trazodone hydrochloride · Pragma · NDA 018207
Desyrel
Earliest generic entry, as listed · earliest of 4 marketed strengths
13 Mar 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8133893.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8133893 | drug substance, drug product · sets the listed date | 13 Mar 2029 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 018207 · 001 · RLD · discontinued | tablet, oral | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 13 Mar 2029 |
| 018207 · 002 · RLD · discontinued | tablet, oral | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 13 Mar 2029 |
| 018207 · 003 · RLD · discontinued | tablet, oral | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 13 Mar 2029 |
| 018207 · 004 · RLD · discontinued | tablet, oral | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 13 Mar 2029 |