FDA Orange Book
Is there a generic for Wayrilz?
Wayrilz contains rilzabrutinib. 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 Wayrilz (rilzabrutinib). The Orange Book shows its last listed patent expires February 20, 2041 and its last listed exclusivity ends August 29, 2032.
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Wayrilz products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 400MG | Marketed (Rx) | None | 0 | None |
NDA 219685, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Wayrilz patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9580427 | March 1, 2033 | Drug substance, Drug product | None | 219685 |
| 9994576 | September 6, 2033 | Drug substance, Drug product | U-4268 | 219685 |
| 9994576 | September 6, 2033 | Drug substance, Drug product | U-4269 | 219685 |
| 9266895 | September 6, 2033 | Drug substance, Drug product | U-4268 | 219685 |
| 8940744 | September 6, 2033 | Drug substance, Drug product | U-4270 | 219685 |
| 12178818 | October 13, 2040 | Method of use | U-4267 | 219685 |
| 11708370 | February 20, 2041 | Drug substance | None | 219685 |
Wayrilz exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 29, 2030 | 219685 |
| ODE-552 | Orphan drug exclusivity | August 29, 2032 | 219685 |
Wayrilz NDC codes
Questions
Is there a generic for Wayrilz?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Wayrilz (rilzabrutinib). The Orange Book shows its last listed patent expires February 20, 2041 and its last listed exclusivity ends August 29, 2032.
What is the generic name for Wayrilz?
The active ingredient in Wayrilz is rilzabrutinib, per the FDA Orange Book.
When does the Wayrilz patent expire?
The last patent listed for Wayrilz in the Orange Book expires February 20, 2041. 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.