cyclobenzaprine hydrochloride · Tonix · NDA 219428
Tonmya
Earliest generic entry, as listed
14 Mar 2034
Blocked by patent: US 10117936, US 10864175, US 9636408, US 9956188.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10117936 | drug product · sets the listed date | 14 Mar 2034 |
| US 10864175 | drug product · sets the listed date | 14 Mar 2034 |
| US 9636408 | drug product · sets the listed date | 14 Mar 2034 |
| US 9956188 | drug product · sets the listed date | 14 Mar 2034 |
Exclusivities · 1 unexpired
| NP | new product | 15 Aug 2028 |
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 |
|---|---|---|---|
| 219428 · 001 · RLD | tablet, sublingual | 2.8MG | 14 Mar 2034 |