suvorexant · Merck Sharp Dohme · NDA 204569
Belsomra
Earliest generic entry, as listed · earliest of 4 marketed strengths
29 May 2033
Blocked by patent: US 10098892, US 11980623, US 12599610.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10098892 | drug product · sets the listed date | 29 May 2033 |
| US 11980623 | drug product · sets the listed date | 29 May 2033 |
| US 12599610 | drug product · sets the listed date | 29 May 2033 |
| US 7951797 | drug substance, drug product, use U-620 | 20 Nov 2029 |
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
- Generic tentatively approved · ANDA 219386, Hetero Labs Ltd Unit Iii · 204569-001Tentative approval 22 Dec 2025Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204569 · 001 · RLD | tablet, oral | 5MG | 29 May 2033 |
| 204569 · 002 · RLD | tablet, oral | 10MG | 29 May 2033 |
| 204569 · 003 · RLD | tablet, oral | 15MG | 29 May 2033 |
| 204569 · 004 · RLD | tablet, oral | 20MG | 29 May 2033 |