cytarabine; daunorubicin · Jazz Pharms Therap · NDA 209401
Vyxeos
Earliest generic entry, as listed
15 Apr 2033
Blocked by patent: US 10028912 (pediatric extension), US 10166184 (pediatric extension), US 10835492 (pediatric extension).
Listed patents · 7 unexpired
15 Orange Book listing rows for 7 patents, including 7 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10028912 | drug product, use U-3149, U-3150 | 15 Apr 2033 |
| US 10028912 listing row | drug product, use U-3149 | 15 Oct 2032 |
| US 10028912 listing row | drug product, use U-3150 | 15 Oct 2032 |
| US 10028912 listing row | pediatric extension · sets the listed date | 15 Apr 2033 |
| US 10166184 | drug product, use U-3149 | 15 Apr 2033 |
| US 10166184 listing row | drug product, use U-3149 | 15 Oct 2032 |
| US 10166184 listing row | pediatric extension · sets the listed date | 15 Apr 2033 |
| US 10835492 | use U-3150 | 15 Apr 2033 |
| US 10835492 listing row | use U-3150 | 15 Oct 2032 |
| US 10835492 listing row | pediatric extension · sets the listed date | 15 Apr 2033 |
| US 8092828 | use U-3147 | 1 Oct 2029 |
| US 8092828 listing row | use U-3147 | 1 Apr 2029 |
| US 8092828 listing row | pediatric extension | 1 Oct 2029 |
| US 8022279 | drug product, use U-3147 | 14 Mar 2028 |
| US 8022279 listing row | drug product, use U-3147 | 14 Sep 2027 |
| US 8022279 listing row | pediatric extension | 14 Mar 2028 |
| US 7850990 | drug product, use U-3147 | 23 Jul 2027 |
| US 7850990 listing row | drug product, use U-3147 | 23 Jan 2027 |
| US 7850990 listing row | pediatric extension | 23 Jul 2027 |
| US 9271931 | drug product | 23 Jul 2027 |
| US 9271931 listing row | drug product | 23 Jan 2027 |
| US 9271931 listing row | pediatric extension | 23 Jul 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 30 Sep 2028 |
| ODE-350 | orphan drug (7 years) | 30 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 |
|---|---|---|---|
| 209401 · 001 · RLD | powder, intravenous | 100MG;44MG | 15 Apr 2033 |
Expired or delisted (1)
- US 8518437 · product · 7 Jun 2026