FDA Orange Book
Is there a generic for Rhapsido?
Rhapsido contains remibrutinib. 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 Rhapsido (remibrutinib). The Orange Book shows its last listed patent expires January 19, 2043 and its last listed exclusivity ends September 30, 2030.
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Rhapsido products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Marketed (Rx) | None | 0 | None |
NDA 218436, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rhapsido patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10457647 | November 13, 2034 | Method of use | U-4280 | 218436 |
| 9512084 | November 13, 2034 | Drug substance, Drug product | None | 218436 |
| 12419889 | January 19, 2043 | Method of use | U-4281 | 218436 |
Rhapsido exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 30, 2030 | 218436 |
Rhapsido NDC codes
Questions
Is there a generic for Rhapsido?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rhapsido (remibrutinib). The Orange Book shows its last listed patent expires January 19, 2043 and its last listed exclusivity ends September 30, 2030.
What is the generic name for Rhapsido?
The active ingredient in Rhapsido is remibrutinib, per the FDA Orange Book.
When does the Rhapsido patent expire?
The last patent listed for Rhapsido in the Orange Book expires January 19, 2043. 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.