You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Argatroban - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug 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

See drug prices for argatroban

Recent Clinical Trials for argatroban

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

SponsorPhase
Veralox TherapeuticsPhase 2
Veralox TherapeuticsPhase 1
CelerionPhase 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
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
Fresenius Kabi Usa ARGATROBAN argatroban INJECTABLE;INJECTION 201811-001 Mar 23, 2015 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Caplin ARGATROBAN argatroban INJECTABLE;INJECTION 214235-001 Jan 21, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Pharm Co Ltd ARGATROBAN argatroban INJECTABLE;INJECTION 203049-002 Sep 30, 2016 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

Make Better Decisions: Try a trial or see plans & pricing

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.