FDA Orange Book · active-ingredient family
Amphetamine; amphetamine aspartate/dextroamphetamine sulfate
Amphetamine; amphetamine aspartate/dextroamphetamine sulfate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DYANAVEL XR 10 · NDA 210526
2
Brand (NDA)
0
Generics (ANDA)
11
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, extended release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DYANAVEL XR 10RLD×4 | TRIS PHARMA INC | NDA 210526 | — | Nov 04, 2021 | |
| DYANAVEL XRRLD | TRIS PHARMA INC | NDA 208147 | — | Oct 19, 2015 |
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8597684 | Mar 15, 2027 | in 9 mo | Product |
| 10086087 | Mar 15, 2027 | in 9 mo | Product |
| 8747902 | Mar 15, 2027 | in 9 mo | Product |
| 8883217 | Mar 15, 2027 | in 9 mo | Product |
| 9675703 | Mar 15, 2027 | in 9 mo | Product |
| 8337890 | Mar 15, 2027 | in 9 mo | Product |
| 9675704 | Mar 15, 2027 | in 9 mo | Product |
| 8062667 | Mar 29, 2029 | in 2 yr 10 mo | Product |
| 11590228 | Sep 07, 2036 | in 10 yr 4 mo | ProductU-3538 |
| 11590081 | Sep 24, 2038 | in 12 yr 5 mo | ProductU-3538 |
| 12458592 | Feb 11, 2040 | in 13 yr 10 mo | U-3538 |
Amphetamine; amphetamine aspartate/dextroamphetamine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
