fondaparinux sodium · Mylan Ireland Ltd · NDA 021345
Arixtra
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021345 · 001 · RLD | solution, subcutaneous | 2.5MG/0.5ML (2.5MG/0.5ML) | open |
| 021345 · 002 · RLD | solution, subcutaneous | 5MG/0.4ML (5MG/0.4ML) | open |
| 021345 · 003 · RLD | solution, subcutaneous | 7.5MG/0.6ML (7.5MG/0.6ML) | open |
| 021345 · 004 · RLD | solution, subcutaneous | 10MG/0.8ML (10MG/0.8ML) | open |