budesonide; formoterol fumarate; glycopyrrolate · Astrazeneca Ab · NDA 212122
Breztri Aerosphere
Earliest generic entry, as listed · earliest of 2 marketed strengths
5 Oct 2038
Blocked by patent: US 11331442, US 11833292.
Listed patents · 9 unexpired
16 Orange Book listing rows for 9 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11331442 | drug product · sets the listed date | 5 Oct 2038 |
| US 11833292 | drug product · sets the listed date | 5 Oct 2038 |
| US 8815258 | use U-2889, U-4503 | 17 Mar 2031 |
| US 8815258 listing row | use U-2889 | 17 Mar 2031 |
| US 8815258 listing row | use U-4503 | 17 Mar 2031 |
| US 10716753 | drug product, use U-2889, U-4503 | 28 May 2030 |
| US 10716753 listing row | drug product, use U-2889 | 28 May 2030 |
| US 10716753 listing row | drug product, use U-4503 | 28 May 2030 |
| US 8324266 | use U-2889, U-4503 | 28 May 2030 |
| US 8324266 listing row | use U-2889 | 28 May 2030 |
| US 8324266 listing row | use U-4503 | 28 May 2030 |
| US 8703806 | use U-2889, U-4503 | 28 May 2030 |
| US 8703806 listing row | use U-2889 | 28 May 2030 |
| US 8703806 listing row | use U-4503 | 28 May 2030 |
| US 8808713 | drug product, use U-2889, U-4503 | 28 May 2030 |
| US 8808713 listing row | drug product, use U-2889 | 28 May 2030 |
| US 8808713 listing row | drug product, use U-4503 | 28 May 2030 |
| US 9415009 | use U-2889, U-4503 | 28 May 2030 |
| US 9415009 listing row | use U-2889 | 28 May 2030 |
| US 9415009 listing row | use U-4503 | 28 May 2030 |
| US 9463161 | drug product, use U-2889, U-4503 | 28 May 2030 |
| US 9463161 listing row | drug product, use U-2889 | 28 May 2030 |
| US 9463161 listing row | drug product, use U-4503 | 28 May 2030 |
Exclusivities · 1 unexpired
| 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 |
|---|---|---|---|
| 212122 · 001 · RLD | aerosol, metered, inhalation | 0.16MG/INH;0.0048MG/INH;0.009MG/INH | 5 Oct 2038 |
| 212122 · 002 · RLD | aerosol, metered, inhalation | 0.16MG/INH;0.0048MG/INH;0.018MG/INH | 5 Oct 2038 |