Orange Book product · Brand (NDA)
INQOVI
CEDAZURIDINE; DECITABINE
At a glance
Jul 07, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 07, 2020
6 yr ago
Today
Exclusivity ends · ODE-316
Orphan-drug exclusivity (7 years)
Jul 07, 2027
in 1 yr 1 mo
Patent 8618075 expires
Listed method-of-use patent (U-2864) expiration.
Oct 16, 2028
in 2 yr 4 mo
Patent 8618075 expires
Listed method-of-use patent (U-2867) expiration.
Oct 16, 2028
in 2 yr 4 mo
Patent 9567363 expires
Listed drug substance patent expiration.
Oct 16, 2028
in 2 yr 4 mo
Patent 8268800 expires
Listed drug substance patent expiration.
Aug 22, 2030
in 4 yr 3 mo
Patent 8268800 expires
Listed drug substance patent expiration.
Aug 22, 2030
in 4 yr 3 mo
Patent 8268800 expires
Listed drug substance patent expiration.
Aug 22, 2030
in 4 yr 3 mo
Patent 8268800 expires
Listed drug substance patent expiration.
Aug 22, 2030
in 4 yr 3 mo
Patent 12195496 expires
Listed drug product patent expiration.
Oct 07, 2040
in 14 yr 6 mo
Patent 11963971 expires
Listed drug product patent expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12239653 expires
Listed method-of-use patent (U-2865) expiration.
Feb 24, 2041
in 14 yr 11 mo
Patent 12239653 expires
Listed method-of-use patent (U-2866) expiration.
Feb 24, 2041
in 14 yr 11 mo
Pharmaceutical detail
Active ingredient
CEDAZURIDINE; DECITABINE
Strength
100MG;35MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212576
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 (1)
- ODE-316Orphan-drug exclusivity (7 years)
Jul 07, 2027
in 1 yr 1 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8618075 | Oct 16, 2028 | in 2 yr 4 mo | U-2864 |
| 8618075 | Oct 16, 2028 | in 2 yr 4 mo | U-2867 |
| 9567363 | Oct 16, 2028 | in 2 yr 4 mo | Substance |
| 8268800 | Aug 22, 2030 | in 4 yr 3 mo | SubstanceU-2866 |
| 8268800 | Aug 22, 2030 | in 4 yr 3 mo | SubstanceU-2865 |
| 8268800 | Aug 22, 2030 | in 4 yr 3 mo | SubstanceU-2864 |
| 8268800 | Aug 22, 2030 | in 4 yr 3 mo | SubstanceU-2867 |
| 12195496 | Oct 07, 2040 | in 14 yr 6 mo | Product |
| 11963971 | Feb 24, 2041 | in 14 yr 11 mo | Product |
| 12239653 | Feb 24, 2041 | in 14 yr 11 mo | U-2865 |
| 12239653 | Feb 24, 2041 | in 14 yr 11 mo | U-2866 |
