FDA Orange Book
Is there a generic for Omcazio?
Omcazio contains cabozantinib laurylsulfate. 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 Omcazio (cabozantinib laurylsulfate). The Orange Book shows its last listed patent expires January 30, 2044.
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Omcazio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 11.5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 23MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 34.5MG BASE | Marketed (Rx) | None | 0 | None |
NDA 220613, held by HANDA ONCOLOGY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Omcazio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12064430 | June 13, 2039 | Method of use | U-1480 | 220613 |
| 12064430 | June 13, 2039 | Method of use | U-2488 | 220613 |
| 12552749 | January 30, 2044 | Method of use | U-2488 | 220613 |
| 12552749 | January 30, 2044 | Method of use | U-4131 | 220613 |
| 12552749 | January 30, 2044 | Method of use | U-1480 | 220613 |
| 12552567 | January 30, 2044 | Method of use | U-1480 | 220613 |
| 12552567 | January 30, 2044 | Method of use | U-2488 | 220613 |
| 12552567 | January 30, 2044 | Method of use | U-4131 | 220613 |
| 12516025 | January 30, 2044 | Method of use | U-1480 | 220613 |
| 12516025 | January 30, 2044 | Method of use | U-2488 | 220613 |
| 12516025 | January 30, 2044 | Method of use | U-4131 | 220613 |
| 12741938 | January 30, 2044 | Drug product | None | 220613 |
| 12415784 | January 30, 2044 | Method of use | None | 220613 |
Questions
Is there a generic for Omcazio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Omcazio (cabozantinib laurylsulfate). The Orange Book shows its last listed patent expires January 30, 2044.
What is the generic name for Omcazio?
The active ingredient in Omcazio is cabozantinib laurylsulfate, per the FDA Orange Book.
When does the Omcazio patent expire?
The last patent listed for Omcazio in the Orange Book expires January 30, 2044. 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.