viloxazine hydrochloride · Supernus Pharms · NDA 211964
Qelbree
Earliest generic entry, as listed · earliest of 3 marketed strengths
2 Apr 2035
Blocked by patent: US 9662338.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9662338 | drug product · sets the listed date | 2 Apr 2035 |
| US 9358204 | drug product | 7 Feb 2033 |
| US 9603853 | use U-727 | 7 Feb 2033 |
| US 11324753 | use U-727 | 4 Sep 2029 |
| US 11458143 | use U-727 | 4 Sep 2029 |
| US 12121523 | use U-727 | 4 Sep 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 220326, Appco Pharma Llc · 211964-001Tentative approval 28 Apr 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 220376, Zenara Pharma Private Ltd · 211964-001Tentative approval 8 Oct 2026Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211964 · 001 · RLD | capsule, extended release, oral | EQ 100MG BASE | 2 Apr 2035 |
| 211964 · 002 · RLD | capsule, extended release, oral | EQ 150MG BASE | 2 Apr 2035 |
| 211964 · 003 · RLD | capsule, extended release, oral | EQ 200MG BASE | 2 Apr 2035 |
Expired or delisted (1)
- NCE · 2 Apr 2026