Orange Book product · Brand (NDA)
XALKORI
CRIZOTINIB
At a glance
Sep 07, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 07, 2023
2 yr 10 mo ago
Today
Patent 7825137 expires
Listed method-of-use patent (U-3057) expiration.
May 12, 2027
in 11 mo
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 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
20MG
Dosage form
CAPSULE, PELLETS
Route
ORAL
TE code
Not listed
Application
NDA 217581
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7825137 | May 12, 2027 | in 11 mo | U-3057 |
| 7825137 | May 12, 2027 | in 11 mo | U-3403 |
| 7825137 | May 12, 2027 | in 11 mo | U-3058 |
| 7858643 | Oct 08, 2029 | in 3 yr 4 mo | SubstanceProduct |
| 8217057 | Nov 06, 2029 | in 3 yr 5 mo | Substance |
