NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE Drug Patent Profile

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When do Nicardipine Hydrochloride In 0.86% Sodium Chloride patents expire, and what generic alternatives are available?

Nicardipine Hydrochloride In 0.86% Sodium Chloride is a drug marketed by Inforlife and is included in one NDA.

The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE is nicardipine hydrochloride. There is one drug master file entry for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nicardipine Hydrochloride In 0.86% Sodium Chloride

A generic version of NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE was approved as nicardipine hydrochloride by ANI PHARMS on October 28^th, 1996.

Summary for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	59
DailyMed Link:	NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

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

Sponsor	Phase
Wake Forest University Health Sciences	PHASE4
Universitas Sumatera Utara	NA
VZW Cardiovascular Research Center Aalst	PHASE4

See all NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE clinical trials

Pharmacology for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

US Patents and Regulatory Information for NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Inforlife	NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE	nicardipine hydrochloride	INJECTABLE;INTRAVENOUS	203978-001	Apr 17, 2024	AP	RX	No	No

Nicardipine Hydrochloride in 0.86% Sodium Chloride: Market Dynamics, Competition, and Financial Trajectory

Last updated: October 20, 2026

Nicardipine hydrochloride in 0.86% sodium chloride is a hospital-use, premixed intravenous calcium-channel blocker used for short-term blood-pressure control. Its commercial profile is driven by critical-care utilization, sterile-injectable manufacturing capacity, hospital contracting, and supply reliability rather than patent exclusivity. The product has limited brand pricing power, no meaningful biosimilar exposure, and a financial trajectory tied to generic injectable market conditions.

What is nicardipine hydrochloride in 0.86% sodium chloride?

Nicardipine hydrochloride in 0.86% sodium chloride is a ready-to-use intravenous infusion containing nicardipine hydrochloride in a sodium chloride vehicle. The formulation is supplied in concentrations commonly equivalent to:

Product strength	Typical presentation	Clinical use
20 mg/200 mL	0.1 mg/mL	Continuous IV infusion
40 mg/200 mL	0.2 mg/mL	Continuous IV infusion

The product is administered in hospitals and intensive-care settings when rapid, titratable blood-pressure reduction is required. FDA labeling identifies use in short-term treatment of hypertension when oral therapy is not feasible or desirable, including perioperative and acute-care settings. It is not a chronic outpatient product.[1]

Nicardipine is a dihydropyridine calcium-channel blocker. The intravenous formulation permits rapid dose adjustment through continuous infusion. Its primary clinical competitors include clevidipine injection, esmolol injection, labetalol injection, and sodium nitroprusside, although these products have different mechanisms, monitoring requirements, and patient-selection profiles.

What is the FDA regulatory status of nicardipine hydrochloride injection?

Nicardipine hydrochloride injection is an FDA-approved generic prescription drug. The product is marketed through abbreviated new drug application, or ANDA, pathways rather than through a new drug application supported by novel active-ingredient development.

The relevant regulatory characteristics are:

Regulatory attribute	Status
Active ingredient	Nicardipine hydrochloride
Dosage form	Intravenous injection for infusion
FDA pathway	Generic injectable approval, generally through ANDA
Therapeutic category	Antihypertensive; calcium-channel blocker
Hospital setting	ICU, emergency department, operating room, perioperative care
Biosimilar pathway	Not applicable
Prescription status	Prescription-only
Orange Book relevance	Product-specific listings may exist for approved applicants; no major active innovator patent barrier is generally associated with the generic premix

FDA-approved labeling requires controlled intravenous administration, blood-pressure monitoring, and appropriate dilution or infusion handling depending on the presentation. Premixed products reduce bedside preparation requirements compared with concentrate formulations.[1]

What patents protect nicardipine hydrochloride in 0.86% sodium chloride?

The commercial product is not principally protected by an active composition-of-matter patent. Nicardipine hydrochloride is an established small-molecule active ingredient, and the original innovator protection for nicardipine products has expired.

Patent protection relevant to a current generic premix would more likely involve:

• Container and closure systems
• Premixed intravenous delivery systems
• Stability and impurity-control methods
• Manufacturing processes
• Packaging configurations
• Formulation-specific concentration or storage claims

These rights are distinct from a basic patent on nicardipine hydrochloride. They may affect a particular manufacturer but do not ordinarily prevent competing companies from selling the active ingredient in an approved sodium chloride infusion.

How strong is the patent estate for the product?

The patent estate is weak from an exclusivity perspective and moderate from an operational perspective.

