FDA Orange Book
Generic for Sunosi
Sunosi contains solriamfetol. 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
Yes. The generic name for Sunosi is solriamfetol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Sunosi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Sunosi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | EQ 75MG BASE | Marketed (Rx) | AB | 3 | AB |
NDA 211230, held by AXSOME MALTA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic solriamfetol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 218722 | AB (A-rated, therapeutically equivalent) | June 17, 2026 | EQ 150MG BASE, EQ 75MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 218016 | AB (A-rated, therapeutically equivalent) | June 17, 2026 | EQ 150MG BASE, EQ 75MG BASE |
| AUROBINDO PHARMA LTD | 218725 | AB (A-rated, therapeutically equivalent) | October 6, 2026 | EQ 150MG BASE, EQ 75MG BASE |
Sunosi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9604917 | June 7, 2026 | Method of use | U-2548 | 211230 |
| 10351517 | June 7, 2026 | Method of use | U-2548 | 211230 |
| 12209059 | June 7, 2026 | Method of use | U-2548 | 211230 |
| 11753368 | June 7, 2026 | Method of use | U-2548 | 211230 |
| 8877806 | June 7, 2026 | Method of use | U-2548 | 211230 |
| 8440715 | June 11, 2031 | Method of use | U-2548 | 211230 |
| 10512609 | September 5, 2037 | Method of use | U-2548 | 211230 |
| 12390419 | September 5, 2037 | Drug product | U-2548 | 211230 |
| 11998639 | September 5, 2037 | Drug product | U-2548 | 211230 |
| 11439597 | September 5, 2037 | Drug product | None | 211230 |
| 10195151 | September 5, 2037 | Drug product | None | 211230 |
| 10912754 | June 1, 2038 | Method of use | U-3082 | 211230 |
| 10959976 | June 1, 2038 | Method of use | U-3151 | 211230 |
| 11648232 | June 1, 2038 | Method of use | U-3602 | 211230 |
| 11865098 | June 1, 2038 | Method of use | U-2548 | 211230 |
| 12384743 | November 1, 2038 | Drug substance, Drug product | U-2548 | 211230 |
| 11560354 | March 6, 2039 | Drug product | U-3520 | 211230 |
| 11160779 | March 19, 2040 | Method of use | U-3521 | 211230 |
| 12318362 | March 19, 2040 | Method of use | U-3765 | 211230 |
| 12194016 | March 19, 2040 | Method of use | U-4106 | 211230 |
| 10940133 | March 19, 2040 | Method of use | U-3099 | 211230 |
| 11839599 | March 19, 2040 | Method of use | U-3764 | 211230 |
| 11839598 | March 19, 2040 | Method of use | U-3765 | 211230 |
| 11850226 | March 19, 2040 | Method of use | U-3775 | 211230 |
| 11850227 | March 19, 2040 | Method of use | U-3775 | 211230 |
| 11850228 | March 19, 2040 | Method of use | U-3775 | 211230 |
| 11857528 | March 19, 2040 | Method of use | U-3521 | 211230 |
| 11986455 | March 19, 2040 | Method of use | U-3521 | 211230 |
| 11986454 | March 19, 2040 | Method of use | U-3775 | 211230 |
| 11969404 | March 19, 2040 | Method of use | U-3892 | 211230 |
| 12064411 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 12090126 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 12263145 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 11793776 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 11771667 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 11771666 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 11779554 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 12036194 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 11872203 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 11872204 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 12005036 | December 30, 2042 | Method of use | U-3693 | 211230 |
| 12102609 | December 30, 2042 | Method of use | U-3693 | 211230 |
Sunosi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-254 | Orphan drug exclusivity | June 17, 2026 | 211230 |
Sunosi NDC codes
Questions
Is there a generic for Sunosi?
Yes. The generic name for Sunosi is solriamfetol. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Sunosi?
The active ingredient in Sunosi is solriamfetol, per the FDA Orange Book.
When does the Sunosi patent expire?
The last patent listed for Sunosi in the Orange Book expires December 30, 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.