FDA Orange Book · active-ingredient family
Axitinib
Axitinib is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:INLYTA · NDA 202324
1
Brand (NDA)
1
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INLYTARLD×2 | PF PRISM CV | NDA 202324 | — | Jan 27, 2012 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AXITINIB×2 | APOTEX | ANDA 211650 | — | Oct 30, 2025 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8791140 | Dec 14, 2030 | in 4 yr 7 mo | Substance |
| 8791140*PED | Jun 14, 2031 | in 5 yr 1 mo | |
| 12534530 | Feb 03, 2035 | in 8 yr 9 mo | U-4411 |
| 10570202 | Feb 03, 2035 | in 8 yr 9 mo | U-2844 |
| 12534530*PED | Aug 03, 2035 | in 9 yr 3 mo | |
| 10570202*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 |
Axitinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
