Last Updated: May 10, 2026

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Drug Patent Profile


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When do Cardene In 0.86% Sodium Chloride In Plastic Container patents expire, and what generic alternatives are available?

Cardene In 0.86% Sodium Chloride In Plastic Container is a drug marketed by Chiesi and is included in one NDA. There are six patents protecting this drug.

This drug has twenty-one patent family members in ten countries.

The generic ingredient in CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is nicardipine hydrochloride. There are eleven drug master file entries 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 Cardene In 0.86% Sodium Chloride In Plastic Container

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

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Summary for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
Recent Clinical Trials for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

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

SponsorPhase
Boston Medical CenterPhase 4
National Institute of Neurological Disorders and Stroke (NINDS)Phase 2
University of CincinnatiPhase 2

See all CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER is protected by six US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes 7,659,291 ⤷  Start Trial ⤷  Start Trial
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes 9,364,564 ⤷  Start Trial Y ⤷  Start Trial
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes 8,455,524 ⤷  Start Trial ⤷  Start Trial
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes 11,547,758 ⤷  Start Trial ⤷  Start Trial
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes 10,758,616 ⤷  Start Trial Y ⤷  Start Trial
Chiesi CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER nicardipine hydrochloride INJECTABLE;INTRAVENOUS 019734-003 Jul 31, 2008 AP RX Yes Yes 7,612,102 ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

See the table below for patents covering CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER around the world.

Country Patent Number Title Estimated Expiration
Austria 63810 ⤷  Start Trial
Australia 2007237903 ⤷  Start Trial
Germany 2407115 ⤷  Start Trial
South Korea 20090040258 ⤷  Start Trial
United Kingdom 1455502 ⤷  Start Trial
Australia 2007240820 Pre-mixed, ready-to-use pharmaceutical compositions ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: April 25, 2026

Market dynamics and financial trajectory for CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

Cardene in 0.86% sodium chloride in plastic container is a hospital-administered, IV formulation of nicardipine. Its market dynamics are driven by inpatient anesthesia and critical-care protocols, formulary access, substitution among IV dihydropyridines and labetalol/nitroprusside strategies, and the economics of low-dose, high-volume distribution. Financial trajectory is typically tied to (1) acute-care prescribing volume, (2) contract pricing and rebate pressure, and (3) supply continuity and label-adjacent competitive intensity.

What is the product and what market does it sit in?

Product: Cardene in 0.86% sodium chloride in plastic container
Drug class: Nicardipine (IV calcium-channel blocker)
Typical use setting: Hospital inpatient, including ICU for blood pressure control (including perioperative and hypertensive emergencies, depending on local protocol and label usage)

Market category: Acute-care IV cardiovascular infusion
Buyer: Hospitals and health systems via group purchasing organizations (GPOs), pharmacy benefit managers (PBMs) for carve-outs (where applicable), and direct contracting
Primary sales channels: Contract pharmacy/hospital procurement, EDI-based institutional purchasing, and GPO-negotiated pricing

How does demand behave in this market?

Demand for IV nicardipine is largely protocol-driven rather than discretionary. It correlates with:

  • Admission and ICU census for surgical and critical-care populations
  • Use of infusion-based BP management rather than bolus-only approaches
  • Hospital formulary design for rapid titration, infusion stability, and nursing familiarity
  • Substitution norms among alternative agents with overlapping indications

Elasticity profile: Moderate to low. Hospitals rarely switch outside of:

  • formulary changes
  • a price and rebate trigger
  • supply disruption
  • adverse-event or stability concerns affecting nursing workflows

What competitive forces shape pricing?

IV nicardipine is exposed to two competitive layers:

1) Same-mechanism substitution

Other IV dihydropyridine options (where available in a market) can displace or split share based on procurement terms and product handling characteristics.

2) Cross-mechanism substitution

Hospitals can also switch to:

  • labetalol (IV beta-blocker strategy)
  • nitroprusside (rapid titratable vasodilator, with distinct monitoring requirements)
  • clevidipine (another IV CCB used for titratable BP control, depending on region and formulary)

Net effect: Pricing power is constrained by contract bidding and the ease of therapy substitution for acute indications.

What pricing and contracting dynamics matter most?

Hospital IV cardiovascular products are usually sold under:

  • GPO contracts with tiered discounts
  • rebate structures tied to annual spend
  • tender processes for acute-care formulary changes
  • allocation rules in supply-constrained periods

Implications for financial trajectory:

  • Revenue growth is most sensitive to formulary placement and annualized patient volume in contract accounts.
  • Margin is sensitive to rebate compression and distribution spend.
  • Volatility increases during supply interruptions because hospitals buy from the “available” alternative, locking out the out-of-stock product until the next contract cycle or clinical re-education period.

How likely is near-term volume expansion?

Near-term volume expansion for IV nicardipine tends to come from:

  • new ICU protocol rollouts
  • conversion of perioperative BP pathways (anesthesia-driven)
  • re-stocking after supply stabilization or previous product unavailability
  • formulary expansions in multi-hospital systems

Near-term volume risks are linked to:

  • tighter ICU medication standardization programs
  • increased preference for a competitor CCB where it is cheaper under contract
  • procurement consolidation and stricter tendering

What does the supply and manufacturing reality imply financially?

