FDA Orange Book
Is there a generic for Xelstrym?
Xelstrym contains 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 Xelstrym (dextroamphetamine). The Orange Book shows its last listed patent expires January 6, 2042.
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Xelstrym products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| system, transdermal | 13.5MG/9HR | Marketed (Rx) | None | 0 | None |
| system, transdermal | 18MG/9HR | Marketed (Rx) | None | 0 | None |
| system, transdermal | 4.5MG/9HR | Marketed (Rx) | None | 0 | None |
| system, transdermal | 9MG/9HR | Marketed (Rx) | None | 0 | None |
NDA 215401, held by NOVEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xelstrym patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9456993 | October 24, 2033 | Drug product | U-3340 | 215401 |
| 9474722 | October 24, 2033 | Drug product | None | 215401 |
| 12678504 | March 12, 2034 | Drug product | U-4583 | 215401 |
| 11559501 | January 6, 2042 | Drug product | None | 215401 |
Xelstrym NDC codes
Questions
Is there a generic for Xelstrym?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xelstrym (dextroamphetamine). The Orange Book shows its last listed patent expires January 6, 2042.
What is the generic name for Xelstrym?
The active ingredient in Xelstrym is dextroamphetamine, per the FDA Orange Book.
When does the Xelstrym patent expire?
The last patent listed for Xelstrym in the Orange Book expires January 6, 2042. 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 Xelstrym and Dextroamphetamine
- What is Xelstrym used for?FDA label uses
- Is Xelstrym a controlled substance?Schedule II
- What is Dextroamphetamine used for?FDA label uses
- Is Dextroamphetamine a controlled substance?Schedule II
- Generic for Dexedrine SpansuleFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 68968-0205Xelstrym NDC record
- NDC 68968-0210Xelstrym NDC record
- NDC 68968-0215Xelstrym NDC record
- Schedule II drugs listDEA schedule