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Last Updated: May 12, 2021

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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.

Summary for fondaparinux sodium
Recent Clinical Trials for fondaparinux sodium

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

SponsorPhase
GlaxoSmithKlineN/A
American College of PhlebologyN/A
Prairie Education and Research CooperativeN/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
Dr Reddys Labs Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 091316-001 Jul 11, 2011 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Aurobindo Pharma Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206918-001 Dec 26, 2017 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Dr Reddys Labs Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 091316-003 Jul 11, 2011 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Jiangsu Hengrui Med FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206812-003 May 15, 2018 AP RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Aurobindo Pharma Ltd FONDAPARINUX SODIUM fondaparinux sodium INJECTABLE;SUBCUTANEOUS 206918-004 Dec 26, 2017 AP RX No No   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

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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Boehringer Ingelheim
Express Scripts
AstraZeneca
Merck

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