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Generated: December 11, 2017

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Which patents cover Argatroban, and when can generic versions of Argatroban launch?

Argatroban is a drug marketed by Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis Pharms Corp, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd. and is included in eleven 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. Ten suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the argatroban profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi UsaARGATROBANargatrobanINJECTABLE;INJECTION201811-001Mar 23, 2015APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Par Sterile ProductsARGATROBANargatrobanINJECTABLE;INJECTION091665-001Jun 30, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hospira IncARGATROBANargatrobanINJECTABLE;INJECTION204120-001Sep 21, 2016APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Gland Pharma LtdARGATROBAN IN SODIUM CHLORIDEargatrobanINJECTABLE;IV (INFUSION)205570-001May 22, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaARGATROBAN IN 0.9% SODIUM CHLORIDEargatrobanINJECTABLE;IV (INFUSION)206769-001Dec 15, 2014RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Hikma Pharm Co LtdARGATROBANargatrobanINJECTABLE;INJECTION203049-002Sep 30, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Hikma Pharm Co LtdARGATROBANargatrobanINJECTABLE;INJECTION203049-001Jan 5, 2012APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Novartis Pharms CorpARGATROBANargatrobanINJECTABLE;INJECTION020883-001Jun 30, 2000APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Mylan InstitutionalARGATROBANargatrobanINJECTABLE;INJECTION202626-001Jun 30, 2014APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Eagle PharmsARGATROBAN IN SODIUM CHLORIDEargatrobanINJECTABLE;IV (INFUSION)022434-001Jun 29, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for ARGATROBAN

Drugname Dosage Strength RLD Submissiondate
argatroban in sodium chlorideInjection1 mg/mL, 50 mL vialsArgatroban12/16/2011
argatrobanInjection100 mg/mL, 2.5 mL vialsArgatroban9/24/2007

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US Army
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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 verifification 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.

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