ciclesonide · Azurity · NDA 021658
Alvesco
Earliest generic entry, as listed · earliest of 2 marketed strengths
1 Feb 2028
Blocked by patent: US 8371292. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8371292 | use U-1355 | 1 Feb 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021658 · 002 · RLD | aerosol, metered, inhalation | 0.08MG/INH | 1 Feb 2028 |
| 021658 · 003 · RLD | aerosol, metered, inhalation | 0.16MG/INH | 1 Feb 2028 |