beclomethasone dipropionate; formoterol fumarate; glycopyrrolate · Chiesi · NDA 219622
Trimbow
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Dec 2034
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10617638.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10617638 | drug product, use U-4538 · sets the listed date | 23 Dec 2034 |
| US 10159645 | drug product, use U-4538 | 23 Dec 2030 |
| US 10806701 | drug product | 23 Dec 2030 |
| US 11389401 | drug product | 23 Dec 2030 |
| US 11590074 | use U-4538 | 23 Dec 2030 |
| US 12357568 | drug product, use U-4538 | 23 Dec 2030 |
Exclusivities · 1 unexpired
| NP | new product | 14 May 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 |
|---|---|---|---|
| 219622 · 001 · RLD · discontinued | aerosol, metered, inhalation | 0.086MG/INH;0.0049MG/INH;0.0106MG/INH | 23 Dec 2034 |
| 219622 · 002 · RLD · discontinued | aerosol, metered, inhalation | 0.172MG/INH;0.0049MG/INH;0.0106MG/INH | 23 Dec 2034 |