budesonide; formoterol fumarate · Astrazeneca · NDA 216579
Symbicort Aerosphere
Earliest generic entry, as listed · earliest of 2 marketed strengths
28 May 2030
Blocked by patent: US 10716753, US 9415009.
Listed patents · 2 unexpired
4 Orange Book listing rows for 2 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10716753 | drug product, use U-3203, U-4513 | 28 May 2030 |
| US 10716753 listing row | drug product, use U-3203 · sets the listed date | 28 May 2030 |
| US 10716753 listing row | drug product, use U-4513 · sets the listed date | 28 May 2030 |
| US 9415009 | use U-3203, U-4513 | 28 May 2030 |
| US 9415009 listing row | use U-3203 · sets the listed date | 28 May 2030 |
| US 9415009 listing row | use U-4513 · sets the listed date | 28 May 2030 |
Exclusivities · 2 unexpired
| I-988 | new indication (3 years) | 27 Apr 2029 |
| NS | new strength | 27 Apr 2029 |
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 |
|---|---|---|---|
| 216579 · 001 · RLD | aerosol, metered, inhalation | 0.16MG/INH;0.0048MG/INH | 28 May 2030 |
| 216579 · 002 · RLD | aerosol, metered, inhalation | 0.08MG/INH;0.0048MG/INH | 28 May 2030 |