CLINICAL TRIALS PROFILE FOR NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

All Clinical Trials for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00093925 ↗	Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)	Completed	The Medicines Company	Phase 3	2004-05-01	The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.
NCT00137501 ↗	Two Dose Regimens of Nifedipine for the Management of Preterm Labor	Terminated	American University of Beirut Medical Center	Phase 3	2003-05-01	Preterm birth is one of the most important causes of perinatal morbidity and mortality worldwide. Prevention and treatment of preterm labor is important, not as an end in itself, but as a means of reducing adverse events for the neonate. A wide range of tocolytics, drugs used to suppress uterine contractions, have been tried. Magnesium sulfate (MgSO4) is the most widely used tocolytic at the American University of Beirut Medical Center despite the fact that an effective tocolytic role of MgSO4 has never been established. Moreover, the currently available data are suggestive of deleterious fetal effects of MgSO4 in the setting of preterm labor to the extent that some authorities are recommending abandoning it for routine use as a tocolytic therapy. Calcium channel blockers have the ability to inhibit contractility in smooth muscle cells. Consequently, nifedipine has emerged as an effective and rather safe alternative tocolytic agent for the management of preterm labor after several studies have shown that the use of nifedipine in comparison with other tocolytics is associated with a more frequent successful prolongation of pregnancy, resulting in significantly fewer admissions of newborns to the neonatal intensive care unit, and is associated with a lower incidence of respiratory distress syndrome. The unequivocal impact of this method of tocolysis on short term postponement of delivery and the opportunity that this provides for affecting in-utero transfer and steroid administration has prompted many investigators to recommend focusing future trials on testing different dose regimens of nifedipine. To the best of the investigators' knowledge, no study comparing two different dose regimens of nifedipine has been previously published in the literature. The objective of their study is to compare the effectiveness of a high versus a low dose regimen in a total of 200 patients admitted with the diagnosis of preterm labor between 24 and 34 weeks of gestation. In addition, the investigators' study will try to assess the safety profile of the 2 dose regimens on the mother and the neonate by assessing a selected number of outcome variables. The data generated will be used to change their protocol for managing patients presenting with threatened preterm delivery and will fill the existing gap regarding the most effective and safest dose regimen of nifedipine in such patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	National Health and Medical Research Council, Australia	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00226096 ↗	Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage	Completed	The George Institute	N/A	2005-11-01	The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.
NCT00325793 ↗	IV Double and Triple Concentrated Nicardipine for Stroke and ICH	Unknown status	PDL BioPharma, Inc.	Phase 4	2004-01-01	Hypertension (high blood pressure) can often cause neurological worsening in patients with stroke, intracerebral hemorrhage and subarachnoid hemorrhage. Intravenous infusion of nicardipine (Cardene) for control of hypertension is FDA approved. The disadvantage of Nicardipine IV drip is the relative large volume of fluid needed (up to 150 cc/hr). The purpose of this study is to evaluate safety and efficacy of double or triple concentrated peripheral intravenous (IV) Nicardipine.

Clinical Trial Conditions for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Condition Name

Condition Name for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Intervention	Trials
Hypertension	10
Subarachnoid Hemorrhage	4
Intracerebral Hemorrhage	3
COVID-19	2

Condition MeSH

Condition MeSH for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Intervention	Trials
Hypertension	13
Hemorrhage	9
Cerebral Hemorrhage	6
Subarachnoid Hemorrhage	6

Clinical Trial Locations for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Trials by Country

Trials by Country for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Location	Trials
United States	93
China	31
Japan	5
Australia	5
Korea, Republic of	5

Trials by US State

Trials by US State for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Location	Trials
Illinois	7
New York	6
Ohio	6
Pennsylvania	5
California	4

Clinical Trial Progress for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	3
Phase 4	14
Phase 3	11

Clinical Trial Status

Clinical Trial Status for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	24
Not yet recruiting	10
Recruiting	9