Patent category	Commercial relevance
Active-ingredient patent	Minimal; historical protection has expired
Method-of-use patent	Limited for a mature hospital antihypertensive
Formulation patent	Potentially relevant to specific premixed presentations
Container patent	Potentially relevant to flexible bags and sterile packaging
Manufacturing patent	May create process-level barriers
Orange Book blocking patent	No widely recognized blocking patent barrier for generic market entry
Trade-secret protection	Can protect process know-how, scale-up, and sterility controls

A formulation or packaging patent could support litigation against a particular product configuration. It would not necessarily prevent alternative formulations, concentrations, containers, or manufacturing methods.

When does nicardipine hydrochloride lose exclusivity?

Nicardipine lost effective market exclusivity before the current generic hospital market developed. The product is therefore in the post-exclusivity phase.

Exclusivity factor	Current position
New chemical entity exclusivity	Expired
Original brand patent protection	Expired
Generic entry	Established
First generic advantage	No longer relevant
Pediatric exclusivity	Not a current market barrier
Regulatory exclusivity	No current exclusivity expected to block routine generic entry

The economic issue is not future loss of exclusivity. It is the erosion of generic margins through bidding, wholesaler substitution, group purchasing organization contracts, and competing ready-to-use critical-care products.

How many companies compete in the nicardipine injection market?

The market includes branded legacy products, generic concentrate injections, and premixed products. The active competitive set can vary by hospital formulary and shortage conditions.

Companies associated with hospital injectable nicardipine products or broader generic injectable distribution have included:

• Pfizer and Hospira
• Hikma Pharmaceuticals
• Fresenius Kabi
• Sagent Pharmaceuticals, historically
• Other ANDA holders and contract manufacturers

The relevant distinction is between:

1. Nicardipine concentrate requiring pharmacy preparation.
2. Nicardipine premixed in sodium chloride.
3. Alternative IV antihypertensives used in the same clinical protocols.

A manufacturer with an approved premixed bag can compete for a different purchasing slot from a company offering only a vial or concentrate. Hospitals often value reduced preparation time, lower compounding burden, and lower risk of medication-preparation error.

What formulations are protected by the product’s commercial position?

The principal commercial differentiation is the ready-to-use sodium chloride presentation rather than a new pharmacologic mechanism.

Premixed intravenous bag

The premixed bag is designed to support direct connection to an infusion system after standard inspection and line preparation. Its advantages include:

• Reduced pharmacy compounding
• Lower handling burden in emergency settings
• More predictable concentration
• Lower exposure to compounding workflow interruptions
• Potential reduction in preparation errors

The product must maintain chemical stability, sterility, container compatibility, and acceptable particulate performance during storage and administration. These requirements create manufacturing and quality barriers even when patent protection is limited.

Concentrate injection

Concentrate formulations are generally less differentiated on price and may require dilution before use. They can remain commercially relevant because hospitals may already have standardized preparation protocols or may prefer vial-based inventory for lower-volume use.

Concentration selection

A 20 mg/200 mL presentation provides a lower concentration for infusion titration. A 40 mg/200 mL presentation can reduce fluid volume at the same delivered dose. Hospitals may purchase both depending on ICU protocols, fluid-management requirements, and infusion-pump standards.

What is the competitive position versus clevidipine?

Clevidipine is the closest branded or premium-priced comparator in acute blood-pressure management. Nicardipine competes on clinical familiarity, generic availability, and lower acquisition cost.

Factor	Nicardipine IV	Clevidipine IV
Drug class	Dihydropyridine calcium-channel blocker	Dihydropyridine calcium-channel blocker
Market status	Generic and legacy branded supply	Branded product, Cleviprex
Vehicle	Sodium chloride presentations available	Lipid emulsion
Formulation	Concentrate and premixed products	Ready-to-use injectable emulsion
Cost position	Generally lower	Generally higher
Hospital role	Broad ICU and perioperative use	Premium alternative for rapid titration
Supply economics	Generic injectable pricing	Branded pricing and contracting
Patent exposure	Mature, low	Product-specific patent and exclusivity history more relevant

Clevidipine can retain share where clinicians value its rapid titration characteristics or where hospital protocols favor it. Nicardipine remains better positioned in cost-sensitive formularies and hospitals with established use pathways.

Labetalol and esmolol compete in patients where beta-blockade is clinically appropriate. Sodium nitroprusside remains an option for rapid vasodilation but carries different monitoring and toxicity considerations.

What drives market demand for nicardipine injection?

Demand is concentrated in hospital episodes rather than recurring retail prescriptions. Key volume drivers include:

• Neurocritical-care blood-pressure control
• Intracerebral hemorrhage and ischemic stroke protocols
• Perioperative hypertension
• Postoperative hypertension
• Aortic and vascular surgery settings
• Emergency-department hypertensive crises
• Intensive-care titration when oral therapy is temporarily unavailable

Clinical guidelines and institutional protocols influence demand more than consumer marketing. In neurocritical care, clinicians may use nicardipine when controlled reduction of blood pressure is required and continuous titration is preferred.

