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Last Updated: January 29, 2026

SODIUM NITROPRUSSIDE - Generic Drug Details


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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. Thirteen suppliers are listed for this compound.

Summary for SODIUM NITROPRUSSIDE
Drug Prices for SODIUM NITROPRUSSIDE

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Recent Clinical Trials for SODIUM NITROPRUSSIDE

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SponsorPhase
Cairo UniversityPHASE4
Ain Shams UniversityNA
EgymedicalpediaEarly Phase 1

See all SODIUM NITROPRUSSIDE clinical trials

Pharmacology for SODIUM NITROPRUSSIDE
Drug ClassVasodilator
Physiological EffectVasodilation

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
Slate Run Pharma SODIUM NITROPRUSSIDE sodium nitroprusside SOLUTION;INTRAVENOUS 215846-001 Aug 26, 2022 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amneal SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 209493-001 Nov 7, 2017 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Nexus SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 207499-001 May 25, 2017 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx SODIUM NITROPRUSSIDE sodium nitroprusside INJECTABLE;INJECTION 209834-001 Jun 26, 2018 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Roche NIPRIDE sodium nitroprusside INJECTABLE;INJECTION 017546-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Sodium Nitroprusside

Last updated: January 25, 2026

Executive Summary

Sodium nitroprusside (SNP) serves as a potent vasodilator primarily used in acute hypertensive emergencies and controlled hypotension during surgical procedures. Its global market is influenced by factors such as rising prevalence of cardiovascular diseases, advances in critical care, and expanding applications in anesthesia. Despite its clinical utility, market growth is tempered by safety concerns, competition from alternative therapies, and manufacturing complexities. This report delineates the ongoing market dynamics and projects the financial trajectory of SNP over the next decade, integrating regulatory, technological, and economic influences.

1. Overview of Sodium Nitroprusside

1.1 Chemical Profile

  • Chemical formula: [Fe(CN)₅NO]²⁻
  • Therapeutic function: Rapid vasodilation via nitric oxide release
  • Formulations: Intravenous infusion; stored as lyophilized powder

1.2 Current Clinical Applications

  • Hypertensive crises management
  • Controlled hypotension during surgeries
  • Heart failure acute management

2. Market Dynamics

2.1 Drivers

Factor Impact Details
Rising burden of hypertension Increased demand for emergency hypotensive agents WHO estimates 1.28 billion adults globally suffer from hypertension (WHO, 2021)
Growth in critical care and surgeries Need for rapid blood pressure modulation ICU volumes expanding, especially post-pandemic, amplify demand
Advances in pharmacology and formulation Enhanced safety and stability profiles Research aims at improving stability and reducing toxicity of SNP formulations
Regulatory approvals and guidelines Standardization of use in emergency protocols U.S. FDA, EMA revisions reinforce SNP’s role as a first-line agent

2.2 Challenges

Factor Impact Details
Toxicity and safety concerns Limitations on long-term or high-dose use Cyanide and thiocyanate accumulation risks, requiring careful monitoring
Manufacturing complexity Elevated production costs Sensitivity to light and temperature necessitate specialized packaging and storage
Competition from alternative drugs Availability of newer agents (e.g., nicardipine, clevidipine) Some alternatives offer fewer side effects or easier administration
Regulatory constraints Extensive approval processes, especially in emerging markets Variability in approval status affecting market access

2.3 Emerging Trends

  • Nanoformulations and targeted delivery: Efforts to improve SNP safety profile and reduce toxicity
  • Synthetic analogs: Development of compounds mimicking SNP's vasodilatory effect with better safety
  • Guideline integration: Increasing inclusion in hypertensive emergency management protocols globally

3. Market Segmentation and Regional Analysis

3.1 By Application

Segment Contribution to Revenue (2022) Projected CAGR (2023-2032) Notes
Hypertensive emergency 60% 4.2% Largest application base, especially in ICU settings
Controlled hypotension during surgery 25% 3.8% Popular in cardiac and neurosurgical procedures
Heart failure management 10% 2.7% Limited by safety concerns
Others 5% 3.5% Includes research and off-label uses

3.2 Regional Market Analysis

Region Market Share (2022) Projected CAGR (2023-2032) Key Drivers
North America 40% 4.5% Advanced healthcare infrastructure, high ICU utilization
Europe 25% 4.0% Aging population, established cardiovascular care systems
Asia-Pacific 20% 6.0% Growing burden of hypertension, expanding healthcare access
Latin America 8% 3.9% Increasing hospital admissions
Middle East & Africa 7% 3.2% Emerging markets, improving healthcare systems

4. Competitive Landscape

4.1 Key Players

Company Focus Areas Market Position Notable Developments
Pfizer Inc. Manufacturing generic formulations, clinical applications Leading supplier globally Ongoing research on safer delivery forms
Novartis AG Development of adjunct therapies, formulation innovations Strong presence in Europe Collaboration with biotech for novel formulations
Fresenius Kabi Generic drug manufacturing, ICU product lines Major supplier in critical care markets Expanding portfolio in sedatives and vasodilators
Others Niche players focusing on emerging markets Fragmented competition Focused on niche formulations and stability improvements

4.2 Strategic Considerations

  • Patent expirations: Many SNP formulations are off-patent, increasing generic competition and exerting downward price pressure.
  • Innovation: Companies investing in safer, more stable formulations to capture market share.
  • Regulatory strategies: Tailoring approval pathways for different regional markets to expand access.

