Orange Book product · Brand (NDA)
CRENESSITY
CRINECERFONT
At a glance
Dec 13, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2024
1 yr 6 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 13, 2029
in 3 yr 6 mo
Exclusivity ends · ODE-503
Orphan-drug exclusivity (7 years)
Dec 13, 2031
in 5 yr 7 mo
Patent 10905690 expires
Listed method-of-use patent (U-4049) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11311544 expires
Listed method-of-use patent (U-4049) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 11730739 expires
Listed method-of-use patent (U-4049) expiration.
Jan 21, 2035
in 8 yr 9 mo
Patent 12128033 expires
Listed drug substance patent expiration.
Jun 09, 2041
in 15 yr 2 mo
Patent 12582634 expires
Listed drug substance patent expiration.
Jan 12, 2043
in 16 yr 10 mo
Pharmaceutical detail
Active ingredient
CRINECERFONT
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 218808
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)
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 |
