Orange Book product · Brand (NDA)
ODOMZO
SONIDEGIB PHOSPHATE
At a glance
Jul 24, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2015
11 yr 1 mo ago
Today
Patent 8178563 expires
Listed drug substance patent expiration.
Jul 24, 2029
in 3 yr 2 mo
Patent 8063043 expires
Listed drug substance patent expiration.
Sep 15, 2029
in 3 yr 3 mo
Patent 10266523 expires
Listed drug substance patent expiration.
Mar 30, 2036
in 9 yr 11 mo
Pharmaceutical detail
Active ingredient
SONIDEGIB PHOSPHATE
Strength
EQ 200MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 205266
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.
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8178563 | Jul 24, 2029 | in 3 yr 2 mo | SubstanceU-1722 |
| 8063043 | Sep 15, 2029 | in 3 yr 3 mo | SubstanceProduct |
| 10266523 | Mar 30, 2036 | in 9 yr 11 mo | SubstanceProduct |
