FDA Orange Book
Is there a generic for Daurismo?
Daurismo contains glasdegib. 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 Daurismo (glasdegib). The Orange Book shows its last listed patent expires April 13, 2036.
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Daurismo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210656, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Daurismo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8431597 | June 29, 2028 | Drug product | None | 210656 |
| 8148401 | November 21, 2032 | Drug substance, Drug product | None | 210656 |
| 11168066 | April 13, 2036 | Method of use | U-3254 | 210656 |
| 11891372 | April 13, 2036 | Method of use | U-3254 | 210656 |
| 10414748 | April 13, 2036 | Drug substance, Drug product | None | 210656 |
Daurismo NDC codes
Questions
Is there a generic for Daurismo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Daurismo (glasdegib). The Orange Book shows its last listed patent expires April 13, 2036.
What is the generic name for Daurismo?
The active ingredient in Daurismo is glasdegib, per the FDA Orange Book.
When does the Daurismo patent expire?
The last patent listed for Daurismo in the Orange Book expires April 13, 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.