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
- MYLAN IRELAND LTDNDA 02134520014 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx AP 5MG/0.4ML (5MG/0.4ML) SOLUTION SUBCUTANEOUS Rx AP 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION SUBCUTANEOUS Rx AP 10MG/0.8ML (10MG/0.8ML) SOLUTION SUBCUTANEOUS Rx AP
Generic (ANDA) products (6)
Abbreviated applications
- FONDAPARINUX SODIUMBRIGHTGENEANDA 2183122024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Discontinued — - FONDAPARINUX SODIUMHANGZHOU ZHONGMEIANDA 21649320244 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Discontinued — 5MG/0.4ML (5MG/0.4ML) SOLUTION SUBCUTANEOUS Discontinued — 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION SUBCUTANEOUS Discontinued — 10MG/0.8ML (10MG/0.8ML) SOLUTION SUBCUTANEOUS Discontinued — - FONDAPARINUX SODIUMSCINOPHARM TAIWANANDA 20861520184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx AP 5MG/0.4ML (5MG/0.4ML) SOLUTION SUBCUTANEOUS Rx AP 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION SUBCUTANEOUS Rx AP 10MG/0.8ML (10MG/0.8ML) SOLUTION SUBCUTANEOUS Rx AP - FONDAPARINUX SODIUMHENGRUI PHARMAANDA 20681220184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Discontinued — 5MG/0.4ML (5MG/0.4ML) SOLUTION SUBCUTANEOUS Discontinued — 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION SUBCUTANEOUS Discontinued — 10MG/0.8ML (10MG/0.8ML) SOLUTION SUBCUTANEOUS Discontinued — - FONDAPARINUX SODIUMEUGIA PHARMAANDA 20691820174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx AP 5MG/0.4ML (5MG/0.4ML) SOLUTION SUBCUTANEOUS Rx AP 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION SUBCUTANEOUS Rx AP 10MG/0.8ML (10MG/0.8ML) SOLUTION SUBCUTANEOUS Rx AP - FONDAPARINUX SODIUMDR REDDYS LABS LTDANDA 09131620114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION SUBCUTANEOUS Rx AP 5MG/0.4ML (5MG/0.4ML) SOLUTION SUBCUTANEOUS Rx AP 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION SUBCUTANEOUS Rx AP 10MG/0.8ML (10MG/0.8ML) SOLUTION SUBCUTANEOUS Rx AP
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
First approval
25 yr 2 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
