itraconazole · Mayne Pharma · NDA 208901
Tolsura
Earliest generic entry, as listed
21 Jun 2033
Blocked by patent: US 10463740, US 10806792, US 8921374, US 9272046, US 9713642.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10463740 | drug product, use U-2453 · sets the listed date | 21 Jun 2033 |
| US 10806792 | drug product · sets the listed date | 21 Jun 2033 |
| US 8921374 | drug product · sets the listed date | 21 Jun 2033 |
| US 9272046 | drug product · sets the listed date | 21 Jun 2033 |
| US 9713642 | use U-2453 · sets the listed date | 21 Jun 2033 |
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 |
|---|---|---|---|
| 208901 · 001 · RLD | capsule, oral | 65MG | 21 Jun 2033 |