Orange Book product · Brand (NDA)
VOYDEYA
DANICOPAN
At a glance
Mar 29, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2024
2 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 29, 2029
in 2 yr 10 mo
Exclusivity ends · ODE-476
Orphan-drug exclusivity (7 years)
Mar 29, 2031
in 4 yr 10 mo
Patent 9796741 expires
Listed drug substance patent expiration.
Feb 25, 2035
in 8 yr 10 mo
Patent 12076319 expires
Listed method-of-use patent (U-3933) expiration.
Aug 02, 2038
in 12 yr 4 mo
Pharmaceutical detail
Active ingredient
DANICOPAN
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218037
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)
Mar 29, 2029
in 2 yr 10 mo
- ODE-476Orphan-drug exclusivity (7 years)
Mar 29, 2031
in 4 yr 10 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9796741 | Feb 25, 2035 | in 8 yr 10 mo | SubstanceU-3933 |
| 12076319 | Aug 02, 2038 | in 12 yr 4 mo | U-3933 |
