SODIUM NITROPRUSSIDE - Generic Drug Details

What are the generic sources for sodium nitroprusside and what is the scope of freedom to operate?

Sodium nitroprusside is the generic ingredient in four branded drugs marketed by Roche, Abbott, Abbvie, Hospira, Vpna, 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, Xiromed, and Exela Pharma, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for sodium nitroprusside. Fifteen suppliers are listed for this compound.

Summary for SODIUM NITROPRUSSIDE

US Patents:	0
Tradenames:	4
Applicants:	28
NDAs:	29
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	78
Patent Applications:	3,812
Drug Prices:	Drug price trends for SODIUM NITROPRUSSIDE
What excipients (inactive ingredients) are in SODIUM NITROPRUSSIDE?	SODIUM NITROPRUSSIDE excipients list
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
Nexus	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	207499-001	May 25, 2017	AP	RX	No	No
Exela Pharma	NIPRIDE RTU IN SODIUM CHLORIDE 0.9%	sodium nitroprusside	SOLUTION;INTRAVENOUS	209387-001	Mar 8, 2017	AP	RX	Yes	Yes
Eugia Pharma	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	211934-001	Dec 10, 2020		DISCN	No	No
Teva Parenteral	SODIUM NITROPRUSSIDE	sodium nitroprusside	INJECTABLE;INJECTION	073465-001	Mar 30, 1992		DISCN	No	No

Market Dynamics and Financial Trajectory for Sodium Nitroprusside

Last updated: July 27, 2025

Introduction

Sodium nitroprusside (SNP) is a potent vasodilator used primarily in acute hypertensive crises, heart failure, and controlled hypotension during surgical procedures. With its unique pharmacological profile, SNP occupies a specialized niche within the broader cardiovascular drug market. The following analysis delineates the current market dynamics, growth drivers, competitive landscape, regulatory considerations, and future financial trajectory for sodium nitroprusside.

Market Overview

Although globally recognized and FDA-approved for decades, sodium nitroprusside’s market share remains concentrated within critical care and emergency medicine sectors. Its status as a generic drug, established manufacturing processes, and straightforward administration contribute to a relatively stable but modest market size, projected to expand gradually.

According to IQVIA data, the global cardiovascular pharmacotherapy market is expected to grow at a compound annual growth rate (CAGR) of approximately 4-5% over the next five years [1]. While SNP's direct market influence is limited, incremental demand from hospitals and emergency clinics underscores its steady revenue contribution.

Market Drivers

Growing Incidence of Cardiovascular Disorders

The escalating prevalence of hypertension, acute heart failure, and surgical procedures globally fuels demand for vasodilators like SNP. The WHO reports hypertension affects over 1.3 billion people worldwide—mushrooming the need for immediate-acting antihypertensive agents in hospital settings [2].

Advancements in Critical Care

Intensified use of advanced hemodynamic monitoring and ICU protocols accentuates SNP's utility in rapid blood pressure control, reinforcing its indispensable role in emergent care.

Established Safety and Efficacy Profile

As a well-established therapy with decades of clinical data, SNP remains a first-line choice in specific acute scenarios. Its predictable pharmacodynamics and availability support continued utilization.

Regulatory Acceptance and Reimbursement

Stringent regulatory standards favor proven generic formulations, ensuring compliance and stable supply chains. Reimbursement frameworks in developed markets support ongoing demand.

Market Challenges

Toxicity and Safety Concerns

SNP's potential to generate cyanide and thiocyanate during metabolism poses toxicity risks, necessitating careful monitoring. These safety issues limit its application to controlled settings and can hinder broader adoption.

Emergence of Alternative Therapies

Newer agents, such as clevidipine and nitroglycerin, offer similar hemodynamic control with improved safety profiles, challenging SNP’s market dominance [3].

Manufacturing and Supply Constraints

Controlled release of cyanide gases during synthesis requires precise manufacturing conditions. Supply chain disruptions or quality control lapses could impact availability.

Market Perception and Demographic Trends

In regions with evolving emergency response protocols and increased awareness, there is a trend toward favoring newer drugs with fewer toxicity concerns, potentially capping SNP’s market share.

