FDA Orange Book
Is there a generic for Vykat XR?
Vykat XR contains diazoxide choline. 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 Vykat XR (diazoxide choline). The Orange Book shows its last listed patent expires November 12, 2035 and its last listed exclusivity ends March 26, 2032.
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Vykat XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 150MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 25MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 75MG | Marketed (Rx) | None | 0 | None |
NDA 216665, held by SOLENO THERAPEUTICS - A NEUROCRINE BIOSCIENCES CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vykat XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7572789 | December 20, 2026 | Drug substance, Drug product | None | 216665 |
| 7799777 | March 5, 2029 | Drug substance | None | 216665 |
| 12343348 | November 12, 2035 | Method of use | U-4211 | 216665 |
| 12178823 | November 12, 2035 | Method of use | U-4167 | 216665 |
| 9757384 | November 12, 2035 | Method of use | U-4167 | 216665 |
| 12419895 | November 12, 2035 | Method of use | U-4275 | 216665 |
Vykat XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | March 26, 2028 | 216665 |
| ODE-532 | Orphan drug exclusivity | March 26, 2032 | 216665 |
Vykat XR NDC codes
Questions
Is there a generic for Vykat XR?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vykat XR (diazoxide choline). The Orange Book shows its last listed patent expires November 12, 2035 and its last listed exclusivity ends March 26, 2032.
What is the generic name for Vykat XR?
The active ingredient in Vykat XR is diazoxide choline, per the FDA Orange Book.
When does the Vykat XR patent expire?
The last patent listed for Vykat XR in the Orange Book expires November 12, 2035. 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.