Question 1

Is there a generic for Diazoxide choline?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Diazoxide choline. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Diazoxide choline?

Accepted Answer

VYKAT XR (NDA 216665, SOLENO THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Diazoxide choline?

Accepted Answer

The Orange Book lists 6 patents against Diazoxide choline products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Diazoxide choline have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Diazoxide choline. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Diazoxide choline are approved?

Accepted Answer

Diazoxide choline is approved in the following dosage form: tablet, extended release.

Patent	Expires	In	Type
7572789	Dec 20, 2026	in 6 mo	SubstanceProduct
7799777	Mar 05, 2029	in 2 yr 9 mo	Substance
12343348	Nov 12, 2035	in 9 yr 6 mo	U-4211
12178823	Nov 12, 2035	in 9 yr 6 mo	U-4167
9757384	Nov 12, 2035	in 9 yr 6 mo	U-4167
12419895	Nov 12, 2035	in 9 yr 6 mo	U-4275

Diazoxide choline

Brand (NDA) products · tablet, extended release

Marketing exclusivity (6)

Listed patents (6)

Diazoxide choline — frequently asked questions

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