FDA Orange Book
Is there a generic for Rezurock?
Rezurock contains belumosudil. 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 Rezurock (belumosudil). The Orange Book shows its last listed patent expires July 14, 2042 and its last listed exclusivity ends July 16, 2028.
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Rezurock products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 214783, held by KADMON PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rezurock patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10183931 | October 7, 2033 | Method of use | U-4260 | 214783 |
| 10696660 | October 7, 2033 | Method of use | U-4260 | 214783 |
| 10696660 | October 7, 2033 | Method of use | U-3246 | 214783 |
| 10183931 | October 7, 2033 | Method of use | U-3246 | 214783 |
| 8357693 | June 20, 2034 | Drug substance, Drug product | U-4259 | 214783 |
| 11311541 | April 9, 2035 | Method of use | U-3369 | 214783 |
| 12097202 | July 14, 2042 | Method of use | U-4014 | 214783 |
Rezurock exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 16, 2026 | 214783 |
| ODE-362 | Orphan drug exclusivity | July 16, 2028 | 214783 |
Rezurock NDC codes
Questions
Is there a generic for Rezurock?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rezurock (belumosudil). The Orange Book shows its last listed patent expires July 14, 2042 and its last listed exclusivity ends July 16, 2028.
What is the generic name for Rezurock?
The active ingredient in Rezurock is belumosudil, per the FDA Orange Book.
When does the Rezurock patent expire?
The last patent listed for Rezurock in the Orange Book expires July 14, 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.