Orange Book product · Brand (NDA)
ZYKADIA
CERITINIB
At a glance
Mar 18, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
8
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 18, 2019
7 yr 4 mo ago
Patent 7893074 expires
Listed drug substance patent expiration.
Apr 25, 2026
2 mo ago
Today
Patent 8377921 expires
Listed method-of-use patent (U-1179) expiration.
Nov 20, 2027
in 1 yr 5 mo
Patent 8399450 expires
Listed drug substance patent expiration.
Nov 20, 2027
in 1 yr 5 mo
Patent 7964592 expires
Listed drug substance patent expiration.
Apr 29, 2028
in 1 yr 11 mo
Patent 8039479 expires
Listed drug substance patent expiration.
Jun 29, 2030
in 4 yr 1 mo
Patent 9309229 expires
Listed drug substance patent expiration.
Jan 18, 2032
in 5 yr 8 mo
Patent 8703787 expires
Listed method-of-use patent (U-1179) expiration.
Feb 02, 2032
in 5 yr 8 mo
Patent 12357630 expires
Listed method-of-use patent (U-3096) expiration.
Dec 13, 2037
in 11 yr 8 mo
Pharmaceutical detail
Active ingredient
CERITINIB
Strength
150MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 211225
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 (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7893074 | Apr 25, 2026 | 2 mo ago | SubstanceProduct |
| 8377921 | Nov 20, 2027 | in 1 yr 5 mo | U-1179 |
| 8399450 | Nov 20, 2027 | in 1 yr 5 mo | SubstanceProduct |
| 7964592 | Apr 29, 2028 | in 1 yr 11 mo | SubstanceProduct |
| 8039479 | Jun 29, 2030 | in 4 yr 1 mo | SubstanceProduct |
| 9309229 | Jan 18, 2032 | in 5 yr 8 mo | SubstanceProduct |
| 8703787 | Feb 02, 2032 | in 5 yr 8 mo | U-1179 |
| 12357630 | Dec 13, 2037 | in 11 yr 8 mo | U-3096 |
