FDA Orange Book
Is there a generic for Qelbree?
Qelbree contains viloxazine. 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 Qelbree (viloxazine). The Orange Book shows its last listed patent expires April 2, 2035 and its last listed exclusivity ends April 2, 2026.
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Qelbree products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, extended release, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 211964, held by SUPERNUS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Qelbree patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12121523 | September 4, 2029 | Method of use | U-727 | 211964 |
| 11458143 | September 4, 2029 | Method of use | U-727 | 211964 |
| 11324753 | September 4, 2029 | Method of use | U-727 | 211964 |
| 9603853 | February 7, 2033 | Method of use | U-727 | 211964 |
| 9358204 | February 7, 2033 | Drug product | None | 211964 |
| 9662338 | April 2, 2035 | Drug product | None | 211964 |
Qelbree exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 2, 2026 | 211964 |
Qelbree NDC codes
Questions
Is there a generic for Qelbree?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Qelbree (viloxazine). The Orange Book shows its last listed patent expires April 2, 2035 and its last listed exclusivity ends April 2, 2026.
What is the generic name for Qelbree?
The active ingredient in Qelbree is viloxazine, per the FDA Orange Book.
When does the Qelbree patent expire?
The last patent listed for Qelbree in the Orange Book expires April 2, 2035. 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.