FDA Orange Book · active-ingredient family
Solriamfetol hydrochloride
Solriamfetol hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SUNOSI · NDA 211230
1
Brand (NDA)
0
Generics (ANDA)
42
Listed patents
2
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUNOSIRLD×2 | AXSOME MALTA | NDA 211230 | — | Jun 17, 2019 |
Marketing exclusivity (2)
- ODE-254Orphan-drug exclusivity (7 years)
Jun 17, 2026
2 d ago
- ODE-254Orphan-drug exclusivity (7 years)
Jun 17, 2026
2 d ago
Listed patents (42)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9604917 | Jun 07, 2026 | 12 d ago | U-2548 |
| 10351517 | Jun 07, 2026 | 12 d ago | U-2548 |
| 12209059 | Jun 07, 2026 | 12 d ago | U-2548 |
| 11753368 | Jun 07, 2026 | 12 d ago | U-2548 |
| 8877806 | Jun 07, 2026 | 12 d ago | U-2548 |
| 8440715 | Jun 11, 2031 | in 5 yr 1 mo | U-2548 |
| 10512609 | Sep 05, 2037 | in 11 yr 5 mo | U-2548 |
| 12390419 | Sep 05, 2037 | in 11 yr 5 mo | ProductU-2548 |
| 11998639 | Sep 05, 2037 | in 11 yr 5 mo | ProductU-2548 |
| 11439597 | Sep 05, 2037 | in 11 yr 5 mo | Product |
| 10195151 | Sep 05, 2037 | in 11 yr 5 mo | Product |
| 10912754 | Jun 01, 2038 | in 12 yr 2 mo | U-3082 |
| 10959976 | Jun 01, 2038 | in 12 yr 2 mo | U-3151 |
| 11648232 | Jun 01, 2038 | in 12 yr 2 mo | U-3602 |
| 11865098 | Jun 01, 2038 | in 12 yr 2 mo | U-2548 |
| 12384743 | Nov 01, 2038 | in 12 yr 7 mo | SubstanceProductU-2548 |
| 11560354 | Mar 06, 2039 | in 12 yr 11 mo | ProductU-3520 |
| 11160779 | Mar 19, 2040 | in 13 yr 11 mo | U-3521 |
| 12318362 | Mar 19, 2040 | in 13 yr 11 mo | U-3765 |
| 12194016 | Mar 19, 2040 | in 13 yr 11 mo | U-4106 |
| 10940133 | Mar 19, 2040 | in 13 yr 11 mo | U-3099 |
| 11839599 | Mar 19, 2040 | in 13 yr 11 mo | U-3764 |
| 11839598 | Mar 19, 2040 | in 13 yr 11 mo | U-3765 |
| 11850226 | Mar 19, 2040 | in 13 yr 11 mo | U-3775 |
| 11850227 | Mar 19, 2040 | in 13 yr 11 mo | U-3775 |
| 11850228 | Mar 19, 2040 | in 13 yr 11 mo | U-3775 |
| 11857528 | Mar 19, 2040 | in 13 yr 11 mo | U-3521 |
| 11986455 | Mar 19, 2040 | in 13 yr 11 mo | U-3521 |
| 11986454 | Mar 19, 2040 | in 13 yr 11 mo | U-3775 |
| 11969404 | Mar 19, 2040 | in 13 yr 11 mo | U-3892 |
| 12064411 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 12090126 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 12263145 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 11793776 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 11771667 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 11771666 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 11779554 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 12036194 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 11872203 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 11872204 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 12005036 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
| 12102609 | Dec 30, 2042 | in 16 yr 9 mo | U-3693 |
Solriamfetol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
