FDA Orange Book · active-ingredient family
Crinecerfont
Crinecerfont is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CRENESSITY · NDA 218808
2
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
8
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CRENESSITYRLD×3 | NEUROCRINE | NDA 218808 | — | Dec 13, 2024 | |
| CRENESSITYRLD | NEUROCRINE | NDA 218820 | — | Dec 13, 2024 |
Marketing exclusivity (8)
- NCENew chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
- ODE-503Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
- ODE-503Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
- ODE-503Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
- NCENew chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
- ODE-503Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10905690 | Jan 21, 2035 | in 8 yr 9 mo | U-4049 |
| 11311544 | Jan 21, 2035 | in 8 yr 9 mo | U-4049 |
| 11730739 | Jan 21, 2035 | in 8 yr 9 mo | U-4049 |
| 12128033 | Jun 09, 2041 | in 15 yr 2 mo | SubstanceU-4049 |
| 12582634 | Jan 12, 2043 | in 16 yr 10 mo | Substance |
Crinecerfont — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
