Orange Book product · Brand (NDA)
XALKORI
CRIZOTINIB
At a glance
Aug 26, 2011
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 26, 2011
15 yr ago
Today
Patent 7825137 expires
Listed method-of-use patent (U-3403) expiration.
May 12, 2027
in 11 mo
Patent 7825137 expires
Listed method-of-use patent (U-3058) expiration.
May 12, 2027
in 11 mo
Patent 7825137 expires
Listed method-of-use patent (U-3057) expiration.
May 12, 2027
in 11 mo
Exclusivity ends · ODE-328
Orphan-drug exclusivity (7 years)
Jan 14, 2028
in 1 yr 7 mo
Exclusivity ends · ODE-407
Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Patent 7858643 expires
Listed drug substance patent expiration.
Oct 08, 2029
in 3 yr 4 mo
Patent 8217057 expires
Listed drug substance patent expiration.
Nov 06, 2029
in 3 yr 5 mo
Pharmaceutical detail
Active ingredient
CRIZOTINIB
Strength
250MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 202570
Product number
002
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)
- ODE-328Orphan-drug exclusivity (7 years)
Jan 14, 2028
in 1 yr 7 mo
- ODE-407Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7825137 | May 12, 2027 | in 11 mo | U-3403 |
| 7825137 | May 12, 2027 | in 11 mo | U-3058 |
| 7825137 | May 12, 2027 | in 11 mo | U-3057 |
| 7858643 | Oct 08, 2029 | in 3 yr 4 mo | SubstanceProduct |
| 8217057 | Nov 06, 2029 | in 3 yr 5 mo | SubstanceProduct |
