etripamil · Milestone Pharms Usa · NDA 218571
Cardamyst
Earliest generic entry, as listed
15 Jul 2042
Blocked by patent: US 12257224. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12257224 | use U-4370 · sets the listed date | 15 Jul 2042 |
| US 10117848 | drug product, use U-4370 | 13 Apr 2036 |
| US 10010522 | use U-38 | 19 Jun 2028 |
| US 10010523 | drug substance | 19 Jun 2028 |
| US 9227918 | drug product | 19 Jun 2028 |
| US 9463179 | use U-4370 | 19 Jun 2028 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 12 Dec 2030 |
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 |
|---|---|---|---|
| 218571 · 001 · RLD | spray, nasal | 70MG | 15 Jul 2042 |