FDA Orange Book
Is there a generic for Auvelity?
Auvelity contains dextromethorphan and bupropion. 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 Auvelity (dextromethorphan and bupropion). The Orange Book shows its last listed patent expires November 28, 2043 and its last listed exclusivity ends April 30, 2029.
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Auvelity products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 105MG;30MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 105MG;45MG | Marketed (Rx) | None | 0 | None |
NDA 215430, held by AXSOME THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Auvelity patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8569328 | July 18, 2032 | Drug product | U-4516 | 215430 |
| 8569328 | July 18, 2032 | Drug product | U-3419 | 215430 |
| 9968568 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9168234 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10080727 | November 5, 2034 | Method of use | U-4520 | 215430 |
| 11590124 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 11291638 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11007189 | November 5, 2034 | Method of use | U-4516 | 215430 |
| 9700528 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11253492 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 9861595 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9700553 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9486450 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9370513 | November 5, 2034 | Method of use | U-4520 | 215430 |
| 9375429 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9314462 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9457023 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11207281 | November 5, 2034 | Method of use | U-4537 | 215430 |
| 10092560 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10780066 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9198905 | November 5, 2034 | Method of use | U-4520 | 215430 |
| 9205083 | November 5, 2034 | Method of use | U-4520 | 215430 |
| 9707191 | November 5, 2034 | Method of use | U-4522 | 215430 |
| 10058518 | November 5, 2034 | Method of use | U-4522 | 215430 |
| 11571417 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 10105361 | November 5, 2034 | Method of use | U-4522 | 215430 |
| 10251879 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11285146 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11273134 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11273133 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 11298352 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11344544 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11426370 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 11382874 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11234946 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 9763932 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11617747 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 11285118 | November 5, 2034 | Method of use | U-4526 | 215430 |
| 11419867 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11291665 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9421176 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9408815 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9238032 | November 5, 2034 | Method of use | U-4520 | 215430 |
| 9474731 | November 5, 2034 | Method of use | U-4520 | 215430 |
| 9457025 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9867819 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10092561 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 9278095 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10512643 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10463634 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10881624 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 10064857 | November 5, 2034 | Method of use | U-4517 | 215430 |
| 11524008 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 11524007 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 11517542 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 11517543 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 11510918 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 11382874 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 11364233 | November 5, 2034 | Method of use | U-3419 | 215430 |
| 9457025 | November 5, 2034 | Method of use | U-3419 | 215430 |
Showing 60 of 212 listed patents.
Auvelity exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-913 | New indication | April 30, 2029 | 215430 |
Auvelity NDC codes
Questions
Is there a generic for Auvelity?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Auvelity (dextromethorphan and bupropion). The Orange Book shows its last listed patent expires November 28, 2043 and its last listed exclusivity ends April 30, 2029.
What is the generic name for Auvelity?
The active ingredient in Auvelity is dextromethorphan and bupropion, per the FDA Orange Book.
When does the Auvelity patent expire?
The last patent listed for Auvelity in the Orange Book expires November 28, 2043. 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.