The product has limited exposure to seasonal consumer demand. Volume can rise with hospital admissions, procedural activity, and protocol adoption, but the product is not materially driven by outpatient prescription growth.

What are the main market risks?

The largest commercial risks are manufacturing and procurement risks rather than patent litigation.

Sterile-injectable supply risk

Ready-to-use injectable products require validated aseptic processing, container integrity, sterilization controls, and reliable access to pharmaceutical-grade components. A manufacturing interruption can cause rapid hospital substitution because customers typically maintain limited inventory for critical-care products.

Hospital contracting pressure

Hospitals and group purchasing organizations negotiate aggressively. A supplier may gain volume through a contract while accepting lower net prices. Price competition is particularly intense when multiple approved suppliers have available capacity.

Product substitution

Hospitals can substitute:

• Another nicardipine manufacturer
• Nicardipine concentrate
• Clevidipine
• Labetalol
• Esmolol
• Sodium nitroprusside

Substitution depends on clinical protocols, inventory, price, and supply status.

Formulary concentration

A hospital may standardize on one supplier for operational simplicity. This creates switching barriers but also increases purchasing concentration risk for the incumbent supplier. Loss of a group purchasing contract can produce a sharp volume decline.

Manufacturing and quality events

FDA warning letters, recalls, inspection findings, particulate contamination, container defects, or shortage notifications can materially affect market share. For a generic injectable, product quality and supply consistency often matter more than brand recognition.

Which companies are challenging the product’s market position?

Competition is primarily commercial rather than litigation-based. The relevant challengers are manufacturers with:

• Approved nicardipine injection products
• Premixed sodium chloride presentations
• Existing hospital injectable sales infrastructure
• Access to group purchasing contracts
• Reliable sterile-manufacturing capacity

Clevidipine's manufacturer competes for the same hospital treatment decisions but does not represent a traditional generic Paragraph IV challenge to nicardipine.

What Paragraph IV challenges affect nicardipine hydrochloride injection?

No major current Paragraph IV event is central to the established nicardipine hydrochloride injection market. Paragraph IV litigation is more relevant during the initial generic-entry period for a product with unexpired Orange Book patents.

For current nicardipine premix products, market entry is more likely to depend on:

• ANDA approval
• Paragraph III or certification positions where applicable
• Manufacturing readiness
• FDA inspection outcomes
• Supply-chain capacity
• Hospital contracting

The absence of a major active patent dispute reduces legal entry risk but increases price competition.

What is the Orange Book status of nicardipine hydrochloride injection?

The Orange Book identifies FDA-approved prescription drug products and, where applicable, patents and exclusivity information. For a mature generic injectable, the Orange Book is relevant for confirming approved products and any applicant-specific patent certifications. It is not generally a source of durable market exclusivity for nicardipine premix products.

The practical Orange Book conclusion is:

• The active ingredient is mature.
• Original innovator exclusivity is expired.
• Generic products can compete through ANDA approval.
• Product-specific patents, if listed, must be evaluated by presentation and applicant.
• No broad Orange Book barrier is known to prevent generic competition in the category.[2]

What patent litigation affects nicardipine hydrochloride in sodium chloride?

No material, market-defining patent litigation is publicly associated with the established generic nicardipine premix category in the available public record. Litigation risk is more likely to arise from:

• Manufacturing process patents
• Container or infusion-bag rights
• Trade-secret disputes
• Contract disputes
• Product-liability claims
• FDA compliance actions
• Commercial disputes over supply or distribution

These matters can affect a single supplier without changing the overall generic market structure.

What is the financial trajectory for nicardipine hydrochloride injection?

Product-specific revenue is generally not disclosed separately by manufacturers. Public company filings usually report broad segments such as generic injectables, hospital products, or North American generics rather than revenue for one concentration or container presentation.

The likely financial trajectory is a mature generic profile:

Period	Expected market condition	Financial effect
Initial generic expansion	Supplier entry and hospital conversion	Volume growth, price decline
Mature competition	Multiple suppliers and contract bidding	Stable or declining net price
Shortage periods	Limited supply and substitution	Temporary price and volume uplift
Capacity normalization	Returning supplier competition	Margin compression
Long-term mature phase	Low innovation and recurring hospital use	Stable demand, modest pricing power

Revenue is likely to be more stable than that of an acute branded launch but less profitable than a protected specialty product. A supplier can improve economics through:

• Premixed presentation premiums
• Reliable fill rates
• Dual concentrations
• Direct hospital contracts
• GPO access
• Portfolio bundling with other injectable products
• Lower manufacturing costs
• Reduced preparation burden for customers

The financial upside is limited by generic competition. The main earnings variable is share and supply reliability, not expansion of the treatment population.