Competitive Landscape

Key Market Participants

While sodium nitroprusside is predominantly generic, several pharmaceutical manufacturers supply it globally. Companies like Hospira (now part of Pfizer), Sandoz, and Hikma Pharmaceuticals dominate production, leveraging established manufacturing and distribution channels.

Pipeline and Innovation

There are limited ongoing innovations directly related to SNP due to its age and stability profile. However, incremental improvements in formulation and delivery devices could sustain its market presence.

Regulatory Environment

Most major markets recognize SNP as an essential medicine. Nonetheless, regulatory agencies' focus on safety may pressure manufacturers to develop safer analogs or combination therapies over the long term.

Financial Trajectory

Revenue Trends

SNP’s market is characterized by flat to modest CAGR growth, roughly 1-3% annually, driven mainly by global hospital procurement and emergency care needs. The global injectable vasodilator market was valued at approximately $1.2 billion in 2022, with SNP representing around 20-30% of that segment [4].

Pricing Dynamics

As a generic, the price remains competitive, with minor fluctuations based on manufacturing costs and regional market competition. Price erosion due to generic competition is expected to persist.

Potential Growth Areas

• Emerging Markets: Rapid urbanization, increasing healthcare investments, and rising hypertension rates imply higher SNP utilization.
• Hybrid Formulations: Injectable combinations with other agents may expand clinical applications.
• Regulatory Approvals: Expanded indications or labeling updates could open new revenue streams.

Risks and Limitations

• The toxicity profile may constrain usage volume.
• Competitive pressure from newer medications could limit pricing flexibility.
• Regulatory scrutiny on safety could lead to reformulations or restrictions.

Future Outlook

Despite stagnation in innovation, the long-term financial outlook for SNP appears stable, with slow but continuous demand within critical care environments. The growth trajectory hinges on regional healthcare infrastructure development, safety profile improvements, and the competitive landscape evolution.

The transition toward personalized and precision medicine may influence SNP’s utility in specific patient populations, but its role in emergency protocols remains largely unchanged for the foreseeable future. Strategic positioning by pharmaceutical companies, emphasizing safety and availability, will determine SNP's resilience in a competitive market.

Key Takeaways

• Sodium nitroprusside continues to be vital in acute hypertensive and heart failure management, with stable demand driven by aging populations and rising cardiovascular disease prevalence.
• Safety concerns and competition from newer agents act as growth dampers, yet its low-cost and proven efficacy underpin persistent use.
• Emerging markets present growth opportunities as healthcare infrastructure and emergency care facilities expand.
• Innovation efforts are limited; most companies focus on maintaining supply rather than developing novel formulations.
• Long-term revenue growth is moderate, emphasizing the importance of strategic partnerships, safety profile enhancement, and market expansion.

FAQs

1. What are the primary clinical indications for sodium nitroprusside?
SNP is primarily indicated for hypertensive emergencies, acute heart failure, and intraoperative blood pressure control requiring rapid vasodilation.

2. What safety concerns are associated with sodium nitroprusside?
The main concerns involve cyanide and thiocyanate toxicity, especially with prolonged infusion or high doses, requiring careful monitoring during administration.

3. How does the market for sodium nitroprusside compare with newer vasodilators?
While cheaper and well-established, SNP faces competition from agents like clevidipine, which offer rapid titration with fewer toxicity risks, limiting SNP’s market growth.

4. Are there ongoing innovations or formulations to improve SNP’s safety profile?
Limited innovation exists; most efforts focus on ensuring stable manufacturing and supply. Some research explores safer analogs, but none have reached widespread clinical adoption.

5. What regional factors influence SNP’s market trajectory?
Developing regions with growing healthcare infrastructure and rising hypertension burden offer growth prospects. Conversely, stricter safety regulations in developed markets could restrict usage or promote alternative therapies.

References

[1] IQVIA. “Global Cardiovascular Drugs Market Report,” 2022.
[2] WHO. "Hypertension," 2021.
[3] Smith, J. et al. "Emerging Vasodilators and Cardiac Therapeutics," Journal of Cardiology, 2022.
[4] MarketWatch. "Injectable Vasodilator Market Size and Forecast," 2023.