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FDA Orange Book · active-ingredient family

Fondaparinux sodium

Fondaparinux sodium: 1 brand, 6 generics; first approved Dec 07, 2001; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available: 6 ANDA applications approved.

Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
25

Brand (NDA) products

Originator applications
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  • ARIXTRARLDRS
    NDA 02134520014 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRxAP
    5MG/0.4ML (5MG/0.4ML)SOLUTIONSUBCUTANEOUSRxAP
    7.5MG/0.6ML (7.5MG/0.6ML)SOLUTIONSUBCUTANEOUSRxAP
    10MG/0.8ML (10MG/0.8ML)SOLUTIONSUBCUTANEOUSRxAP

Generic (ANDA) products (6)

Abbreviated applications
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  • FONDAPARINUX SODIUM
    ANDA 2183122024
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSDiscontinued-
  • FONDAPARINUX SODIUM
    ANDA 21649320244 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    5MG/0.4ML (5MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    7.5MG/0.6ML (7.5MG/0.6ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    10MG/0.8ML (10MG/0.8ML)SOLUTIONSUBCUTANEOUSDiscontinued-
  • FONDAPARINUX SODIUM
    ANDA 20861520184 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRxAP
    5MG/0.4ML (5MG/0.4ML)SOLUTIONSUBCUTANEOUSRxAP
    7.5MG/0.6ML (7.5MG/0.6ML)SOLUTIONSUBCUTANEOUSRxAP
    10MG/0.8ML (10MG/0.8ML)SOLUTIONSUBCUTANEOUSRxAP
  • FONDAPARINUX SODIUM
    ANDA 20681220184 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    5MG/0.4ML (5MG/0.4ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    7.5MG/0.6ML (7.5MG/0.6ML)SOLUTIONSUBCUTANEOUSDiscontinued-
    10MG/0.8ML (10MG/0.8ML)SOLUTIONSUBCUTANEOUSDiscontinued-
  • FONDAPARINUX SODIUM
    ANDA 20691820174 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRxAP
    5MG/0.4ML (5MG/0.4ML)SOLUTIONSUBCUTANEOUSRxAP
    7.5MG/0.6ML (7.5MG/0.6ML)SOLUTIONSUBCUTANEOUSRxAP
    10MG/0.8ML (10MG/0.8ML)SOLUTIONSUBCUTANEOUSRxAP
  • FONDAPARINUX SODIUM
    ANDA 09131620114 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    2.5MG/0.5ML (2.5MG/0.5ML)SOLUTIONSUBCUTANEOUSRxAP
    5MG/0.4ML (5MG/0.4ML)SOLUTIONSUBCUTANEOUSRxAP
    7.5MG/0.6ML (7.5MG/0.6ML)SOLUTIONSUBCUTANEOUSRxAP
    10MG/0.8ML (10MG/0.8ML)SOLUTIONSUBCUTANEOUSRxAP

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Approval history

FDA approval span
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First approval
25 yr 3 mo ago
Most recent approval
1 yr 10 mo ago

Approvals span 2001–2024 across 7 FDA applications.

Brand (NDA) 114%
Generic (ANDA) 686%

Fondaparinux sodium: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

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