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Last Updated: March 19, 2026

NIPRIDE Drug Patent Profile


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When do Nipride patents expire, and when can generic versions of Nipride launch?

Nipride is a drug marketed by Roche and Exela Pharma and is included in two NDAs.

The generic ingredient in NIPRIDE 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 Nipride

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

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  • What is the 5 year forecast for NIPRIDE?
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Summary for NIPRIDE
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for NIPRIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Exela Pharma NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387-001 Mar 8, 2017 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Exela Pharma NIPRIDE RTU IN SODIUM CHLORIDE 0.9% sodium nitroprusside SOLUTION;INTRAVENOUS 209387-002 Dec 7, 2017 DISCN Yes 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

Investment Scenario and Fundamentals Analysis for NIPRIDE (Nipride, Nitroprusside)

Last updated: February 20, 2026

What Are the Core Clinical and Market Drivers of NIPRIDE?

NIPRIDE (nitroprusside) is a potent vasodilator indicated for acute hypertensive crises and heart failure with pulmonary congestion. It exerts rapid-onset arterial and venous dilation, lowering blood pressure within minutes. Its clinical usage is primarily in emergency and intensive care settings where immediate blood pressure control is required.

What Is the Market Size and Growth Potential?

The global hypertension market was valued at approximately USD 32 billion in 2022, with critical care segments representing USD 4-6 billion driven by hospital admissions requiring vasodilators. Nitroprusside's market share within this sub-sector is limited due to existing alternatives and challenges related to safety, stability, and administration protocols.

Growth predictions rely on the following factors:

  • Continued prevalence of hypertension and heart failure.
  • Increasing hospital admissions for hypertensive emergencies.
  • Trends toward more aggressive blood pressure management in critical care.

Projections estimate the critical care vasodilator market to grow at a CAGR of 4-5% through 2030.

What Are the Competitive Dynamics and Key Players?

NIPRIDE faces competition from:

  • Fenoldopam and clevidipine as alternative vasodilators for hypertensive emergencies.
  • Use of oral antihypertensives post-critical phase.
  • Generic versions of nitroprusside, reducing pricing power.

Major suppliers include:

  • Hospira (now part of Pfizer)
  • Faulding
  • Sagent Pharmaceuticals

Generic availability pressures pricing, impacting margins for proprietary formulations.

What Are the Regulatory and Patent Status Considerations?

  • Nitroprusside is off-patent; original patents expired decades ago.
  • Regulatory approvals are widespread; no recent major regulatory interventions.
  • No recent patent filings or exclusivity protections. Future innovation would likely rely on new formulations or delivery systems.

What Are the Key Manufacturing and Safety Challenges?

  • Nitroprusside degrades in solution, requiring careful handling and storage.
  • Toxicity concerns include cyanide and thiocyanate release, necessitating monitoring during infusion.
  • This safety profile limits wider adoption and complicates manufacturing and supply chain logistics.

What Are the R&D and Innovation Opportunities?

Potential avenues include:

  • Developing safer cost-effective formulations.
  • Novel delivery systems, such as controlled-release or infusion pumps.
  • Combination therapies reducing toxic metabolites.
  • These strategies require significant investment with uncertain regulatory and clinical approval outcomes.

Financial Implications and Investment Risks

  • Low-margin commodity drug with declining profitability due to generics.
  • Limited patent protection minimizes potential for premium pricing.
  • Market growth driven by healthcare infrastructure expansion and hypertension management trends.
  • Supply chain challenges and safety concerns remain barriers to broader utilization.

Key Financial Metrics and Valuation Benchmarks

Metric Data Point Source/Comment
Market Size USD 4-6 billion (critical care vasodilators) Threaded from multiple industry reports (IQVIA, 2022)
CAGR 4-5% (critical care vasodilator segment) Market research forecasts (Research and Markets, 2023)
Patent Status Off-patent Historical patent filings, expired decades ago
Cost of Goods (COGS) Estimated low Generic manufacturing process, scaled cost efficiencies apply
Pricing Subject to regional variation and hospital negotiations Price erosion typical for off-patent injectables

Investment Outlook Summary

NIPRIDE's market is mature with declining margins, primarily due to generic competition. Growth hinges on expanding clinical indications and innovations to address safety shortcomings. Valuation should consider low profitability, supply chain considerations, and regulatory stability inherent in off-patent drugs.

Key Takeaways

  • NIPRIDE is a critical care drug with established clinical use but limited growth prospects due to patent expiration and generic competition.
  • The market is characterized by slow growth, constrained margins, and safety concerns that limit broader adoption.
  • Innovation opportunities exist mainly in formulation and delivery systems, requiring substantial R&D investment.
  • The drug's value is largely derived from its essential role in emergency hypertensive management rather than premium pricing.
  • Investors should weigh the steady but limited revenue potential against the risks of supply chain complexity and safety-related liabilities.

FAQs

  1. What are the primary clinical uses of NIPRIDE?
    Acute hypertensive crises and acute heart failure management in hospital settings.

  2. Is there potential for patent protection or exclusive rights?
    No; the original patents have expired, leaving the drug open for generic manufacturing.

  3. What are the main safety concerns with NIPRIDE?
    Cyanide and thiocyanate toxicity, requiring careful dosing and monitoring.

  4. Can newer formulations improve its market position?
    Yes; innovations like controlled-release forms could address safety concerns but demand significant R&D expenditure.

  5. What is the outlook for NIPRIDE’s market share?
    Stable, but declining in the face of alternative therapies and generics, with limited growth potential in current formulations.

References

  1. IQVIA. (2022). Global hypertension market report.
  2. Research and Markets. (2023). Critical care vasodilator market forecast.

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