001 Jun 29, 2011 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sandoz ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 022485-001 May 9, 2011 AP RX Yes Yes ⤷  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
Gland Pharma Ltd ARGATROBAN IN SODIUM CHLORIDE argatroban INJECTABLE;INTRAVENOUS 205570-001 May 22, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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 IN SODIUM CHLORIDE

See the table below for patents covering ARGATROBAN IN SODIUM CHLORIDE around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2008039473 ⤷  Sign Up
Japan 2010504971 ⤷  Sign Up
Japan 5624766 ⤷  Sign Up
China 101516370 Alcohol free formulation of argatroban ⤷  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.