Orange Book product · Brand (NDA)
ADZENYS XR-ODT
AMPHETAMINE
At a glance
Jan 27, 2016
Approved
Brand (NDA)
Application
AB
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2016
10 yr 7 mo ago
Patent 8840924 expires
Listed drug product patent expiration.
Apr 09, 2026
2 mo ago
Today
Patent 8709491 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9017731 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9265737 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9839619 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Pharmaceutical detail
Active ingredient
AMPHETAMINE
Strength
EQ 3.1MG BASE
Dosage form
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 204326
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8840924 | Apr 09, 2026 | 2 mo ago | Product |
| 8709491 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9017731 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9265737 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9839619 | Jun 28, 2032 | in 6 yr 1 mo | Product |
