FDA Orange Book
Generic for Arixtra
Arixtra contains fondaparinux. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Arixtra is fondaparinux. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Arixtra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 10MG/0.8ML (10MG/0.8ML) | Marketed (Rx) | AP | 3 | AP |
| solution, subcutaneous | 2.5MG/0.5ML (2.5MG/0.5ML) | Marketed (Rx) | AP | 3 | AP |
| solution, subcutaneous | 5MG/0.4ML (5MG/0.4ML) | Marketed (Rx) | AP | 3 | AP |
| solution, subcutaneous | 7.5MG/0.6ML (7.5MG/0.6ML) | Marketed (Rx) | AP | 3 | AP |
NDA 021345, held by MYLAN IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fondaparinux
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 091316 | AP (A-rated, therapeutically equivalent) | July 11, 2011 | 10MG/0.8ML (10MG/0.8ML), 2.5MG/0.5ML (2.5MG/0.5ML), 5MG/0.4ML (5MG/0.4ML), 7.5MG/0.6ML (7.5MG/0.6ML) |
| EUGIA PHARMA SPECIALITIES LTD | 206918 | AP (A-rated, therapeutically equivalent) | December 26, 2017 | 10MG/0.8ML (10MG/0.8ML), 2.5MG/0.5ML (2.5MG/0.5ML), 5MG/0.4ML (5MG/0.4ML), 7.5MG/0.6ML (7.5MG/0.6ML) |
| SCINOPHARM TAIWAN LTD | 208615 | AP (A-rated, therapeutically equivalent) | November 14, 2018 | 10MG/0.8ML (10MG/0.8ML), 2.5MG/0.5ML (2.5MG/0.5ML), 5MG/0.4ML (5MG/0.4ML), 7.5MG/0.6ML (7.5MG/0.6ML) |
Arixtra NDC codes
Questions
Is there a generic for Arixtra?
Yes. The generic name for Arixtra is fondaparinux. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Arixtra?
The active ingredient in Arixtra is fondaparinux, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.