FDA Orange Book
Is there a generic for Danziten?
Danziten contains nilotinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Danziten (nilotinib). The Orange Book shows its last listed patent expires February 18, 2040.
Run it in Rivvi
Map Danziten and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Danziten products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 71MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 95MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219293, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Danziten patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11793809 | February 18, 2040 | Drug product | None | 219293 |
| 10874671 | February 18, 2040 | Drug product | None | 219293 |
| 12403140 | February 18, 2040 | Drug product | None | 219293 |
| 12629369 | February 18, 2040 | Drug product | None | 219293 |
Danziten NDC codes
Questions
Is there a generic for Danziten?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Danziten (nilotinib). The Orange Book shows its last listed patent expires February 18, 2040.
What is the generic name for Danziten?
The active ingredient in Danziten is nilotinib, per the FDA Orange Book.
When does the Danziten patent expire?
The last patent listed for Danziten in the Orange Book expires February 18, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.