deferiprone · Chiesi · NDA 021825, 208030, 212269
Ferriprox
Earliest generic entry, as listed · earliest of 3 marketed strengths
30 Apr 2028
Other strengths are listed to 25 Oct 2038.
Blocked by exclusivity: ODE-417, ODE-420, ODE-421, ODE-418, ODE-419.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10780055 | product, use U-3083 | 25 Oct 2038 |
| US 10940115 | product, use U-3083 | 25 Oct 2038 |
| US 10940116 | product | 25 Oct 2038 |
| US 11357731 | use U-3083 | 25 Oct 2038 |
| US 11458103 | product | 25 Oct 2038 |
| US 11723874 | use U-3083 | 25 Oct 2038 |
| US 8703156 | product, use U-3083 | 26 Oct 2029 |
Exclusivities · 5 unexpired
| ODE-417 | orphan drug (7 years) | 30 Apr 2028 |
| ODE-420 | orphan drug (7 years) | 30 Apr 2028 |
| ODE-421 | orphan drug (7 years) | 30 Apr 2028 |
| ODE-418 | orphan drug (7 years) | 30 Apr 2028 |
| ODE-419 | orphan drug (7 years) | 30 Apr 2028 |
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
- 25 Oct 2026Generic approved · 021825-00111 Dec 2025
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021825 · 001 · RLD · discontinued | tablet, oral | 500MG | 30 Apr 2028 |
| 021825 · 002 · RLD | tablet, oral | 1GM | 30 Apr 2028 |
| 208030 · 001 · RLD | solution, oral | 100MG/ML | 26 Oct 2029 |
| 208030 · 002 · RLD · discontinued | solution, oral | 80MG/ML | 26 Oct 2029 |
| 212269 · 001 · RLD | tablet, oral | 1GM | 25 Oct 2038 |