metaxalone · Primus Pharms · NDA 022503
Metaxalone
Earliest generic entry, as listed
14 May 2043
Blocked by patent: US 12485111.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12485111 | drug product, use U-4453 · sets the listed date | 14 May 2043 |
| US 11918559 | drug product | 29 Jul 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 |
|---|---|---|---|
| 022503 · 001 · RLD | tablet, oral | 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 14 May 2043 |