irinotecan hydrochloride · Ipsen · NDA 207793
Onivyde
Earliest generic entry, as listed
15 Oct 2036
Blocked by patent: US 10456360, US 10993914, US 12059497.
Listed patents · 17 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10456360 | product | 15 Oct 2036 |
| US 10993914 | product | 15 Oct 2036 |
| US 12059497 | product | 15 Oct 2036 |
| US 11344552 | use U-3824 | 19 Aug 2036 |
| US 10980795 | use U-1848 | 12 Jun 2033 |
| US 11369597 | use U-1848 | 12 Jun 2033 |
| US 12364691 | use U-1848 | 12 Jun 2033 |
| US 9339497 | use U-1848 | 12 Jun 2033 |
| US 9364473 | use U-1856 | 12 Jun 2033 |
| US 9452162 | use U-1899 | 12 Jun 2033 |
| US 9492442 | use U-1848 | 12 Jun 2033 |
| US 9492442 | use U-1917 | 12 Jun 2033 |
| US 9492442 | use U-1899 | 12 Jun 2033 |
| US 9717724 | use U-2091 | 12 Jun 2033 |
| US 9717724 | use U-1848 | 12 Jun 2033 |
| US 8147867 | substance, product | 29 Aug 2028 |
| US 8329213 | substance, product | 6 Jan 2027 |
Exclusivities · 2 unexpired
| ODE-463 | orphan drug (7 years) | 13 Feb 2031 |
| I-932 | new indication (3 years) | 13 Feb 2027 |
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 |
|---|---|---|---|
| 207793 · 001 · RLD | injectable, liposomal, intravenous | EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) | 15 Oct 2036 |