FDA Orange Book
Is there a generic for Stivarga?
Stivarga contains regorafenib. 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 Stivarga (regorafenib). The Orange Book shows its last listed patent expires July 9, 2032.
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Stivarga products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 203085, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Stivarga patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8680124 | June 2, 2030 | Method of use | U-1506 | 203085 |
| 8637553 | February 16, 2031 | Drug substance, Drug product | None | 203085 |
| 9458107 | April 8, 2031 | Drug product | None | 203085 |
| 9957232 | July 9, 2032 | Drug substance | None | 203085 |
Stivarga NDC codes
Questions
Is there a generic for Stivarga?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Stivarga (regorafenib). The Orange Book shows its last listed patent expires July 9, 2032.
What is the generic name for Stivarga?
The active ingredient in Stivarga is regorafenib, per the FDA Orange Book.
When does the Stivarga patent expire?
The last patent listed for Stivarga in the Orange Book expires July 9, 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.