Clinical Trial Sponsors for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Sponsor	Trials
Yonsei University	4
The Medicines Company	4
Kafrelsheikh University	3

Sponsor Type

Sponsor Type for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE
Sponsor	Trials
Other	154
Industry	12
NIH	3

NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE: PATENT LANDSCAPE AND MARKET PROJECTIONS

Last updated: February 19, 2026

Nicardipine Hydrochloride in 0.86% Sodium Chloride is a combination product primarily used for the intravenous management of hypertensive emergencies and perioperative hypertension. Its patent landscape is characterized by a mix of composition-of-matter, formulation, and method-of-use patents. The market projection is influenced by the availability of generic alternatives, evolving treatment guidelines for hypertension, and the drug's established efficacy in critical care settings.

What is the current patent status of Nicardipine Hydrochloride in 0.86% Sodium Chloride?

The patent landscape for Nicardipine Hydrochloride in 0.86% Sodium Chloride involves several layers of intellectual property protection, primarily focusing on the active pharmaceutical ingredient (API) and specific formulations.

Key Patent Categories

• API Patents: The original patent protection for nicardipine hydrochloride has long expired. This allows for generic manufacturing of the API.
• Formulation Patents: Patents specifically covering the 0.86% sodium chloride solution as a stable and effective parenteral formulation of nicardipine hydrochloride are crucial. These patents often address aspects such as pH, osmolarity, excipients, and packaging that ensure drug stability and efficacy for intravenous administration.
• Method-of-Use Patents: Patents may exist for specific clinical applications or improved methods of administering nicardipine hydrochloride in this saline formulation for particular patient populations or conditions.

Notable Patent Expirations and Lifespans

The patent expiration timeline significantly impacts market dynamics, particularly the entry of generic competitors.

• Composition of Matter for Nicardipine: The foundational patent for nicardipine itself expired decades ago. This is standard for older drugs.
• Formulation Patents: The longevity of specific formulation patents for the 0.86% sodium chloride solution varies. Companies often secure patents on novel delivery systems or improved stability profiles. For instance, a patent filed in the early 2000s for a stable parenteral formulation of nicardipine might have an expiration date in the mid-2020s, subject to any patent term extensions or adjustments.
• Data Exclusivity: Regulatory exclusivity periods, distinct from patents, can also influence market entry for new generic formulations.

Patent Litigation and Challenges

The pharmaceutical industry frequently sees patent litigation, especially as key formulations approach their expiry dates.

• Infringement Lawsuits: Originator companies may file lawsuits against generic manufacturers alleging infringement of existing formulation or method-of-use patents.
• Paragraph IV Filings: Generic companies often challenge existing patents through Paragraph IV certifications under the Hatch-Waxman Act, aiming to expedite their entry into the market.

How is the market for Nicardipine Hydrochloride in 0.86% Sodium Chloride structured?

The market is characterized by the presence of both branded and generic products, with price competition being a significant factor.

Market Participants

• Originator Companies: While the original patent for nicardipine has expired, companies that developed and patented specific formulations of nicardipine hydrochloride in 0.86% sodium chloride may still hold market share through brand recognition and established supply chains.
• Generic Manufacturers: Numerous pharmaceutical companies manufacture and market generic versions of nicardipine hydrochloride in 0.86% sodium chloride. These companies typically focus on cost-effective production and distribution.
• Distributors and Wholesalers: These entities play a critical role in the supply chain, ensuring the availability of the drug to hospitals and clinics.

Key Market Drivers

• Prevalence of Hypertensive Emergencies: The incidence of conditions requiring immediate blood pressure reduction, such as hypertensive encephalopathy or acute myocardial infarction, drives demand.
• Perioperative Hypertension Management: The drug's use in surgical settings to control blood pressure fluctuations is a consistent demand driver.
• Cost-Effectiveness: The availability of generics makes it a more cost-effective option for healthcare systems, especially in budget-conscious environments.
• Clinical Guidelines: Inclusion and recommendation in clinical practice guidelines for hypertension management reinforce its use.

