FDA Orange Book · active-ingredient family
Paltusotine hydrochloride
Paltusotine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PALSONIFY · NDA 219070
1
Brand (NDA)
0
Generics (ANDA)
9
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PALSONIFYRLD×2 | CRINETICS | NDA 219070 | — | Sep 25, 2025 |
Marketing exclusivity (4)
- 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
- 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 |
|---|---|---|---|
| 11414397 | Jul 12, 2037 | in 11 yr 3 mo | SubstanceProductU-4283 |
| 10875839 | Jul 12, 2037 | in 11 yr 3 mo | U-4283 |
| 10597377 | Jul 12, 2037 | in 11 yr 3 mo | SubstanceProductU-4283 |
| 10351547 | 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 |
| 11957674 | Sep 07, 2041 | in 15 yr 5 mo | U-4283 |
| 11266641 | Sep 07, 2041 | in 15 yr 5 mo | ProductU-4283 |
| 12208092 | Mar 25, 2044 | in 18 yr | U-4282 |
Paltusotine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
