FDA Orange Book
Is there a generic for Mayzent?
Mayzent contains siponimod. 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 Mayzent (siponimod). The Orange Book shows its last listed patent expires April 23, 2036.
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Mayzent products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 0.25MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 2MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209884, 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.
Mayzent patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7939519 | August 27, 2028 | Drug substance, Drug product | None | 209884 |
| 8492441 | November 30, 2030 | Method of use | U-2511 | 209884 |
| 12071402 | January 5, 2032 | Drug product | None | 209884 |
| 12533340 | April 23, 2036 | Method of use | U-4407 | 209884 |
| 11944602 | April 23, 2036 | Method of use | U-3889 | 209884 |
Mayzent NDC codes
Questions
Is there a generic for Mayzent?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Mayzent (siponimod). The Orange Book shows its last listed patent expires April 23, 2036.
What is the generic name for Mayzent?
The active ingredient in Mayzent is siponimod, per the FDA Orange Book.
When does the Mayzent patent expire?
The last patent listed for Mayzent in the Orange Book expires April 23, 2036. 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.