Viewing data from:

VYKAT XR

NDA

DIAZOXIDE CHOLINE | N216665 | SOLENO THERAPEUTICS INC

3 strengths6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (5)TodayExclusivityIPRPTAB Challenge

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

Today

Dec. 20, 2026

Mar. 5, 2029

Nov. 12, 2035

Nov. 12, 2035

Nov. 12, 2035

Nov. 12, 2035PGR

Mar. 26, 2028

ODE-532

May. 26, 2032

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2026-00034	12419895	PGR	APOTEX INC. et al.	Pending	2026-04-21	—

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Scorpion Capital LLC FDA-2025-P-3314 · 2 docket documents Scorpion Capital LLC filed this citizen petition on August 21, 2025, pursuant to 21 C.F.R. §10.20 and §10.30, requesting that the FDA issue a regulation and request a voluntary recall of VYKAT XR (diazoxide choline), which was approved on March 26, 2025, for treating hyperphagia in adults and pediat	Other	2025-08-22	Open	Scorpion Capital LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

7 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Diazoxide Choline in Hypertriglyceridemia NCT00696475	Phase 2	Completed	Essentialis, Inc.	80	2008-06 → 2009-03
Pharmacokinetic Study of Diazoxide Choline in Hypertriglyeridemic Subjects NCT01211860	Phase 1	Completed	Essentialis, Inc.	9	2010-10 → 2010-11
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia NCT01211847	Phase 2	Completed	Essentialis, Inc.	44	2010-10 → 2011-12
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome NCT02034071	Phase 1/2	Completed	Essentialis, Inc.	13	2014-04 → 2015-05
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations NCT00688857	Phase 1	Completed	Essentialis, Inc.	12	2008-05 → 2008-07
A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)NCT02893618	Phase 2	UNKNOWN	Essentialis, Inc.	32	2017-07 → 2017-12
Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline NCT00901823	Phase 1	Withdrawn	Essentialis, Inc.	—	2011-03 → 2011-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$3306.57

Highest Price

$19839.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
83860-0075-01VYKAT XR 75MG 24HR TAB,SA	$9919.72	FSS	Soleno Therapeutics, Inc.	07/31/2030
83860-0025-01VYKAT XR 25MG 24HR TAB,SA	$3306.57	FSS	Soleno Therapeutics, Inc.	07/31/2030
83860-0150-01VYKAT XR 150MG 24HR TAB,SA	$19839.44	FSS	Soleno Therapeutics, Inc.	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LABORATORIES PRIVATE LTDDIAZOXIDE CHOLINE

DMF 415342025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 28, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLD

6 patents2 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 26, 2025

Patents (6) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7572789	Dec 20, 2026	—	Yes	Yes	—	—
7799777	Mar 5, 2029	—	Yes	—	—	—
9757384	Nov 12, 2035	—	—	—		—
12178823	Nov 12, 2035	—	—	—		—
12343348	Nov 12, 2035	—	—	—		—
12419895	Nov 12, 2035	—	—	—		—

Exclusivities (2)

Code	Date	Status
NP	Mar 26, 2028	Active
ODE-532	May 26, 2032	Active

#002 — 75MG

RLD

6 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 26, 2025

#003 — 150MG

RLD

6 patents2 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 26, 2025