rezafungin acetate · Mundipharma · NDA 217417
Rezzayo
Earliest generic entry, as listed
14 Jul 2038
Blocked by patent: US 11197909.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11197909 | drug substance, drug product, use U-3566 · sets the listed date | 14 Jul 2038 |
| US 11819533 | drug substance, drug product, use U-3566 | 11 Jul 2038 |
| US 11712459 | drug product, use U-3566 | 15 Mar 2037 |
| US 8722619 | drug substance, drug product, use U-3566 | 9 May 2036 |
| US 10702573 | drug substance, drug product, use U-3566 | 14 Mar 2033 |
| US 9526835 | drug substance, drug product, use U-3566 | 14 Mar 2033 |
| US 11654196 | drug substance, drug product, use U-3566 | 2 Mar 2032 |
Exclusivities · 3 unexpired
| GAIN | qualified infectious disease product | 22 Mar 2035 |
| GAIN | qualified infectious disease product | 22 Mar 2033 |
| ODE-426 | orphan drug (7 years) | 22 Mar 2030 |
| NCE | new chemical entity (5 years) | 22 Mar 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217417 · 001 · RLD | powder, intravenous | EQ 200MG BASE/VIAL | 14 Jul 2038 |