FDA Orange Book
Is there a generic for Caprelsa?
Caprelsa contains vandetanib. 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 Caprelsa (vandetanib). The Orange Book shows its last listed patent expires August 8, 2028.
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Caprelsa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 300MG | Marketed (Rx) | None | 0 | None |
NDA 022405, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Caprelsa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8067427 | August 8, 2028 | Drug product | None | 022405 |
Caprelsa NDC codes
Questions
Is there a generic for Caprelsa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Caprelsa (vandetanib). The Orange Book shows its last listed patent expires August 8, 2028.
What is the generic name for Caprelsa?
The active ingredient in Caprelsa is vandetanib, per the FDA Orange Book.
When does the Caprelsa patent expire?
The last patent listed for Caprelsa in the Orange Book expires August 8, 2028. 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.