amphetamine · Neos Theraps · NDA 204326
Adzenys Xr-Odt
Earliest generic entry, as listed · earliest of 6 marketed strengths
28 Jun 2032
Blocked by patent: US 8709491, US 9017731, US 9265737, US 9839619.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8709491 | product | 28 Jun 2032 |
| US 9017731 | product | 28 Jun 2032 |
| US 9265737 | product | 28 Jun 2032 |
| US 9839619 | product | 28 Jun 2032 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204326 · 001 · RLD | tablet, orally disintegrating, extended release, oral | EQ 3.1MG BASE | 28 Jun 2032 |
| 204326 · 002 · RLD | tablet, orally disintegrating, extended release, oral | EQ 6.3MG BASE | 28 Jun 2032 |
| 204326 · 003 · RLD | tablet, orally disintegrating, extended release, oral | EQ 9.4MG BASE | 28 Jun 2032 |
| 204326 · 004 · RLD | tablet, orally disintegrating, extended release, oral | EQ 12.5MG BASE | 28 Jun 2032 |
| 204326 · 005 · RLD | tablet, orally disintegrating, extended release, oral | EQ 15.7MG BASE | 28 Jun 2032 |
| 204326 · 006 · RLD | tablet, orally disintegrating, extended release, oral | EQ 18.8MG BASE | 28 Jun 2032 |
Expired or delisted (1)
- US 8840924 · product · 9 Apr 2026