FDA Orange Book
Is there a generic for Ztalmy?
Ztalmy contains ganaxolone. 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 Ztalmy (ganaxolone). The Orange Book shows its last listed patent expires September 30, 2042 and its last listed exclusivity ends June 1, 2029.
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Ztalmy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 50MG/ML | Marketed (Rx) | None | 0 | None |
NDA 215904, held by IMMEDICA PHARMA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ztalmy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8618087 | November 28, 2026 | Method of use | U-3374 | 215904 |
| 9056116 | November 28, 2026 | Method of use | U-3374 | 215904 |
| 7858609 | November 28, 2026 | Drug product | None | 215904 |
| 8022054 | November 28, 2026 | Drug product | None | 215904 |
| 8367651 | November 28, 2026 | Drug product | None | 215904 |
| 9029355 | November 28, 2026 | Drug product | None | 215904 |
| 8318714 | November 28, 2031 | Drug product | None | 215904 |
| 12144801 | August 10, 2037 | Method of use | U-4034 | 215904 |
| 10603308 | August 10, 2037 | Method of use | U-3374 | 215904 |
| 12115169 | September 30, 2042 | Method of use | U-3374 | 215904 |
| 12268696 | September 30, 2042 | Method of use | U-3374 | 215904 |
Ztalmy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 1, 2027 | 215904 |
| D-197 | New dosing schedule | October 16, 2028 | 215904 |
| ODE-395 | Orphan drug exclusivity | June 1, 2029 | 215904 |
Ztalmy NDC codes
Questions
Is there a generic for Ztalmy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ztalmy (ganaxolone). The Orange Book shows its last listed patent expires September 30, 2042 and its last listed exclusivity ends June 1, 2029.
What is the generic name for Ztalmy?
The active ingredient in Ztalmy is ganaxolone, per the FDA Orange Book.
When does the Ztalmy patent expire?
The last patent listed for Ztalmy in the Orange Book expires September 30, 2042. 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.