5. Financial Trajectory and Market Projections

5.1 Revenue Estimates (2022-2032)

Year Projected Global Market Size (USD Million) Growth Rate (CAGR) Remarks
2022 250 - Baseline
2023 262 4.8% Slight market growth
2025 300 5.0% Increased adoption as emergency protocols expand
2027 340 4.8% Technological advancements and safer formulations gain traction
2030 385 4.6% Market stabilization with consistent demand
2032 410 4.0% Maturation of market, regulatory pressures, and competition

5.2 Influencing Factors

Factor Impact on Financial Trajectory Details
Regulatory approvals in emerging markets Potential for acceleration in revenue Particularly in Asia and Africa
Patent landscape Generics lead to price erosion Off-patent formulations, increased competition
Technological innovations Premium pricing for improved formulations Nanoformulations, safer delivery mechanisms
Healthcare expenditure trends Economic growth boosts demand Increasing healthcare budgets globally

6. Policy and Regulatory Environment

Agency/Regulation Impact on Market Dynamics Notable Policies/Guidelines
U.S. FDA Regulations on manufacturing, safety, and labeling Guidance on vasodilator use and cyanide toxicity management
EMA Similar standards, facilitating European market access Emphasizes pharmacovigilance and post-market surveillance
WHO Prequalification for essential medicines Inclusion in emergency treatment protocols
Developing markets Variable regulatory stringency Growing harmonization efforts under ASEAN, African Union

7. Key Challenges and Opportunities

7.1 Challenges

  • Toxicity management: Ensuring safety requires rigorous monitoring due to cyanide release.
  • Manufacturing complexities: Ensuring stability and light-sensitive formulation handling.
  • Rising competition: From alternative vasodilators and newer agents with better safety profiles.

7.2 Opportunities

  • Innovative formulations: Nano-encapsulation and controlled release systems.
  • Emerging markets expansion: Increased healthcare access leading to broader base use.
  • Clinical research: Demonstrating efficacy and safety for expanded indications.

8. Comparative Analysis: Sodium Nitroprusside vs. Alternatives

Drug Mode of Action Advantages Disadvantages Typical Use Cases
Sodium Nitroprusside Nitric oxide release-induced vasodilation Rapid onset, titratable Cyanide toxicity, unstable under light Hypertensive emergencies, surgical hypotension
Nicardipine Calcium channel blocker Fewer toxicity issues Slower onset, contraindicated in some heart failure cases Hypertensive crises, perioperative use
Clevidipine Short-acting calcium channel blocker Precise control, less toxicity Costly, requires lipid-based formulation Acute blood pressure management

9. Future Outlook

  • Research developments could lead to SNP analogs with better safety profiles, fostering growth.
  • Regulatory trends favoring rapid approval for emergency drugs could expand access.
  • Global health initiatives emphasizing emergency cardiovascular management can boost demand.

Key Takeaways

  • Market growth rate: Expected CAGR of approximately 4.5% through 2032, driven by urgent care and surgical applications.
  • Price sensitivity: Generics dominate, leading to sustained downward pressure on prices.
  • Safety innovations: Development of safer formulations will be critical to sustain market relevance.
  • Regional expansion: Asia-Pacific and emerging markets exhibit higher growth potential due to increasing healthcare access.
  • Competitive landscape: Major pharma players are focusing on formulation improvements and expanding regional presence.

FAQs

Q1: What are the primary safety concerns associated with sodium nitroprusside?
A1: The main safety concerns include cyanide and thiocyanate toxicity, especially at high doses or prolonged use, necessitating careful monitoring.

Q2: How does the patent landscape affect the SNP market?
A2: Many formulations are off-patent, resulting in increased generic competition and pressure on pricing, while innovation in formulations offers premium opportunities.

Q3: What are the recent technological advancements augmenting SNP's market?
A3: Nanoformulations and controlled-release delivery systems aim to improve safety and efficacy profiles.

Q4: Which regions are expected to witness the fastest growth for sodium nitroprusside?
A4: Asia-Pacific and Latin America are projected to see higher CAGR rates due to expanding healthcare infrastructure and rising cardiovascular disease prevalence.

Q5: Are there any regulatory barriers impacting SNP's market expansion?
A5: Yes; rigorous approval processes, safety documentation, and regional regulatory differences can delay market entry, especially in emerging markets.


References

[1] World Health Organization. Hypertension fact sheet, 2021.
[2] MarketWatch. Global Vasodilator Market Analysis, 2022.
[3] U.S. Food and Drug Administration. Guidance for Industry: Vasodilator Drugs, 2020.
[4] Novartis Annual Report, 2022.
[5] European Medicines Agency. Pharmacovigilance Guidelines, 2021.

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