dronedarone hydrochloride · Sanofi Aventis Us · NDA 022425
Multaq
Earliest generic entry, as listed
30 Jun 2031
Blocked by patent: US 8602215. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8602215 | use U-1473 · sets the listed date | 30 Jun 2031 |
| US 8410167 | use U-1387, U-1388 | 16 Apr 2029 |
| US 8410167 listing row | use U-1387 | 16 Apr 2029 |
| US 8410167 listing row | use U-1388 | 16 Apr 2029 |
| US 9107900 | use U-1726, U-1728 | 16 Apr 2029 |
| US 9107900 listing row | use U-1726 | 16 Apr 2029 |
| US 9107900 listing row | use U-1728 | 16 Apr 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 022425 · 001 · RLD | tablet, oral | EQ 400MG BASE | 30 Jun 2031 |