mycophenolate mofetil · Azurity · NDA 216482
Myhibbin
Earliest generic entry, as listed
16 Aug 2039
Blocked by patent: US 11931455, US 12097284, US 12097285, US 12194143, US 12226526.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11931455 | product, use U-1752 | 16 Aug 2039 |
| US 12097284 | product | 16 Aug 2039 |
| US 12097285 | product, use U-1752 | 16 Aug 2039 |
| US 12194143 | product, use U-1752 | 16 Aug 2039 |
| US 12226526 | product, use U-1752 | 16 Aug 2039 |
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 |
|---|---|---|---|
| 216482 · 001 · RLD | suspension, oral | 200MG/ML | 16 Aug 2039 |