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HYPERSTAT

NDA

DIAZOXIDE | N016996 | SCHERING CORP SUB SCHERING PLOUGH CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

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

2 petitions (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
Citizen Petition from LyphoMed, Inc. FDA-1987-P-0374 · 5 docket documents LyphoMed, Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the Commissioner of Food and Drugs declare Diazoxide Injection USP 15 mg/mL (150 mg/10 mL) in a single-dose syringe suitable for evaluation as an abbreviated new drug application.	Other	2017-07-26	Granted	LyphoMed, Inc.

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

Clinical Trials

22 trials from ClinicalTrials.gov — 1 recruiting, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Regulation of Endogenous Glucose Production by Central KATP Channels NCT03540758	Phase 2	Recruiting	Albert Einstein College of Medicine	100	2018-08-01 → 2027-04
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia NCT01211847	Phase 2	Completed	Essentialis, Inc.	44	2010-10 → 2011-12
Hypothalamic Obesity Following Craniopharyngioma Surgery: A Pilot Trial of Combined Metformin and Diazoxide Therapy NCT00892073	Phase 2	Completed	The Hospital for Sick Children	9	2006-05 → 2008-01
Use of Diazoxide in Acute Hypoglycaemia NCT01488136	Phase 4	Completed	University of Dundee	12	2012-01 → 2013-03
Efficacy of Diazoxide in Type 1 Diabetes NCT00131755	Phase 4	Completed	Grill, Valdemar, M.D.	40	2005-02 → 2008-08
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
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men NCT00151684	Phase 2	Completed	Rijnstate Hospital	25	2004-11
DZX Mediated Insulin Suppression in Obese Men NCT00631033	Phase 2	Completed	Rijnstate Hospital	51	2008-07 → 2011-12
Effect of Diazoxide on the Obesity Secondary to Hypothalamic-pituitary Lesions NCT00306683	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris	40	2006-04 → 2009-04
Diazoxide Choline in Hypertriglyceridemia NCT00696475	Phase 2	Completed	Essentialis, Inc.	80	2008-06 → 2009-03

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

API Supply Chain6 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

LUNDBECK PHARMACEUTICALS ITALY SPADIAZOXIDE

DMF 70311987

NOVITIUM PHARMA LLCDIAZOXIDE USP

DMF 312492017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDIAZOXIDE

DMF 323352017

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDDIAZOXIDE USP

DMF 327712018

MSN LABORATORIES PRIVATE LTDDIAZOXIDE USP

DMF 353512020

SUZHOU YIFAN PHARMACEUTICAL CO LTDDIAZOXIDE

DMF 428902025

TRANSO PHARM PRODUKTIONS GMBHInactiveDIAZOXIDE

DMF 168192003

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

Products (1)

#001 — 15MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.