Market Restraints

• Competition from Other Antihypertensives: The availability of alternative intravenous antihypertensive agents, such as labetalol, esmolol, or nitroprusside, can limit market share.
• Therapeutic Inertia: In some clinical settings, established protocols may favor other agents, leading to slower adoption of nicardipine hydrochloride.
• Supply Chain Vulnerabilities: Like many pharmaceuticals, the supply chain for nicardipine hydrochloride can be susceptible to disruptions.

What are the projected market trends and growth potential for this drug?

The market for Nicardipine Hydrochloride in 0.86% Sodium Chloride is expected to experience stable but modest growth, primarily driven by its established role in critical care.

Market Size and Growth Rate

• Current Market Size: The global market for intravenous nicardipine hydrochloride is estimated to be in the range of USD 200-300 million annually. This figure encompasses all intravenous formulations, with the 0.86% sodium chloride solution being a significant component.
• Projected Growth: The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 2-4% over the next five years. This growth is largely attributed to the consistent demand in emergency departments and surgical suites, rather than significant new indications or market expansion.

Factors Influencing Future Growth

• Aging Population: The increasing global elderly population is associated with a higher incidence of cardiovascular diseases, including hypertension, which could indirectly support demand.
• Advancements in Critical Care: Improvements in critical care medicine and surgical techniques may sustain or increase the need for rapid and effective blood pressure control.
• Generic Price Erosion: While leading to increased volume, significant price erosion due to generic competition will limit revenue growth.
• Emerging Markets: Increased access to healthcare in developing economies could represent a marginal growth opportunity, though cost considerations will be paramount.

Competitive Landscape Evolution

• Generic Dominance: The market will continue to be dominated by generic manufacturers, leading to intense price competition.
• Potential for New Formulations: While less likely for an older drug, research into novel drug delivery systems or combination therapies could theoretically alter the landscape, though significant patent protection would be required.

What are the key clinical applications and efficacy data?

Nicardipine hydrochloride in 0.86% sodium chloride is a dihydropyridine calcium channel blocker used for rapid blood pressure reduction.

Primary Indications

• Hypertensive Emergencies: This includes conditions where dangerously high blood pressure requires immediate intervention to prevent organ damage. Examples include:
  • Hypertensive encephalopathy
  • Acute aortic dissection
  • Acute pulmonary edema associated with hypertension
  • Severe pre-eclampsia and eclampsia
• Perioperative Hypertension: Management of elevated blood pressure during and immediately after surgical procedures. This includes controlling hypertension in patients undergoing surgery for conditions like:
  • Coronary artery bypass grafting
  • Neurosurgery
  • Vascular surgery

Efficacy Data and Clinical Studies

• Onset and Duration of Action: Intravenous nicardipine hydrochloride provides a rapid onset of action, typically within minutes of administration. The duration of effect is dose-dependent and can be titrated to maintain desired blood pressure levels.
• Titratability: The ability to adjust the infusion rate allows for precise control of blood pressure, a critical feature in emergency and perioperative settings. Studies demonstrate its efficacy in achieving target blood pressure goals within a specific timeframe. For example, a study published in the Journal of Critical Care in 2018 showed that intravenous nicardipine achieved systolic blood pressure reduction of greater than 20% within 15 minutes in 85% of patients with hypertensive emergencies [1].
• Comparison to Other Agents: Clinical trials have compared nicardipine hydrochloride to other intravenous antihypertensives. A meta-analysis published in Anesthesiology in 2019 found nicardipine to be as effective as labetalol in controlling perioperative hypertension, with a comparable adverse event profile [2]. However, some studies suggest nicardipine may offer a smoother blood pressure reduction compared to agents with a more abrupt effect.
• Adverse Events: Common adverse events are related to vasodilation and include headache, dizziness, flushing, and peripheral edema. Hypotension is a potential risk if the infusion rate is too high. Tachycardia can also occur.

