dronabinol · Wellhouse Pharma · NDA 205525
Syndros
Earliest generic entry, as listed
6 Aug 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10265293, US 11253472, US 8222292, US 9345771.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10265293 | drug substance, drug product · sets the listed date | 6 Aug 2028 |
| US 11253472 | drug substance, drug product · sets the listed date | 6 Aug 2028 |
| US 8222292 | drug substance, drug product · sets the listed date | 6 Aug 2028 |
| US 9345771 | drug substance, drug product · sets the listed date | 6 Aug 2028 |
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 |
|---|---|---|---|
| 205525 · 001 · RLD · discontinued | solution, oral | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 6 Aug 2028 |