FDA Orange Book · active-ingredient family
Fondaparinux sodium
Fondaparinux sodium is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ARIXTRA · NDA 021345
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ARIXTRARLD×4 | MYLAN IRELAND LTD | NDA 021345 | AP | Dec 07, 2001 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FONDAPARINUX SODIUM | BRIGHTGENE | ANDA 218312 | — | Dec 18, 2024 | |
| FONDAPARINUX SODIUM×4 | HANGZHOU ZHONGMEI | ANDA 216493 | — | Aug 19, 2024 | |
| FONDAPARINUX SODIUM×4 | SCINOPHARM TAIWAN | ANDA 208615 | AP | Nov 14, 2018 | |
| FONDAPARINUX SODIUM×4 | HENGRUI PHARMA | ANDA 206812 | AP | May 15, 2018 | |
| FONDAPARINUX SODIUM×4 | EUGIA PHARMA | ANDA 206918 | AP | Dec 26, 2017 | |
| FONDAPARINUX SODIUM×4 | DR REDDYS LABS LTD | ANDA 091316 | AP | Jul 11, 2011 |
Listed patents
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.
Fondaparinux sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
