FDA Orange Book · active-ingredient family
Nilotinib tartrate
Nilotinib tartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DANZITEN · NDA 219293
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DANZITENRLD×2 | AZURITY | NDA 219293 | — | Nov 07, 2024 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11793809 | Feb 18, 2040 | in 13 yr 10 mo | Product |
| 10874671 | Feb 18, 2040 | in 13 yr 10 mo | Product |
| 12403140 | Feb 18, 2040 | in 13 yr 10 mo | Product |
| 12629369 | Feb 18, 2040 | in 13 yr 10 mo | Product |
Nilotinib tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
