Orange Book product · Brand (NDA)
NUPLAZID
PIMAVANSERIN TARTRATE
At a glance
Jun 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 28, 2018
8 yr 1 mo ago
Today
Patent 7659285 expires
Listed method-of-use patent (U-1844) expiration.
Aug 24, 2026
in 2 mo
Patent 7732615 expires
Listed drug substance patent expiration.
Jun 03, 2028
in 2 yr
Patent 7732615*PED expires
Listed listed patent expiration.
Dec 03, 2028
in 2 yr 6 mo
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 27, 2029
in 3 yr 5 mo
Patent 7601740 expires
Listed drug substance patent expiration.
Apr 29, 2030
in 3 yr 11 mo
Patent 7601740*PED expires
Listed listed patent expiration.
Oct 29, 2030
in 4 yr 5 mo
Patent 10449185 expires
Listed drug product patent expiration.
Aug 27, 2038
in 12 yr 4 mo
Patent 10646480 expires
Listed drug product patent expiration.
Aug 27, 2038
in 12 yr 4 mo
Patent 10849891 expires
Listed drug product patent expiration.
Aug 27, 2038
in 12 yr 4 mo
Patent 11452721 expires
Listed drug product patent expiration.
Aug 27, 2038
in 12 yr 4 mo
Patent 10449185*PED expires
Listed listed patent expiration.
Feb 27, 2039
in 12 yr 11 mo
Patent 10646480*PED expires
Listed listed patent expiration.
Feb 27, 2039
in 12 yr 11 mo
Patent 10849891*PED expires
Listed listed patent expiration.
Feb 27, 2039
in 12 yr 11 mo
Patent 11452721*PED expires
Listed listed patent expiration.
Feb 27, 2039
in 12 yr 11 mo
Pharmaceutical detail
Active ingredient
PIMAVANSERIN TARTRATE
Strength
EQ 34MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 210793
Product number
001
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)
- M-14New use / labeling-change exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 27, 2029
in 3 yr 5 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7659285 | Aug 24, 2026 | in 2 mo | U-1844 |
| 7732615 | Jun 03, 2028 | in 2 yr | SubstanceProduct |
| 7732615*PED | Dec 03, 2028 | in 2 yr 6 mo | |
| 7601740 | Apr 29, 2030 | in 3 yr 11 mo | SubstanceProduct |
| 7601740*PED | Oct 29, 2030 | in 4 yr 5 mo | |
| 10449185 | Aug 27, 2038 | in 12 yr 4 mo | Product |
| 10646480 | Aug 27, 2038 | in 12 yr 4 mo | Product |
| 10849891 | Aug 27, 2038 | in 12 yr 4 mo | ProductU-1974 |
| 11452721 | Aug 27, 2038 | in 12 yr 4 mo | Product |
| 10449185*PED | Feb 27, 2039 | in 12 yr 11 mo | |
| 10646480*PED | Feb 27, 2039 | in 12 yr 11 mo | |
| 10849891*PED | Feb 27, 2039 | in 12 yr 11 mo | |
| 11452721*PED | Feb 27, 2039 | in 12 yr 11 mo |