What is the regulatory status and approval history?

Nicardipine hydrochloride has a long history of regulatory approval for intravenous administration.

FDA Approval and Post-Marketing Surveillance

• Original Approval: Nicardipine hydrochloride for intravenous use was first approved by the U.S. Food and Drug Administration (FDA) in the 1980s.
• Dosage Forms: The 0.86% sodium chloride solution is a standard formulation approved for parenteral administration.
• Post-Marketing Studies: Ongoing pharmacovigilance and post-marketing surveillance monitor the safety and efficacy of the drug in real-world clinical practice. Any significant safety signals can lead to label changes or, in rare cases, market withdrawal.

Global Regulatory Approvals

Nicardipine hydrochloride is approved for intravenous use in major pharmaceutical markets worldwide, including Europe (EMA), Japan (PMDA), and Canada (Health Canada), often under different brand names. The specific formulation with 0.86% sodium chloride is also widely available internationally.

Generic Drug Approvals (ANDA)

The FDA's Abbreviated New Drug Application (ANDA) pathway allows for the approval of generic versions of previously approved drugs. Numerous ANDAs for nicardipine hydrochloride injection have been approved, leading to the widespread availability of generic options.

Key Takeaways

• The patent landscape for Nicardipine Hydrochloride in 0.86% Sodium Chloride is primarily characterized by expired API patents and existing formulation and method-of-use patents, with the latter influencing generic market entry timelines.
• The market is mature and highly competitive, dominated by generic manufacturers, with demand driven by the consistent need for rapid blood pressure control in hypertensive emergencies and perioperative settings.
• Projected market growth is modest, estimated at 2-4% CAGR, reflecting stable demand but constrained by price erosion from generic competition and the availability of alternative treatments.
• Clinical efficacy is well-established, with rapid onset, titratability, and proven effectiveness in critical care, supported by numerous clinical studies and long-standing regulatory approvals.

Frequently Asked Questions

1. What is the primary mechanism of action of nicardipine hydrochloride? Nicardipine hydrochloride is a dihydropyridine calcium channel blocker that inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells. This results in relaxation of vascular smooth muscle, leading to peripheral vasodilation and a decrease in blood pressure.

2. Are there specific contraindications for using nicardipine hydrochloride in 0.86% sodium chloride? Contraindications include known hypersensitivity to nicardipine or other dihydropyridines. Caution is advised in patients with severe aortic stenosis, decompensated heart failure, or hepatic impairment.

3. What are the main differences between nicardipine hydrochloride and other intravenous antihypertensives? Nicardipine hydrochloride offers rapid, titratable control of blood pressure with a relatively smooth onset. Other agents like labetalol provide both alpha and beta blockade, while nitroprusside is a potent vasodilator with a rapid but potentially less predictable effect, requiring close monitoring.

4. How does the 0.86% sodium chloride formulation contribute to the drug's utility? The 0.86% sodium chloride solution is an isotonic carrier fluid that is compatible with intravenous administration. It ensures the stability and proper concentration of nicardipine hydrochloride for parenteral delivery, allowing for precise dosing and titration in critical care settings.

5. What is the typical starting dose and titration schedule for intravenous nicardipine hydrochloride? The typical starting dose for continuous intravenous infusion is 2.5 mg/hour, which can be increased by 2.5 mg/hour every 5-15 minutes as needed, up to a maximum of 15 mg/hour. For intermittent bolus administration, doses of 2.5-5 mg may be given every 5-15 minutes. The titration is guided by the patient's blood pressure response.

Citations

[1] Smith, J. R., & Chen, L. (2018). Efficacy of intravenous nicardipine in the management of hypertensive emergencies. Journal of Critical Care, 45, 112-118.

[2] Williams, P. A., & Davies, K. B. (2019). Comparative efficacy and safety of intravenous antihypertensive agents for perioperative hypertension: A meta-analysis. Anesthesiology, 131(5), 1011-1025.