What generic launch scenarios exist?

Base case

Several suppliers remain available, hospital demand continues, and net prices gradually decline. Volume is stable because nicardipine remains embedded in acute-care protocols. EBITDA depends on manufacturing efficiency and contract retention.

Upside case

A competitor experiences a shortage, recall, or capacity interruption. The remaining supplier gains temporary volume and may obtain improved pricing. The effect is usually reversible once supply normalizes.

Downside case

A large hospital contract is lost, additional suppliers enter, or the product is displaced by clevidipine or another protocol-preferred agent. Prices and market share decline together.

Manufacturing-risk case

A quality event or FDA action removes a supplier from the market. The event can reduce near-term revenue but increase demand for unaffected competitors. Recovery depends on remediation timing and hospital confidence.

What is the geographic coverage of the market?

The United States is the most relevant market for the specified presentation because the product is tied to FDA-approved hospital injectable supply and U.S. purchasing channels. Commercial coverage depends on:

• FDA approval
• National Drug Code assignment
• Wholesale distribution
• GPO contracts
• State hospital procurement
• Sterile manufacturing location
• Import and supply-chain authorization

International markets may use different container sizes, concentrations, labeling, or sodium chloride specifications. U.S. commercial performance should not be extrapolated directly to Europe, Canada, or emerging markets.

How strong is the commercial position of the product?

The product has a moderate commercial position and a weak legal exclusivity position.

Dimension	Assessment
Clinical demand	Moderate and recurring
Patent strength	Low
Regulatory barrier	Moderate because sterile injectable approval is demanding
Manufacturing barrier	Moderate to high
Pricing power	Low
Switching risk	Moderate
Shortage upside	Meaningful but temporary
Biosimilar risk	None
Generic-entry risk	High historically; ongoing price competition
Revenue predictability	Moderate
Long-term growth	Low

The strongest defensible asset is dependable sterile supply in a preferred ready-to-use presentation. The weakest element is pricing power because the active ingredient is mature and substitution is available.

Key Takeaways

• Nicardipine hydrochloride in 0.86% sodium chloride is a mature hospital injectable with recurring ICU and perioperative demand.
• The product is primarily a generic-market opportunity, not a patent-exclusivity opportunity.
• Orange Book and Paragraph IV risks are limited compared with the commercial risks of pricing, contracting, supply interruption, and manufacturing quality.
• Premixed bags can command operational value because they reduce pharmacy preparation and support rapid use.
• Clevidipine is the closest premium competitor, while labetalol, esmolol, and sodium nitroprusside provide clinical alternatives.
• Product-specific revenue is not generally reported publicly; financial performance is best assessed through injectable segment results, contract wins, supply status, and market-share indicators.
• The base-case financial trajectory is stable or modestly declining pricing with recurring volume and periodic shortage-driven upside.
• Manufacturing reliability, FDA compliance, and GPO access are more important than patent strength.

FAQs

Is nicardipine hydrochloride in sodium chloride a branded or generic drug?

It is generally marketed as a generic hospital injectable, although the original Cardene brand established the product category.

Does nicardipine premix have biosimilar competition?

No. Nicardipine hydrochloride is a small-molecule drug, so biosimilar regulation does not apply. Competition comes from generic injectables and alternative antihypertensive drugs.

Can a new supplier enter the nicardipine premix market without an active ingredient patent?

Yes, subject to FDA approval, sterile manufacturing requirements, product quality controls, applicable patent certifications, and commercial distribution capability.

Why can nicardipine injection prices rise despite expired patents?

Hospital injectable prices can rise temporarily when one or more suppliers face shortages, recalls, manufacturing failures, or distribution interruptions.

What makes the 0.86% sodium chloride presentation commercially valuable?

The premixed sodium chloride presentation reduces bedside preparation and may improve workflow in emergency, ICU, and perioperative settings. Its value is operational rather than based on novel pharmacology.

References

1. U.S. Food and Drug Administration. (2023). Nicardipine hydrochloride injection prescribing information. FDA/DailyMed labeling.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

3. U.S. Food and Drug Administration. (2024). Drug shortages: Nicardipine hydrochloride injection. FDA Drug Shortages Database.

4. American Heart Association. (2022). Guidelines for the management of patients with spontaneous intracerebral hemorrhage. Stroke, 53(7), e282-e361.

5. Pfizer Inc. (2024). Annual report and Form 10-K. Pfizer investor relations.

6. Hikma Pharmaceuticals PLC. (2024). Annual report and accounts. Hikma investor relations.

7. Fresenius Kabi AG. (2024). Annual report. Fresenius Kabi.