vamorolone · Catalyst Pharms · NDA 215239
Agamree
Earliest generic entry, as listed
16 Jul 2040
Blocked by patent: US 11382922.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11382922 | substance, product | 16 Jul 2040 |
| US 11471471 | use U-3747 | 17 Mar 2040 |
| US 12201639 | substance, product, use U-3747 | 17 Mar 2040 |
| US 8334279 | use U-3747 | 23 Apr 2034 |
| US 11690853 | use U-3747 | 7 Mar 2033 |
| US 10857161 | product, use U-3747 | 28 May 2029 |
| US 11833159 | product | 28 May 2029 |
Exclusivities · 2 unexpired
| ODE-450 | orphan drug (7 years) | 26 Oct 2030 |
| NCE | new chemical entity (5 years) | 26 Oct 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 |
|---|---|---|---|
| 215239 · 001 · RLD | suspension, oral | 40MG/ML | 16 Jul 2040 |