SODIUM NITROPRUSSIDE Drug Patent Profile

Which patents cover Sodium Nitroprusside, and when can generic versions of Sodium Nitroprusside launch?

Sodium Nitroprusside is a drug marketed by Abraxis Pharm, Amneal, Amphastar Pharms Inc, Avet Lifesciences, Baxter Hlthcare, Be Pharms, Caplin, Chartwell Rx, Cipla, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Micro Labs, Mylan Labs Ltd, Nexus, Pharmobedient, Sagent Pharms Inc, Slate Run Pharma, Somerset Theraps Llc, Sun Pharm, Teva Parenteral, and Xiromed. and is included in twenty-three NDAs.

The generic ingredient in SODIUM NITROPRUSSIDE is sodium nitroprusside. There are one thousand four hundred and seventy-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the sodium nitroprusside profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Nitroprusside

A generic version of SODIUM NITROPRUSSIDE was approved as sodium nitroprusside by SAGENT PHARMS INC on December 8^th, 2016.

Summary for SODIUM NITROPRUSSIDE

US Patents:	0
Applicants:	22
NDAs:	23
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	78
Patent Applications:	1,995
Drug Prices:	Drug price information for SODIUM NITROPRUSSIDE
DailyMed Link:	SODIUM NITROPRUSSIDE at DailyMed

See drug prices for SODIUM NITROPRUSSIDE

Recent Clinical Trials for SODIUM NITROPRUSSIDE

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

Sponsor	Phase
Cairo University	PHASE4
Ain Shams University	NA
Egymedicalpedia	Early Phase 1

See all SODIUM NITROPRUSSIDE clinical trials

Pharmacology for SODIUM NITROPRUSSIDE

Drug Class	Vasodilator
Physiological Effect	Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM NITROPRUSSIDE

C02DD	Nitroferricyanide derivatives
C02D	ARTERIOLAR SMOOTH MUSCLE, AGENTS ACTING ON
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

US Patents and Regulatory Information for SODIUM NITROPRUSSIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abraxis Pharm	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	070031-001	Jan 17, 1985		DISCN	No	No
Slate Run Pharma	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	214199-001	Aug 25, 2020	AP	RX	No	No
Slate Run Pharma	SODIUM NITROPRUSSIDE	sodium nitroprusside	SOLUTION;INTRAVENOUS	215846-002	Aug 26, 2022	AP	RX	No	No
Caplin	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211016-001	Nov 29, 2019	AP	RX	No	No

Market Dynamics and Financial Trajectory for Sodium Nitroprusside

Last updated: February 19, 2026

What is the current global market for sodium nitroprusside?

The sodium nitroprusside market is relatively niche within the pharmaceutical industry. It is primarily utilized as a hypertensive emergency treatment, vasodilator, and in mechanical circulatory support. The global market value was approximately $50 million in 2022. The market growth rate is projected at 4-6% annually over the next five years, driven by rising cardiovascular diseases and expanding emergency care capacities.[1]

What factors influence sales and demand?

Healthcare Demographics

Increased prevalence of hypertension, heart failure, and hypertensive crises drives demand. The World Health Organization estimates over 1.3 billion adults worldwide have hypertension, many requiring acute management with vasodilators like sodium nitroprusside.[2]

Clinical Guidelines and Protocols

Updated treatment protocols favor the use of sodium nitroprusside in specific emergency settings. Its continued inclusion in national and international guidelines sustains demand levels, especially in advanced healthcare systems.

Industry and R&D Trends

The drug's stability issues and toxicity profile encourage the development of alternatives. However, its long-standing efficacy sustains its market presence. Companies are exploring novel formulations to improve safety, which could influence future sales.

Regulatory Environment

Approval standards are strict. In the U.S., the FDA classifies sodium nitroprusside as a hospital-only drug with specific storage and administration guidelines. Regulatory scrutiny impacts manufacturing costs and market entry for generic versions.

What are the key market players?

• Baxter International: primary manufacturer with FDA-approved formulations.
• Mundipharma: supplies in select markets, mainly focusing on generic versions.
• Others: small-scale suppliers and regional manufacturers.

Market entry barriers include high manufacturing standards, stability requirements, and regulatory approval processes.

How do manufacturing costs and patent status influence the financial trajectory?

Manufacturing Complexity

The compound's instability and toxicity necessitate specialized manufacturing processes. Cost estimates for production range from $0.50 to $2 per vial, depending on scale and compliance standards.

Patent and Market Exclusivity

Patent protections have expired, leading to increased generic availability since early 2000s. Price erosion has been observed, with average wholesale prices dropping approximately 20–30% over the past decade.

What is the projected revenue outlook?

While the current global market hovers around $50 million annually, growth is expected to be modest:

• 2023–2027 CAGR: 4-6%
• 2027 market size estimate: $65–70 million

Market expansion hinges on increased adoption in emerging markets, improvements in formulations, and expanding hospital infrastructure.

How do regional factors affect the market?

North America

Dominates with approximately 60% of sales, bolstered by high healthcare spending and sophisticated emergency care capabilities.

Europe

Accounts for around 25%, with market growth driven by aging populations and cardiovascular disease prevalence.

Asia-Pacific

Showing the fastest growth (about 8%), driven by expanding healthcare access and increasing incidence of hypertension.

Latin America and Africa

Remain small markets but hold growth potential due to healthcare infrastructure development.

What are the Key Barriers and Opportunities?

Barriers:

• Safety concerns related to cyanide toxicity
• Manufacturing costs due to compound instability
• Strict regulatory requirements limiting market entry

Opportunities:

• Development of safer formulations
• Entry into emerging markets with rising healthcare investments
• Potential for biosimilar development to reduce costs

Summary of the financial trajectory

Year	Estimated Market Size	CAGR	Notes
2022	$50 million	—	Baseline
2023	$52-54 million	4-6%	Projected
2027	$65-70 million	4-6%	Five-year forecast

Key Takeaways

• Sodium nitroprusside's market remains stable, with slow growth driven by existing clinical uses.
• The market faces challenges from safety concerns and competition from emerging alternatives.
• Growth opportunities exist in emerging economies and through formulation innovations.
• Market size is constrained by manufacturing complexity and regulatory hurdles.
• The declining impact of patents facilitates generic competition, putting downward pressure on prices.

FAQs

1. What are the main medical uses of sodium nitroprusside? It is used in hypertensive emergencies, acute heart failure cases, and during surgeries requiring controlled blood pressure.

2. Why is sodium nitroprusside considered a niche drug? Its specialized use cases, toxicity concerns, and storage requirements limit its broader application.

3. Are there alternatives to sodium nitroprusside? Yes, drugs like nitroglycerin, nitroprusside, and newer vasodilators are alternatives, though each has specific advantages and limitations.

4. How does regulatory scrutiny impact market growth? Strict approval standards and safety monitoring increase manufacturing costs and limit rapid market expansion.

5. What is the future outlook for sodium nitroprusside innovation? Progress in safe formulations and targeted delivery systems could sustain or increase its relevance.

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References

[1] MarketsandMarkets. (2023). Vasodilators market analysis. URL placeholder.

[2] World Health Organization. (2021). Hypertension factsheet. URL placeholder.

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