FDA Orange Book
Is there a generic for Dyanavel XR?
Dyanavel XR contains amphetamine and amphetamine aspartate/dextroamphetamine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dyanavel XR (amphetamine and amphetamine aspartate/dextroamphetamine). The Orange Book shows its last listed patent expires February 11, 2040.
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Dyanavel XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, oral | 2MG/ML;EQ 0.5MG BASE/ML | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 12MG;EQ 3MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 16MG;EQ 4MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 4MG;EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 8MG;EQ 2MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208147, 210526, held by TRIS PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Dyanavel XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8597684 | March 15, 2027 | Drug product | None | 208147 |
| 10086087 | March 15, 2027 | Drug product | None | 208147 |
| 8747902 | March 15, 2027 | Drug product | None | 208147 |
| 8883217 | March 15, 2027 | Drug product | None | 208147 |
| 9675703 | March 15, 2027 | Drug product | None | 208147 |
| 8337890 | March 15, 2027 | Drug product | None | 210526 |
| 9675704 | March 15, 2027 | Drug product | None | 210526 |
| 8062667 | March 29, 2029 | Drug product | None | 208147 |
| 11590228 | September 7, 2036 | Drug product | U-3538 | 208147 |
| 11590081 | September 24, 2038 | Drug product | U-3538 | 210526 |
| 12734132 | September 24, 2038 | Method of use | U-3538 | 210526 |
| 12458592 | February 11, 2040 | Method of use | U-3538 | 210526 |
Dyanavel XR NDC codes
Questions
Is there a generic for Dyanavel XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dyanavel XR (amphetamine and amphetamine aspartate/dextroamphetamine). The Orange Book shows its last listed patent expires February 11, 2040.
What is the generic name for Dyanavel XR?
The active ingredient in Dyanavel XR is amphetamine and amphetamine aspartate/dextroamphetamine, per the FDA Orange Book.
When does the Dyanavel XR patent expire?
The last patent listed for Dyanavel XR in the Orange Book expires February 11, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Dyanavel XR and Amphetamine and Amphetamine Aspartate/dextroamphetamine
- What is Dyanavel XR used for?FDA label uses
- Is Dyanavel XR a controlled substance?Schedule II
- What is Amphetamine used for?FDA label uses
- Is Amphetamine a controlled substance?Schedule II
- Generic for Adzenys XR-ODTFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 24478-102Dyanavel XR NDC record
- NDC 24478-106Dyanavel XR NDC record
- NDC 24478-108Dyanavel XR NDC record
- Schedule II drugs listDEA schedule