Orange Book product · Brand (NDA)
NUPLAZID
PIMAVANSERIN TARTRATE
At a glance
Jun 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
9
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 10517860 expires
Listed method-of-use patent (U-1974) expiration.
Mar 23, 2037
in 10 yr 11 mo
Patent 10953000 expires
Listed method-of-use patent (U-1974) expiration.
Mar 23, 2037
in 10 yr 11 mo
Patent 10517860*PED expires
Listed listed patent expiration.
Sep 23, 2037
in 11 yr 5 mo
Patent 10953000*PED expires
Listed listed patent expiration.
Sep 23, 2037
in 11 yr 5 mo
Pharmaceutical detail
Active ingredient
PIMAVANSERIN TARTRATE
Strength
EQ 10MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 207318
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)
- 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 (9)
| 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 | |
| 10517860 | Mar 23, 2037 | in 10 yr 11 mo | U-1974 |
| 10953000 | Mar 23, 2037 | in 10 yr 11 mo | U-1974 |
| 10517860*PED | Sep 23, 2037 | in 11 yr 5 mo | |
| 10953000*PED | Sep 23, 2037 | in 11 yr 5 mo |
