FDA Orange Book
Is there a generic for Zykadia?
Zykadia contains ceritinib. 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 Zykadia (ceritinib). The Orange Book shows its last listed patent expires December 13, 2037.
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Zykadia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Discontinued | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
NDA 205755, 211225, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zykadia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7893074 | April 25, 2026 | Drug substance, Drug product | None | 205755 |
| 8377921 | November 20, 2027 | Method of use | U-1179 | 205755 |
| 8399450 | November 20, 2027 | Drug substance, Drug product | None | 205755 |
| 7964592 | April 29, 2028 | Drug substance, Drug product | None | 205755 |
| 8039479 | June 29, 2030 | Drug substance, Drug product | None | 205755 |
| 9309229 | January 18, 2032 | Drug substance, Drug product | None | 205755 |
| 8703787 | February 2, 2032 | Method of use | U-1179 | 205755 |
| 12357630 | December 13, 2037 | Method of use | U-3096 | 211225 |
Zykadia NDC codes
Questions
Is there a generic for Zykadia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zykadia (ceritinib). The Orange Book shows its last listed patent expires December 13, 2037.
What is the generic name for Zykadia?
The active ingredient in Zykadia is ceritinib, per the FDA Orange Book.
When does the Zykadia patent expire?
The last patent listed for Zykadia in the Orange Book expires December 13, 2037. 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.