sotalol hydrochloride · Azurity · NDA 205108
Sotylize
Earliest generic entry, as listed
31 Aug 2035
Blocked by patent: US 9724297.
Listed patents · 5 unexpired
8 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9724297 | drug product, use U-2096 · sets the listed date | 31 Aug 2035 |
| US 11850222 | use U-2096, U-2494 | 19 Nov 2034 |
| US 11850222 listing row | use U-2096 | 19 Nov 2034 |
| US 11850222 listing row | use U-2494 | 19 Nov 2034 |
| US 10206895 | drug product, use U-2096, U-2494 | 1 Apr 2034 |
| US 10206895 listing row | drug product, use U-2096 | 1 Apr 2034 |
| US 10206895 listing row | drug product, use U-2494 | 1 Apr 2034 |
| US 11013703 | drug product | 1 Apr 2034 |
| US 12290495 | use U-2096, U-2494 | 1 Apr 2034 |
| US 12290495 listing row | use U-2096 | 1 Apr 2034 |
| US 12290495 listing row | use U-2494 | 1 Apr 2034 |
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 |
|---|---|---|---|
| 205108 · 001 · RLD | solution, oral | 5MG/ML (5MG/ML) | 31 Aug 2035 |