quizartinib dihydrochloride · Daiichi Sankyo Inc · NDA 216993
Vanflyta
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Sep 2033
Blocked by patent: US 9675549.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9675549 | product | 30 Sep 2033 |
| US 8357690 | use U-3661 | 26 Feb 2031 |
| US 9555040 | use U-3661 | 14 May 2030 |
| US 8836218 | use U-3661 | 23 Mar 2030 |
| US 7968543 | product, use U-3661 | 15 Aug 2029 |
| US 8865710 | product | 15 Aug 2029 |
| US 7820657 | substance | 26 Sep 2028 |
| US 8129374 | use U-3661 | 16 Mar 2027 |
| US 8557810 | product | 16 Mar 2027 |
| US 8883783 | substance | 16 Mar 2027 |
| US 9585892 | use U-3661 | 16 Mar 2027 |
Exclusivities · 2 unexpired
| ODE-437 | orphan drug (7 years) | 20 Jul 2030 |
| NCE | new chemical entity (5 years) | 20 Jul 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216993 · 001 · RLD | tablet, oral | EQ 17.7MG BASE | 30 Sep 2033 |
| 216993 · 002 · RLD | tablet, oral | EQ 26.5MG BASE | 30 Sep 2033 |