Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 8, 2019

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Fondaparinux sodium - Generic Drug Details

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What are the generic sources for fondaparinux sodium and what is the scope of patent protection?

Fondaparinux sodium is the generic ingredient in two branded drugs marketed by Mylan Ireland Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Jiangsu Hengrui Med, and Scinopharm Taiwan, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for fondaparinux sodium. Seven suppliers are listed for this compound.

Recent Clinical Trials for fondaparinux sodium

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SponsorPhase
GlaxoSmithKlineN/A
Prairie Education and Research CooperativeN/A
American College of PhlebologyN/A

See all fondaparinux sodium clinical trials

Pharmacology for fondaparinux sodium
Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors

US Patents and Regulatory Information for fondaparinux sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206918-002 Dec 26, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-002 May 28, 2004 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Jiangsu Hengrui Med FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206812-003 May 15, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Ireland Ltd ARIXTRA fondaparinux sodium INJECTABLE;SUBCUTANEOUS 021345-003 May 28, 2004 AP RX Yes Yes   Start Trial   Start Trial   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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