solriamfetol hydrochloride · Axsome Malta · NDA 211230
Sunosi
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Dec 2042
Blocked by patent: US 11771666, US 11771667, US 11779554, US 11793776, US 11872203, US 11872204, US 12005036, US 12036194, US 12064411, US 12090126, US 12102609, US 12263145. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 37 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11771666 | use U-3693 | 30 Dec 2042 |
| US 11771667 | use U-3693 | 30 Dec 2042 |
| US 11779554 | use U-3693 | 30 Dec 2042 |
| US 11793776 | use U-3693 | 30 Dec 2042 |
| US 11872203 | use U-3693 | 30 Dec 2042 |
| US 11872204 | use U-3693 | 30 Dec 2042 |
| US 12005036 | use U-3693 | 30 Dec 2042 |
| US 12036194 | use U-3693 | 30 Dec 2042 |
| US 12064411 | use U-3693 | 30 Dec 2042 |
| US 12090126 | use U-3693 | 30 Dec 2042 |
| US 12102609 | use U-3693 | 30 Dec 2042 |
| US 12263145 | use U-3693 | 30 Dec 2042 |
| US 10940133 | use U-3099 | 19 Mar 2040 |
| US 11160779 | use U-3521 | 19 Mar 2040 |
| US 11839598 | use U-3765 | 19 Mar 2040 |
| US 11839599 | use U-3764 | 19 Mar 2040 |
| US 11850226 | use U-3775 | 19 Mar 2040 |
| US 11850227 | use U-3775 | 19 Mar 2040 |
| US 11850228 | use U-3775 | 19 Mar 2040 |
| US 11857528 | use U-3521 | 19 Mar 2040 |
| US 11969404 | use U-3892 | 19 Mar 2040 |
| US 11986454 | use U-3775 | 19 Mar 2040 |
| US 11986455 | use U-3521 | 19 Mar 2040 |
| US 12194016 | use U-4106 | 19 Mar 2040 |
| US 12318362 | use U-3765 | 19 Mar 2040 |
| US 11560354 | product, use U-3520 | 6 Mar 2039 |
| US 12384743 | substance, product, use U-2548 | 1 Nov 2038 |
| US 10912754 | use U-3082 | 1 Jun 2038 |
| US 10959976 | use U-3151 | 1 Jun 2038 |
| US 11648232 | use U-3602 | 1 Jun 2038 |
| US 11865098 | use U-2548 | 1 Jun 2038 |
| US 10195151 | product | 5 Sep 2037 |
| US 10512609 | use U-2548 | 5 Sep 2037 |
| US 11439597 | product | 5 Sep 2037 |
| US 11998639 | product, use U-2548 | 5 Sep 2037 |
| US 12390419 | product, use U-2548 | 5 Sep 2037 |
| US 8440715 | use U-2548 | 11 Jun 2031 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic tentatively approved · 211230-00129 Sep 2026
- 25 Oct 2026Generic approved · 211230-0016 Oct 2026
- 25 Oct 2026First generic approved · 211230-00117 Jun 2026
- 25 Oct 2026Generic approved · 211230-00117 Jun 2026
- 25 Oct 2026First generic approved · 211230-00117 Jun 2026
- 25 Oct 2026Generic approved · 211230-00117 Jun 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211230 · 001 · RLD | tablet, oral | EQ 75MG BASE | 30 Dec 2042 |
| 211230 · 002 · RLD | tablet, oral | EQ 150MG BASE | 30 Dec 2042 |
Expired or delisted (6)
- US 10351517 · use U-2548 · 7 Jun 2026
- US 11753368 · use U-2548 · 7 Jun 2026
- US 12209059 · use U-2548 · 7 Jun 2026
- US 8877806 · use U-2548 · 7 Jun 2026
- US 9604917 · use U-2548 · 7 Jun 2026
- ODE-254 · 17 Jun 2026