ganaxolone · Immedica Pharma · NDA 215904
Ztalmy
Earliest generic entry, as listed
30 Sep 2042
Blocked by patent: US 12115169, US 12268696. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 11 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12115169 | use U-3374 · sets the listed date | 30 Sep 2042 |
| US 12268696 | use U-3374 · sets the listed date | 30 Sep 2042 |
| US 10603308 | use U-3374 | 10 Aug 2037 |
| US 12144801 | use U-4034 | 10 Aug 2037 |
| US 8318714 | drug product | 28 Nov 2031 |
| US 7858609 | drug product | 28 Nov 2026 |
| US 8022054 | drug product | 28 Nov 2026 |
| US 8367651 | drug product | 28 Nov 2026 |
| US 8618087 | use U-3374 | 28 Nov 2026 |
| US 9029355 | drug product | 28 Nov 2026 |
| US 9056116 | use U-3374 | 28 Nov 2026 |
Exclusivities · 3 unexpired
| ODE-395 | orphan drug (7 years) | 1 Jun 2029 |
| D-197 | new dosing schedule | 16 Oct 2028 |
| NCE | new chemical entity (5 years) | 1 Jun 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 |
|---|---|---|---|
| 215904 · 001 · RLD | suspension, oral | 50MG/ML | 30 Sep 2042 |