sotalol hydrochloride · Altathera Pharms Llc · NDA 022306
Sotalol Hydrochloride
Earliest generic entry, as listed
21 Aug 2039
Blocked by patent: US 11583216. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11583216 | use U-3549 | 21 Aug 2039 |
| US 10799138 | use U-3549 | 5 Apr 2039 |
| US 10799138 | use U-3125 | 5 Apr 2039 |
| US 12569183 | use U-4456 | 5 Apr 2039 |
| US 10512620 | use U-2769 | 14 Aug 2038 |
| US 10512620 | use U-3547 | 14 Aug 2038 |
| US 11696902 | use U-2769 | 14 Aug 2038 |
| US 12390431 | use U-2769 | 14 Aug 2038 |
| US 12740947 | use U-2769 | 14 Aug 2038 |
| US 12403109 | use U-2769 | 14 Aug 2028 |
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 |
|---|---|---|---|
| 022306 · 001 · RLD | solution, intravenous | 150MG/10ML (15MG/ML) | 21 Aug 2039 |