FDA Orange Book · active-ingredient family
Danicopan
Danicopan is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:VOYDEYA · NDA 218037
1
Brand (NDA)
0
Generics (ANDA)
2
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VOYDEYARLD×2 | ALEXION PHARMS INC | NDA 218037 | — | Mar 29, 2024 |
Marketing exclusivity (4)
- 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
- 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 |
Danicopan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
