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Last Updated: May 12, 2021

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ARIXTRA Drug Profile

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Which patents cover Arixtra, and what generic alternatives are available?

Arixtra is a drug marketed by Mylan Ireland Ltd and is included in one NDA.

The generic ingredient in ARIXTRA is fondaparinux sodium. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the fondaparinux sodium profile page.

Drug patent expirations by year for ARIXTRA
Drug Prices for ARIXTRA

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Recent Clinical Trials for ARIXTRA

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

SponsorPhase
Weill Medical College of Cornell UniversityPhase 4
Fondazione "Un Cuore per Milano" - a no profit foundationPhase 2
University of MilanPhase 2

See all ARIXTRA clinical trials

Pharmacology for ARIXTRA
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors

US Patents and Regulatory Information for ARIXTRA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-001 Dec 7, 2001 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-004 May 28, 2004 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-002 May 28, 2004 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-003 May 28, 2004 AP RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ARIXTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0084999 2002C/012 Belgium   Get Started for $10 PRODUCT NAME: FONDAPARINUX SODIQUE; REGISTRATION NO/DATE: EU/1/02/206/001 20020321
0084999 SPC/GB02/025 United Kingdom   Get Started for $10 SPC/GB02/025:, EXPIRES: 20080116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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