amphetamine sulfate · Azurity · NDA 209905
Evekeo Odt
Earliest generic entry, as listed · earliest of 5 marketed strengths
10 Mar 2037
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10441554, US 11160772, US 11896562.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10441554 | drug product · sets the listed date | 10 Mar 2037 |
| US 11160772 | drug product · sets the listed date | 10 Mar 2037 |
| US 11896562 | use U-3299 · sets the listed date | 10 Mar 2037 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209905 · 001 · RLD · discontinued | tablet, orally disintegrating, oral | 5MG | 10 Mar 2037 |
| 209905 · 002 · RLD · discontinued | tablet, orally disintegrating, oral | 10MG | 10 Mar 2037 |
| 209905 · 003 · RLD · discontinued | tablet, orally disintegrating, oral | 15MG | 10 Mar 2037 |
| 209905 · 004 · RLD · discontinued | tablet, orally disintegrating, oral | 20MG | 10 Mar 2037 |
| 209905 · 005 · RLD · discontinued | tablet, orally disintegrating, oral | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 10 Mar 2037 |