Orange Book product · Brand (NDA)
INLYTA
AXITINIB
At a glance
Jan 27, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 27, 2012
14 yr 7 mo ago
Today
Patent 8791140 expires
Listed drug substance patent expiration.
Dec 14, 2030
in 4 yr 7 mo
Patent 8791140*PED expires
Listed listed patent expiration.
Jun 14, 2031
in 5 yr 1 mo
Patent 10570202 expires
Listed method-of-use patent (U-2844) expiration.
Feb 03, 2035
in 8 yr 9 mo
Patent 12534530 expires
Listed method-of-use patent (U-4411) expiration.
Feb 03, 2035
in 8 yr 9 mo
Patent 12534530 expires
Listed method-of-use patent (U-4412) expiration.
Feb 03, 2035
in 8 yr 9 mo
Patent 10570202*PED expires
Listed listed patent expiration.
Aug 03, 2035
in 9 yr 3 mo
Patent 12534530*PED expires
Listed listed patent expiration.
Aug 03, 2035
in 9 yr 3 mo
Patent 10869924 expires
Listed method-of-use patent (U-3044) expiration.
Jan 12, 2037
in 10 yr 9 mo
Patent 10869924*PED expires
Listed listed patent expiration.
Jul 12, 2037
in 11 yr 3 mo
Pharmaceutical detail
Active ingredient
AXITINIB
Strength
1MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 202324
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 (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8791140 | Dec 14, 2030 | in 4 yr 7 mo | Substance |
| 8791140*PED | Jun 14, 2031 | in 5 yr 1 mo | |
| 10570202 | Feb 03, 2035 | in 8 yr 9 mo | U-2844 |
| 12534530 | Feb 03, 2035 | in 8 yr 9 mo | U-4411 |
| 12534530 | Feb 03, 2035 | in 8 yr 9 mo | U-4412 |
| 10570202*PED | Aug 03, 2035 | in 9 yr 3 mo | |
| 12534530*PED | Aug 03, 2035 | in 9 yr 3 mo | |
| 10869924 | Jan 12, 2037 | in 10 yr 9 mo | U-3044 |
| 10869924*PED | Jul 12, 2037 | in 11 yr 3 mo |
