FDA Orange Book
Is there a generic for Odomzo?
Odomzo contains sonidegib. 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 Odomzo (sonidegib). The Orange Book shows its last listed patent expires March 30, 2036.
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Odomzo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 205266, held by SUN PHARMACEUTICAL INDUSTRIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Odomzo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8178563 | July 24, 2029 | Drug substance | U-1722 | 205266 |
| 8063043 | September 15, 2029 | Drug substance, Drug product | None | 205266 |
| 10266523 | March 30, 2036 | Drug substance, Drug product | None | 205266 |
Odomzo NDC codes
Questions
Is there a generic for Odomzo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Odomzo (sonidegib). The Orange Book shows its last listed patent expires March 30, 2036.
What is the generic name for Odomzo?
The active ingredient in Odomzo is sonidegib, per the FDA Orange Book.
When does the Odomzo patent expire?
The last patent listed for Odomzo in the Orange Book expires March 30, 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.