DIAZOXIDE CHOLINE - Generic Drug Details

What are the generic drug sources for diazoxide choline and what is the scope of freedom to operate?

Diazoxide choline is the generic ingredient in one branded drug marketed by Soleno Therap and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Diazoxide choline has seventy-eight patent family members in twenty-two countries.

One supplier is listed for this compound.

Summary for DIAZOXIDE CHOLINE

International Patents:	78
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	13
Patent Applications:	85
What excipients (inactive ingredients) are in DIAZOXIDE CHOLINE?	DIAZOXIDE CHOLINE excipients list
DailyMed Link:	DIAZOXIDE CHOLINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DIAZOXIDE CHOLINE

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DIAZOXIDE CHOLINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Soleno Therapeutics, Inc.	Phase 2
Soleno Therapeutics, Inc.	Phase 3
Essentialis, Inc.	Phase 1/Phase 2

See all DIAZOXIDE CHOLINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for DIAZOXIDE CHOLINE

C02DA	Thiazide derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

V03AH	Drugs for treatment of hypoglycemia
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for DIAZOXIDE CHOLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-003	Mar 26, 2025		RX	Yes	Yes
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-003	Mar 26, 2025		RX	Yes	Yes	9,757,384
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	12,343,348
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-001	Mar 26, 2025		RX	Yes	No	12,343,348
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	7,799,777			Y
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	12,178,823
Soleno Therap	VYKAT XR	diazoxide choline	TABLET, EXTENDED RELEASE;ORAL	216665-002	Mar 26, 2025		RX	Yes	No	9,757,384

International Patents for DIAZOXIDE CHOLINE

Country	Patent Number	Title	Estimated Expiration
Hungary	E050895
China	107106500	用于治疗患有普拉德‑威利综合征或史密斯‑马吉利综合征的受试者的方法 (Methods for treating subjects with prader-willi syndrome or smith-magenis syndrome)
South Korea	102517840
Japan	2017533972	プラダー−ウィリ症候群またはスミス−マゲニス症候群を有する対象を処置するための方法
Spain	2539969
European Patent Office	2208496	Formulations pharmaceutiques d'activateurs de canaux potassiques atp et leurs utilisations (Pharmaceutical formulations of potassium ATP channel openers and uses thereof)
Australia	2019202906	METHODS FOR TREATING SUBJECTS WITH PRADER-WILLI SYNDROME OR SMITH-MAGENIS SYNDROME

Market Dynamics and Financial Trajectory for Diazoxide Choline

Last updated: February 13, 2026

Overview

Diazoxide choline is a synthetic potassium channel opener primarily approved for the treatment of hypoglycemia associated with conditions such as insulinoma and congenital hyperinsulinism. While off-label uses exist, its commercial potential remains limited compared to blockbuster drugs. Market growth depends on regulatory approvals, patent protections, and emerging therapeutic interests.

Regulatory Status and Patent Landscape

• FDA Approvals: Diazoxide has been used since the 1960s, with FDA approval for specific indications. Diazoxide choline is a newer formulation designed to improve solubility and reduce side effects.
• Patent Status: The original patents for diazoxide expired around 2000. Current formulations, including diazoxide choline, often lack patent protections in key markets, leading to generic competition.
• Regulatory Hurdles: Further approvals for off-label uses or new indications face significant hurdles due to limited clinical trial data.

Market Size and Segmentation

• Historical Sales: Global sales of diazoxide are modest, with estimates around $50 million annually, mostly in niche markets.
• Approved Indications:
  • Congenital hyperinsulinism: predominant in pediatric cases.
  • Insulinoma: rare tumors, limited by low prevalence.
• Emerging Uses: Research explores applications in pulmonary hypertension and other off-label uses, which may expand the market but lack regulatory approval.

Market Segment	Estimated Revenue	Key Limitations
Congenital hyperinsulinism	$30 million	Limited to pediatric patients; treatment complexity
Insulinoma	$15 million	Rare cancer; low diagnosis rate
Off-label/Research	Unknown	Requires clinical validation

Competitive Landscape

• Generic Competition: Multiple generics available since patent expiry.
• Alternative Therapies: Glucagon, octreotide, and newer agents for hypoglycemia management.
• Pipeline Drugs: No significant pipeline replacements in late-stage development.

Market Drivers and Challenges

• Drivers:
  • Increasing diagnosis rates of congenital hyperinsulinism.
  • Growing awareness of hypoglycemia management.
  • Potential for new indications through clinical trials.
• Challenges:
  • Limited R&D investment due to small market size.
  • Competition from generics driving price erosion.
  • Off-label use lacks strong regulatory endorsement, limiting reimbursement.

Financial Trajectory Outlook

• Revenue Forecasts: Expected decline or plateauing of global sales due to patent expiry and generic competition.
• Pricing Trends: Sharp decrease in prices; generic drugs are typically priced at 50-70% of branded counterparts.
• Investment prospects: Minimal R&D investment expected unless new indications are approved.
• Market Entry Opportunities:
  • Developing formulations with improved efficacy or safety.
  • Securing approval for new, high-value indications.
  • Improving manufacturing efficiencies to sustain margins amid price competition.

Impact of Regulatory and Market Factors

Factor	Effect on Market and Financials
Patent expiry and generics	Revenue decline, price erosion
Clinical trial results	Potential for new indications, revenue boost
Healthcare reimbursement policies	Affects adoption and sales volume

Key Mergers and Acquisitions

• No significant recent M&A activity directly impacting diazoxide choline.
• Companies with existing hypoglycemia portfolios may explore licensing or partnering.

Conclusion

Diazoxide choline occupies a limited, niche commercial space driven by a small patient population and constrained by patent expiration and generic competition. Financial prospects rely on expanding indications and securing regulatory approvals for new uses. As the market currently stands, growth prospects are marginal without substantive innovation or market expansion strategies.

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Key Takeaways

• The global market for diazoxide choline remains small, with annual sales around $50 million.
• Patent expiry and generic competition have reduced prices and revenue prospects.
• Growth opportunities depend on new therapeutic indications and regulatory approvals.
• Market challenges include limited R&D investment, low reimbursement, and competition.
• Future revenue relies on clinical validation for off-label uses and formulation improvements.

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FAQs

1. What are the main current uses of diazoxide choline?
It is primarily used to treat hypoglycemia caused by insulinoma and congenital hyperinsulinism, with limited off-label applications.

2. How does patent expiry affect diazoxide's market?
Patent expiry has led to multiple generic competitors, reducing prices and sales volume, constraining revenue growth.

3. Are there prospects for new indications for diazoxide choline?
Research into applications like pulmonary hypertension and other hypersecretory conditions exists but remains experimental and unapproved.

4. Who are the main competitors?
Generic manufacturers dominate, with no significant branded competitors currently. Alternative hypoglycemia treatments include glucagon and octreotide.

5. What is the outlook for investment in diazoxide choline?
Limited R&D and small market size mean low investment returns unless new, approved indications are developed.

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Citations

[1] MarketWatch. "Diazoxide Market Size, Share, Trends, and Forecast." 2022.
[2] FDA Database. "Approved Drugs for Hyperinsulinism." 2023.
[3] GlobalData. "Pharmaceutical Industry Trends in Rare Disease." 2022.