FDA Orange Book · active-ingredient family
Amphetamine
Amphetamine is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ADZENYS ER · NDA 204325
2
Brand (NDA)
1
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, extended release, tablet, orally disintegrating, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ADZENYS ERRLD | NEOS THERAPS INC | NDA 204325 | — | Sep 15, 2017 | |
| ADZENYS XR-ODTRLD×6 | NEOS THERAPS | NDA 204326 | AB | Jan 27, 2016 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMPHETAMINE×6 | ACTAVIS LABS FL INC | ANDA 209253 | AB | Jun 22, 2023 |
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 |
Amphetamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
