glycopyrrolate; indacaterol maleate · Novartis · NDA 207930
Utibron Neohaler
Earliest generic entry, as listed
20 Oct 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8182838.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8182838 | drug product · sets the listed date | 20 Oct 2028 |
| US 8479730 | drug product | 11 Oct 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207930 · 001 · RLD · discontinued | powder, inhalation | 15.6MCG/INH;27.5MCG/INH | 20 Oct 2028 |