Orange Book product · Brand (NDA)
INGREZZA
VALBENAZINE TOSYLATE
At a glance
Oct 04, 2017
Approved
Brand (NDA)
Application
AB
TE code
33
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 04, 2017
8 yr 10 mo ago
Today
Exclusivity ends · I-925
New indication exclusivity (3 years)
Aug 18, 2026
in 2 mo
Patent 8357697 expires
Listed method-of-use patent (U-1995) expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 8357697 expires
Listed method-of-use patent (U-3055) expiration.
Nov 08, 2027
in 1 yr 5 mo
Exclusivity ends · ODE-440
Orphan-drug exclusivity (7 years)
Aug 18, 2030
in 4 yr 3 mo
Patent 8039627 expires
Listed drug substance patent expiration.
Apr 11, 2031
in 4 yr 11 mo
Patent 10065952 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10065952 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10844058 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10844058 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10851103 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10851103 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10851104 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10851104 expires
Listed drug substance patent expiration.
Oct 28, 2036
in 10 yr 6 mo
Patent 10906902 expires
Listed drug substance patent expiration.
Dec 22, 2036
in 10 yr 8 mo
Patent 10906903 expires
Listed drug substance patent expiration.
Dec 22, 2036
in 10 yr 8 mo
Patent 10919892 expires
Listed drug substance patent expiration.
Dec 22, 2036
in 10 yr 8 mo
Patent 10857137 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10857148 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10874648 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10874648 expires
Listed method-of-use patent (U-3046) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10874648 expires
Listed method-of-use patent (U-3055) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10912771 expires
Listed method-of-use patent (U-3055) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10912771 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10912771 expires
Listed method-of-use patent (U-3076) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10952997 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 10993941 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 11040029 expires
Listed method-of-use patent (U-1995) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 11439629 expires
Listed method-of-use patent (U-3055) expiration.
Oct 10, 2037
in 11 yr 6 mo
Patent 11026939 expires
Listed drug product patent expiration.
Sep 18, 2038
in 12 yr 5 mo
Patent 11026939 expires
Listed drug product patent expiration.
Sep 18, 2038
in 12 yr 5 mo
Patent 11311532 expires
Listed drug product patent expiration.
Sep 18, 2038
in 12 yr 5 mo
Patent 11311532 expires
Listed drug product patent expiration.
Sep 18, 2038
in 12 yr 5 mo
Patent 11654142 expires
Listed method-of-use patent (U-3055) expiration.
Nov 14, 2038
in 12 yr 7 mo
Patent 11026931 expires
Listed method-of-use patent (U-1995) expiration.
Aug 14, 2039
in 13 yr 4 mo
Patent 10940141 expires
Listed method-of-use patent (U-1995) expiration.
Aug 10, 2040
in 14 yr 4 mo
Pharmaceutical detail
Active ingredient
VALBENAZINE TOSYLATE
Strength
EQ 80MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 209241
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
- I-925New indication exclusivity (3 years)
Aug 18, 2026
in 2 mo
- ODE-440Orphan-drug exclusivity (7 years)
Aug 18, 2030
in 4 yr 3 mo
Listed patents (33)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8357697 | Nov 08, 2027 | in 1 yr 5 mo | U-1995 |
| 8357697 | Nov 08, 2027 | in 1 yr 5 mo | U-3055 |
| 8039627 | Apr 11, 2031 | in 4 yr 11 mo | SubstanceProduct |
| 10065952 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceProductU-1995 |
| 10065952 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceProductU-3055 |
| 10844058 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceProductU-1995 |
| 10844058 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceProductU-3055 |
| 10851103 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceProductU-1995 |
| 10851103 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceProductU-3055 |
| 10851104 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceU-1995 |
| 10851104 | Oct 28, 2036 | in 10 yr 6 mo | SubstanceU-3055 |
| 10906902 | Dec 22, 2036 | in 10 yr 8 mo | SubstanceProduct |
| 10906903 | Dec 22, 2036 | in 10 yr 8 mo | SubstanceProduct |
| 10919892 | Dec 22, 2036 | in 10 yr 8 mo | SubstanceProduct |
| 10857137 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 10857148 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 10874648 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 10874648 | Oct 10, 2037 | in 11 yr 6 mo | U-3046 |
| 10874648 | Oct 10, 2037 | in 11 yr 6 mo | U-3055 |
| 10912771 | Oct 10, 2037 | in 11 yr 6 mo | U-3055 |
| 10912771 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 10912771 | Oct 10, 2037 | in 11 yr 6 mo | U-3076 |
| 10952997 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 10993941 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 11040029 | Oct 10, 2037 | in 11 yr 6 mo | U-1995 |
| 11439629 | Oct 10, 2037 | in 11 yr 6 mo | U-3055 |
| 11026939 | Sep 18, 2038 | in 12 yr 5 mo | ProductU-3055 |
| 11026939 | Sep 18, 2038 | in 12 yr 5 mo | ProductU-1995 |
| 11311532 | Sep 18, 2038 | in 12 yr 5 mo | ProductU-1995 |
| 11311532 | Sep 18, 2038 | in 12 yr 5 mo | ProductU-3055 |
| 11654142 | Nov 14, 2038 | in 12 yr 7 mo | U-3055 |
| 11026931 | Aug 14, 2039 | in 13 yr 4 mo | U-1995 |
| 10940141 | Aug 10, 2040 | in 14 yr 4 mo | U-1995 |
