formoterol fumarate; glycopyrrolate · Astrazeneca · NDA 208294
Bevespi Aerosphere
Earliest generic entry, as listed
17 Mar 2031
Blocked by patent: US 8815258. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8815258 | use U-2889 · sets the listed date | 17 Mar 2031 |
| US 10716753 | drug product, use U-2889 | 28 May 2030 |
| US 8324266 | use U-2889 | 28 May 2030 |
| US 8703806 | use U-2889 | 28 May 2030 |
| US 8808713 | drug product, use U-2889 | 28 May 2030 |
| US 9415009 | use U-2889 | 28 May 2030 |
| US 9463161 | drug product, use U-2889 | 28 May 2030 |
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 |
|---|---|---|---|
| 208294 · 001 · RLD | aerosol, metered, inhalation | 0.0048MG/INH;0.0090MG/INH | 17 Mar 2031 |