FDA Orange Book
Is there a generic for Zeposia?
Zeposia contains ozanimod. 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 Zeposia (ozanimod). The Orange Book shows its last listed patent expires September 30, 2038 and its last listed exclusivity ends August 30, 2027.
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Zeposia products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.23MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.46MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.92MG BASE | Marketed (Rx) | None | 0 | None |
NDA 209899, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zeposia patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9382217 | May 14, 2029 | Method of use | U-2774 | 209899 |
| 8796318 | May 14, 2029 | Drug substance, Drug product | None | 209899 |
| 10239846 | November 15, 2030 | Method of use | U-3740 | 209899 |
| 8481573 | March 24, 2033 | Drug substance, Drug product | U-2774 | 209899 |
| 11680050 | September 30, 2038 | Drug substance, Drug product | U-2774 | 209899 |
| 11680050 | September 30, 2038 | Drug substance, Drug product | U-3740 | 209899 |
Zeposia exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-309 | Miscellaneous | August 30, 2027 | 209899 |
Zeposia NDC codes
Questions
Is there a generic for Zeposia?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zeposia (ozanimod). The Orange Book shows its last listed patent expires September 30, 2038 and its last listed exclusivity ends August 30, 2027.
What is the generic name for Zeposia?
The active ingredient in Zeposia is ozanimod, per the FDA Orange Book.
When does the Zeposia patent expire?
The last patent listed for Zeposia in the Orange Book expires September 30, 2038. 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.