Orange Book product · Brand (NDA)
QELBREE
VILOXAZINE HYDROCHLORIDE
At a glance
Apr 02, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 2021
5 yr 3 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 02, 2026
3 mo ago
Today
Patent 11324753 expires
Listed method-of-use patent (U-727) expiration.
Sep 04, 2029
in 3 yr 3 mo
Patent 11458143 expires
Listed method-of-use patent (U-727) expiration.
Sep 04, 2029
in 3 yr 3 mo
Patent 12121523 expires
Listed method-of-use patent (U-727) expiration.
Sep 04, 2029
in 3 yr 3 mo
Patent 9358204 expires
Listed drug product patent expiration.
Feb 07, 2033
in 6 yr 9 mo
Patent 9603853 expires
Listed method-of-use patent (U-727) expiration.
Feb 07, 2033
in 6 yr 9 mo
Patent 9662338 expires
Listed drug product patent expiration.
Apr 02, 2035
in 8 yr 11 mo
Pharmaceutical detail
Active ingredient
VILOXAZINE HYDROCHLORIDE
Strength
EQ 150MG BASE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 211964
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Apr 02, 2026
3 mo ago
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11324753 | Sep 04, 2029 | in 3 yr 3 mo | U-727 |
| 11458143 | Sep 04, 2029 | in 3 yr 3 mo | U-727 |
| 12121523 | Sep 04, 2029 | in 3 yr 3 mo | U-727 |
| 9358204 | Feb 07, 2033 | in 6 yr 9 mo | Product |
| 9603853 | Feb 07, 2033 | in 6 yr 9 mo | U-727 |
| 9662338 | Apr 02, 2035 | in 8 yr 11 mo | Product |
