Orange Book product · Brand (NDA)
PALSONIFY
PALTUSOTINE HYDROCHLORIDE
At a glance
Sep 25, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2025
9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 25, 2030
in 4 yr 4 mo
Exclusivity ends · ODE-537
Orphan-drug exclusivity (7 years)
Sep 25, 2032
in 6 yr 4 mo
Patent 10351547 expires
Listed drug substance patent expiration.
Jul 12, 2037
in 11 yr 3 mo
Patent 10597377 expires
Listed drug substance patent expiration.
Jul 12, 2037
in 11 yr 3 mo
Patent 10875839 expires
Listed method-of-use patent (U-4283) expiration.
Jul 12, 2037
in 11 yr 3 mo
Patent 11414397 expires
Listed drug substance patent expiration.
Jul 12, 2037
in 11 yr 3 mo
Patent 9896432 expires
Listed drug substance patent expiration.
Jul 12, 2037
in 11 yr 3 mo
Patent 10464918 expires
Listed drug substance patent expiration.
Jan 16, 2039
in 12 yr 9 mo
Patent 11266641 expires
Listed drug product patent expiration.
Sep 07, 2041
in 15 yr 5 mo
Patent 11957674 expires
Listed method-of-use patent (U-4283) expiration.
Sep 07, 2041
in 15 yr 5 mo
Patent 12208092 expires
Listed method-of-use patent (U-4282) expiration.
Mar 25, 2044
in 18 yr
Pharmaceutical detail
Active ingredient
PALTUSOTINE HYDROCHLORIDE
Strength
EQ 20MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219070
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)
- NCENew chemical entity exclusivity (5 years)
Sep 25, 2030
in 4 yr 4 mo
- ODE-537Orphan-drug exclusivity (7 years)
Sep 25, 2032
in 6 yr 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10351547 | Jul 12, 2037 | in 11 yr 3 mo | SubstanceProductU-4283 |
| 10597377 | Jul 12, 2037 | in 11 yr 3 mo | SubstanceProductU-4283 |
| 10875839 | Jul 12, 2037 | in 11 yr 3 mo | U-4283 |
| 11414397 | Jul 12, 2037 | in 11 yr 3 mo | SubstanceProductU-4283 |
| 9896432 | Jul 12, 2037 | in 11 yr 3 mo | SubstanceProductU-4283 |
| 10464918 | Jan 16, 2039 | in 12 yr 9 mo | Substance |
| 11266641 | Sep 07, 2041 | in 15 yr 5 mo | ProductU-4283 |
| 11957674 | Sep 07, 2041 | in 15 yr 5 mo | U-4283 |
| 12208092 | Mar 25, 2044 | in 18 yr | U-4282 |
