tizanidine hydrochloride · Fidelity Biopharma · NDA 216190
Ontralfy
Earliest generic entry, as listed
7 May 2042
Blocked by patent: US 12042484, US 12263158.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12042484 | drug product, use U-2779 · sets the listed date | 7 May 2042 |
| US 12263158 | drug product, use U-2779 · sets the listed date | 7 May 2042 |
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 |
|---|---|---|---|
| 216190 · 001 · RLD | solution, oral | EQ 2MG BASE/5ML | 7 May 2042 |