ensifentrine · Msd · NDA 217389
Ohtuvayre
Earliest generic entry, as listed
25 Jun 2044
Blocked by patent: US 12251384.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12251384 | drug product · sets the listed date | 25 Jun 2044 |
| US 12409180 | drug product | 20 Feb 2043 |
| US 10945950 | drug product | 15 Sep 2035 |
| US 9956171 | drug product, use U-3962 | 15 Sep 2035 |
| US 9062047 | drug substance, use U-3962 | 21 Aug 2031 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 26 Jun 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217389 · 001 · RLD | suspension, inhalation | 3MG/2.5ML | 25 Jun 2044 |