dihydroergotamine mesylate · Impel Pharms · NDA 213436
Trudhesa
Earliest generic entry, as listed
4 Jan 2039
Blocked by patent: US 11185497. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11185497 | use U-3218 · sets the listed date | 4 Jan 2039 |
| US 11266799 | drug product | 5 Nov 2036 |
| US 9919117 | drug product, use U-3218 | 17 Mar 2033 |
| US 10940278 | drug product | 23 Jan 2033 |
| US 10507295 | drug product | 25 Dec 2032 |
| US 9550036 | drug product | 5 Sep 2032 |
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 |
|---|---|---|---|
| 213436 · 001 · RLD | spray, metered, nasal | 0.725MG/SPRAY | 4 Jan 2039 |