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Fondaparinux sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fondaparinux sodium?

Fondaparinux sodium is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd and Mylan Ireland Ltd, and is included in two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: fondaparinux sodium

Tradenames:2
Patents:1
Applicants:2
NDAs:2
Drug Master File Entries: see list14
Suppliers / Packagers: see list4
Bulk Api Vendors: see list11
Clinical Trials: see list941
Patent Applications: see list1,536
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fondaparinux sodium at DailyMed

Pharmacology for Ingredient: fondaparinux sodium

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
FONDAPARINUX SODIUM
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS091316-002Jul 11, 2011RXNoNo► Subscribe► Subscribe
Mylan Ireland Ltd
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-001Dec 7, 2001RXYesYes► Subscribe► Subscribe
Mylan Ireland Ltd
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-003May 28, 2004RXYesYes► Subscribe► Subscribe
Dr Reddys Labs Ltd
FONDAPARINUX SODIUM
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS091316-001Jul 11, 2011RXNoNo► Subscribe► Subscribe
Mylan Ireland Ltd
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-004May 28, 2004RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fondaparinux sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Ireland Ltd
ARIXTRA
fondaparinux sodium
INJECTABLE;SUBCUTANEOUS021345-001Dec 7, 20014,818,816► Subscribe
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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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