FDA Orange Book
Is there a generic for Rasonque?
Rasonque contains daraxonrasib. 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 Rasonque (daraxonrasib). The Orange Book shows its last listed patent expires January 24, 2042 and its last listed exclusivity ends August 26, 2031.
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Rasonque 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 | 150MG | Marketed (Rx) | None | 0 | None |
NDA 220910, held by REVOLUTION MEDICINES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rasonque patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12403196 | September 15, 2041 | Drug substance, Drug product | None | 220910 |
| 12280113 | January 24, 2042 | Drug substance, Drug product | None | 220910 |
Rasonque exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 26, 2031 | 220910 |
Rasonque NDC codes
Questions
Is there a generic for Rasonque?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rasonque (daraxonrasib). The Orange Book shows its last listed patent expires January 24, 2042 and its last listed exclusivity ends August 26, 2031.
What is the generic name for Rasonque?
The active ingredient in Rasonque is daraxonrasib, per the FDA Orange Book.
When does the Rasonque patent expire?
The last patent listed for Rasonque in the Orange Book expires January 24, 2042. 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.