Orange Book product · Brand (NDA)
TAVNEOS
AVACOPAN
At a glance
Oct 07, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 07, 2021
4 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 07, 2026
in 4 mo
Exclusivity ends · ODE-377
Orphan-drug exclusivity (7 years)
Oct 07, 2028
in 2 yr 4 mo
Patent 8445515 expires
Listed drug substance patent expiration.
Feb 03, 2031
in 4 yr 8 mo
Patent 8906938 expires
Listed drug substance patent expiration.
Jan 06, 2034
in 7 yr 8 mo
Patent 11603356 expires
Listed drug substance patent expiration.
Nov 27, 2039
in 13 yr 8 mo
Patent 11951214 expires
Listed drug product patent expiration.
Nov 27, 2039
in 13 yr 8 mo
Pharmaceutical detail
Active ingredient
AVACOPAN
Strength
10MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 214487
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
Oct 07, 2026
in 4 mo
- ODE-377Orphan-drug exclusivity (7 years)
Oct 07, 2028
in 2 yr 4 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8445515 | Feb 03, 2031 | in 4 yr 8 mo | SubstanceProduct |
| 8906938 | Jan 06, 2034 | in 7 yr 8 mo | SubstanceProduct |
| 11603356 | Nov 27, 2039 | in 13 yr 8 mo | SubstanceProductU-3558 |
| 11951214 | Nov 27, 2039 | in 13 yr 8 mo | Product |
