FDA Orange Book
Is there a generic for Duvyzat?
Duvyzat contains givinostat. 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 Duvyzat (givinostat). The Orange Book shows its last listed patent expires May 3, 2040 and its last listed exclusivity ends March 21, 2031.
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Duvyzat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | EQ 8.86MG BASE/ML | Marketed (Rx) | None | 0 | None |
NDA 217865, held by ITALFARMACO SPA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Duvyzat patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7329689 | January 15, 2027 | Drug substance, Drug product | None | 217865 |
| 9421184 | February 3, 2032 | Method of use | U-3885 | 217865 |
| 9867799 | February 3, 2032 | Method of use | U-3885 | 217865 |
| 10688047 | October 28, 2036 | Drug product | U-3885 | 217865 |
| 12606519 | May 3, 2040 | Drug substance, Drug product | None | 217865 |
Duvyzat exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 21, 2029 | 217865 |
| ODE-473 | Orphan drug exclusivity | March 21, 2031 | 217865 |
Duvyzat NDC codes
Questions
Is there a generic for Duvyzat?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Duvyzat (givinostat). The Orange Book shows its last listed patent expires May 3, 2040 and its last listed exclusivity ends March 21, 2031.
What is the generic name for Duvyzat?
The active ingredient in Duvyzat is givinostat, per the FDA Orange Book.
When does the Duvyzat patent expire?
The last patent listed for Duvyzat in the Orange Book expires May 3, 2040. 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.