Orange Book product · Brand (NDA)
TRINTELLIX
VORTIOXETINE HYDROBROMIDE
At a glance
Sep 30, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
20
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 2013
12 yr 11 mo ago
Patent 7144884 expires
Listed drug substance patent expiration.
Jun 17, 2026
2 d ago
Today
Exclusivity ends · M-232
New use / labeling-change exclusivity (3 years)
Aug 23, 2026
in 2 mo
Patent 7144884*PED expires
Listed listed patent expiration.
Dec 17, 2026
in 6 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Feb 23, 2027
in 8 mo
Patent 11458134 expires
Listed drug product patent expiration.
Jun 15, 2027
in 1 yr
Patent 8969355 expires
Listed method-of-use patent (U-1668) expiration.
Jun 15, 2027
in 1 yr
Patent 9125908 expires
Listed method-of-use patent (U-2309) expiration.
Jun 15, 2027
in 1 yr
Patent 9125909 expires
Listed method-of-use patent (U-2309) expiration.
Jun 15, 2027
in 1 yr
Patent 9125910 expires
Listed method-of-use patent (U-2309) expiration.
Jun 15, 2027
in 1 yr
Patent 9227946 expires
Listed method-of-use patent (U-1668) expiration.
Jun 15, 2027
in 1 yr
Patent 9861630 expires
Listed method-of-use patent (U-1668) expiration.
Jun 15, 2027
in 1 yr
Patent 11458134*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 8969355*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 9125908*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 9125909*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 9125910*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 9227946*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 9861630*PED expires
Listed listed patent expiration.
Dec 15, 2027
in 1 yr 6 mo
Patent 8722684 expires
Listed drug substance patent expiration.
Jun 30, 2031
in 5 yr 1 mo
Patent 8722684*PED expires
Listed listed patent expiration.
Dec 30, 2031
in 5 yr 7 mo
Patent 9278096 expires
Listed method-of-use patent (U-2436) expiration.
Mar 21, 2032
in 5 yr 10 mo
Patent 9278096*PED expires
Listed listed patent expiration.
Sep 21, 2032
in 6 yr 4 mo
Pharmaceutical detail
Active ingredient
VORTIOXETINE HYDROBROMIDE
Strength
EQ 5MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 204447
Product number
001
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 (2)
- M-232New use / labeling-change exclusivity (3 years)
Aug 23, 2026
in 2 mo
- PEDPediatric exclusivity (adds 6 months)
Feb 23, 2027
in 8 mo
Listed patents (20)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7144884 | Jun 17, 2026 | 2 d ago | SubstanceProductU-1439 |
| 7144884*PED | Dec 17, 2026 | in 6 mo | |
| 11458134 | Jun 15, 2027 | in 1 yr | ProductU-3463 |
| 8969355 | Jun 15, 2027 | in 1 yr | U-1668 |
| 9125908 | Jun 15, 2027 | in 1 yr | U-2309 |
| 9125909 | Jun 15, 2027 | in 1 yr | U-2309 |
| 9125910 | Jun 15, 2027 | in 1 yr | U-2309 |
| 9227946 | Jun 15, 2027 | in 1 yr | U-1668 |
| 9861630 | Jun 15, 2027 | in 1 yr | U-1668 |
| 11458134*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 8969355*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 9125908*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 9125909*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 9125910*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 9227946*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 9861630*PED | Dec 15, 2027 | in 1 yr 6 mo | |
| 8722684 | Jun 30, 2031 | in 5 yr 1 mo | SubstanceProduct |
| 8722684*PED | Dec 30, 2031 | in 5 yr 7 mo | |
| 9278096 | Mar 21, 2032 | in 5 yr 10 mo | U-2436 |
| 9278096*PED | Sep 21, 2032 | in 6 yr 4 mo |
