FDA Orange Book
Is there a generic for Cometriq?
Cometriq contains cabozantinib s-malate. 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 Cometriq (cabozantinib s-malate). The Orange Book shows its last listed patent expires February 10, 2032.
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Cometriq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 80MG BASE | Marketed (Rx) | None | 0 | None |
NDA 203756, held by EXELIXIS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Cometriq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7579473 | August 14, 2026 | Drug substance, Drug product | None | 203756 |
| 11098015 | January 15, 2030 | Method of use | U-1617 | 203756 |
| 11091440 | January 15, 2030 | Drug product | None | 203756 |
| 11091439 | January 15, 2030 | Drug substance | None | 203756 |
| 8877776 | October 8, 2030 | Drug substance, Drug product | U-1617 | 203756 |
| 12128039 | February 10, 2032 | Drug product | U-1617 | 203756 |
| 11298349 | February 10, 2032 | Drug product | None | 203756 |
| 9717720 | February 10, 2032 | Drug product | None | 203756 |
Cometriq NDC codes
Questions
Is there a generic for Cometriq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Cometriq (cabozantinib s-malate). The Orange Book shows its last listed patent expires February 10, 2032.
What is the generic name for Cometriq?
The active ingredient in Cometriq is cabozantinib s-malate, per the FDA Orange Book.
When does the Cometriq patent expire?
The last patent listed for Cometriq in the Orange Book expires February 10, 2032. 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.