isavuconazonium sulfate · Astellas · NDA 207500, 207501
Cresemba
Earliest generic entry, as listed · earliest of 3 marketed strengths
8 Jun 2031
Blocked by exclusivity: PED.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10206879 | — | 14 Mar 2028 |
| US 10603280 | — | 14 Mar 2028 |
| US 10206879 | product | 14 Sep 2027 |
| US 10603280 | product | 14 Sep 2027 |
Exclusivities · 8 unexpired
| PED | pediatric (6 months added) | 8 Jun 2031 |
| ODE-454 | orphan drug (7 years) | 8 Dec 2030 |
| ODE-458 | orphan drug (7 years) | 8 Dec 2030 |
| ODE-453 | orphan drug (7 years) | 8 Dec 2030 |
| ODE-459 | orphan drug (7 years) | 8 Dec 2030 |
| GAIN | qualified infectious disease product | 6 Sep 2027 |
| PED | pediatric (6 months added) | 8 Jun 2027 |
| NPP | new patient population | 8 Dec 2026 |
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
- 24 Oct 2026Exclusivity expires within 90 days NPP · 207501-0018 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days NPP · 207500-0018 Dec 2026
- 24 Oct 2026Exclusivity expires within 90 days NPP · 207500-0028 Dec 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207500 · 001 · RLD | capsule, oral | 186MG | 8 Jun 2031 |
| 207500 · 002 · RLD | capsule, oral | 74.5MG | 8 Jun 2031 |
| 207501 · 001 · RLD | powder, intravenous | 372MG | 8 Jun 2031 |
Expired or delisted (6)
- US 6812238 · — · 30 Apr 2026
- US 6812238 · substance · 31 Oct 2025
- PED · 6 Sep 2022
- ODE* · 6 Mar 2022
- ODE-90 · 6 Mar 2022
- ODE-305 · 6 Mar 2022