FDA Orange Book
Is there a generic for Xalkori?
Xalkori contains crizotinib. 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 Xalkori (crizotinib). The Orange Book shows its last listed patent expires November 6, 2029 and its last listed exclusivity ends July 14, 2029.
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Xalkori products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, pellets, oral | 150MG | Marketed (Rx) | None | 0 | None |
| capsule, pellets, oral | 20MG | Marketed (Rx) | None | 0 | None |
| capsule, pellets, oral | 50MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 200MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 250MG | Marketed (Rx) | None | 0 | None |
NDA 217581, 202570, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Xalkori patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7825137 | May 12, 2027 | Method of use | U-3057 | 217581 |
| 7825137 | May 12, 2027 | Method of use | U-3403 | 217581 |
| 7825137 | May 12, 2027 | Method of use | U-3058 | 217581 |
| 7858643 | October 8, 2029 | Drug substance, Drug product | None | 217581 |
| 8217057 | November 6, 2029 | Drug substance | None | 217581 |
Xalkori exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-328 | Orphan drug exclusivity | January 14, 2028 | 202570 |
| ODE-407 | Orphan drug exclusivity | July 14, 2029 | 202570 |
Xalkori NDC codes
Questions
Is there a generic for Xalkori?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xalkori (crizotinib). The Orange Book shows its last listed patent expires November 6, 2029 and its last listed exclusivity ends July 14, 2029.
What is the generic name for Xalkori?
The active ingredient in Xalkori is crizotinib, per the FDA Orange Book.
When does the Xalkori patent expire?
The last patent listed for Xalkori in the Orange Book expires November 6, 2029. 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.