Orange Book product · Brand (NDA)
SOHONOS
PALOVAROTENE
At a glance
Aug 16, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 16, 2023
2 yr 11 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
Exclusivity ends · ODE-439
Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
Patent 10292954 expires
Listed method-of-use patent (U-3676) expiration.
Aug 31, 2031
in 5 yr 3 mo
Patent 12023312 expires
Listed method-of-use patent (U-3966) expiration.
Aug 31, 2031
in 5 yr 3 mo
Patent 9314439 expires
Listed method-of-use patent (U-3676) expiration.
Aug 31, 2031
in 5 yr 3 mo
Patent 9789074 expires
Listed method-of-use patent (U-3676) expiration.
Aug 31, 2031
in 5 yr 3 mo
Patent 10864194 expires
Listed method-of-use patent (U-3676) expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 11622959 expires
Listed method-of-use patent (U-3676) expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 12138245 expires
Listed method-of-use patent (U-4031) expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 12201614 expires
Listed method-of-use patent (U-4031) expiration.
Jun 08, 2037
in 11 yr 2 mo
Patent 12458626 expires
Listed method-of-use patent (U-3676) expiration.
Jun 08, 2037
in 11 yr 2 mo
Pharmaceutical detail
Active ingredient
PALOVAROTENE
Strength
5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215559
Product number
004
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)
- NCENew chemical entity exclusivity (5 years)
Aug 16, 2028
in 2 yr 2 mo
- ODE-439Orphan-drug exclusivity (7 years)
Aug 16, 2030
in 4 yr 3 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10292954 | Aug 31, 2031 | in 5 yr 3 mo | U-3676 |
| 12023312 | Aug 31, 2031 | in 5 yr 3 mo | U-3966 |
| 9314439 | Aug 31, 2031 | in 5 yr 3 mo | U-3676 |
| 9789074 | Aug 31, 2031 | in 5 yr 3 mo | U-3676 |
| 10864194 | Jun 08, 2037 | in 11 yr 2 mo | U-3676 |
| 11622959 | Jun 08, 2037 | in 11 yr 2 mo | U-3676 |
| 12138245 | Jun 08, 2037 | in 11 yr 2 mo | U-4031 |
| 12201614 | Jun 08, 2037 | in 11 yr 2 mo | U-4031 |
| 12458626 | Jun 08, 2037 | in 11 yr 2 mo | U-3676 |
