FDA Orange Book
Is there a generic for Cavhanza?
Cavhanza 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 Cavhanza (nilotinib). The Orange Book shows its last listed patent expires April 30, 2041.
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Cavhanza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, oral | 60MG | Marketed (Rx) | None | 0 | None |
| tablet, orally disintegrating, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 217379, held by CYCLE PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cavhanza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12016861 | January 29, 2041 | Method of use | U-4554 | 217379 |
| 12016861 | January 29, 2041 | Method of use | U-4555 | 217379 |
| 11389450 | January 29, 2041 | Method of use | U-4556 | 217379 |
| 11389450 | January 29, 2041 | Method of use | U-4557 | 217379 |
| 12029740 | January 29, 2041 | Drug product | None | 217379 |
| 11559485 | April 30, 2041 | Drug product | None | 217379 |
Cavhanza NDC codes
Questions
Is there a generic for Cavhanza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cavhanza (nilotinib). The Orange Book shows its last listed patent expires April 30, 2041.
What is the generic name for Cavhanza?
The active ingredient in Cavhanza is nilotinib, per the FDA Orange Book.
When does the Cavhanza patent expire?
The last patent listed for Cavhanza in the Orange Book expires April 30, 2041. 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.