For IV infusion products, manufacturing execution and packaging continuity matter because:

  • hospitals require consistent availability to avoid workflow disruption
  • substitutions are slow to reverse after clinical standardization
  • shortages can cause permanent share loss across fiscal quarters, especially where formularies are locked

Financial read-through: Sales trajectory typically follows a step-function pattern when supply problems occur, followed by a slower catch-up as procurement contracts and clinical protocols reset.


Financial trajectory drivers: how revenue and margins move

Revenue drivers (top line)

  1. Contract placement and account penetration
    • Conversion into or out of hospital formularies
    • Expansion from single sites to multi-site system rollouts
  2. Inpatient procedure mix
    • More surgical cases and ICU utilization lift infusion demand
  3. Switching behavior during competitive or supply events
    • Product availability and cost parity drive short-term share shifts
  4. Budget constraints and rebate pressure
    • Buyers trade among equivalent therapies during annual contracting cycles

Margin drivers (profitability)

  1. Net price vs list price compression
    • Rebates and contract discounts reduce realized pricing
  2. Distribution and wholesaler terms
    • Institutional distribution adds layers of cost to margin realization
  3. Manufacturing and packaging cost
    • Plastic container packaging, fill/finish efficiencies, and logistics affect gross margin
  4. Sourcing and compliance costs
    • Regulatory and quality systems cost load impacts cost of goods sold (COGS)

Trajectory expectation: Most mature acute-care IV drugs show low single-digit growth in stable supply years, with step changes during contract cycles and supply disruptions. Sustained share gains are usually required for multi-year outperformance.


Key market dynamics that affect valuation and R&D priority

**1) Formulary status is the principal revenue switch?**

For hospital IV cardiovascular infusions, formulary inclusion drives:

  • predictable procurement volumes
  • repeat ordering cycles
  • lower effective churn versus outpatient products

Financial implication: A product that gains or loses a large system contract experiences revenue movement more rapidly than a product competing primarily through marketing or prescriber outreach.

**2) Competition is “protocol plus contract” not “molecule only”?**

Even when therapies are clinically interchangeable, financial outcomes hinge on:

  • the negotiated price
  • the inclusion tier (preferred vs non-preferred)
  • substitution rules inside the pharmacy and therapeutics committee

Financial implication: A competitor with stronger contract economics can take share without major clinical differentiation.

**3) Shortages cause durable share damage?**

If supply constraints force substitution:

  • nursing and ICU pathways re-learn workflow
  • pharmacy stock behavior shifts
  • decision-makers revert only at the next formulary or protocol update

Financial implication: Post-shortage recovery is often slower than initial loss.

**4) Packaging and handling can be decisive in tendering?**

Plastic container presentation affects:

  • storage and infusion setup workflows
  • compatibility and preparation time in ICU settings

Financial implication: These practical differences can support preferred positioning, which improves net revenue capture.


What is the likely competitive neighborhood for this formulation?

Cardene IV nicardipine in 0.86% sodium chloride is best viewed as one of several institutional-grade, titratable IV BP management tools in acute care.

Primary substitutes hospitals evaluate during contracting and shortages:

  • IV nicardipine alternatives (same class)
  • IV clevidipine (another titratable CCB, where formulary-allowed)
  • IV labetalol (beta-blocker option)
  • IV nitroprusside (vasodilator option)

Competitive edge for Cardene depends on:

  • contract pricing and rebate structure
  • reliability of supply
  • infusion workflow fit for ICU and perioperative departments

Scenario-based financial trajectory (institutional IV pattern)

Base case (stable supply, stable formulary)

  • Revenue: low growth or flat-to-modest expansion driven by inpatient volume and incremental contract renewals
  • Margins: steady but pressured by contracting and rebate compression

Upside case (formulary expansion and preferred contracting)

  • Revenue: outperformance driven by new hospital system placements and increased use per eligible case
  • Margins: moderate improvement if realized net price holds and distribution terms stay favorable

Downside case (rebate pressure, tender loss, or supply disruption)

  • Revenue: step-down around contract cycles or shortage windows
  • Margins: compression from lower net price and higher logistics or compliance costs

This pattern is consistent with institutional IV hospital drugs where prescribing is standardized and switching is procurement- and availability-led.


Investor and R&D action points inferred from the dynamics

Commercial actions with the highest ROI

  • Win or defend preferred formulary status across large hospital systems (multi-site is the lever)
  • Protect supply continuity and allocation behavior to prevent durable share loss
  • Optimize contract economics to maintain realized net price during annual tenders

R&D actions that align to buying behavior

For lifecycle and pipeline planning, priority typically goes to:

  • improved packaging or administration that reduces nursing burden
  • stability or compatibility claims that support protocol adoption
  • differentiation that matters to pharmacy and therapeutics committees

Key Takeaways

  • Cardene in 0.86% sodium chloride in plastic container is an acute-care IV nicardipine product whose revenue trajectory is primarily dictated by hospital formulary status, contract economics, and supply reliability.
  • Market demand tracks ICU and perioperative volume and protocol-driven BP management rather than consumer pull.
  • Pricing and margin are constrained by rebate compression and cross-mechanism substitution (labetalol/nitroprusside/other CCB pathways).
  • Financial outcomes typically follow step-function behavior around contract cycles and supply events, with recovery often slower than initial loss.

FAQs

1) What primarily determines Cardene’s hospital demand?

Hospital protocols for titratable blood pressure control in ICU and perioperative settings, combined with formulary status and continuity of supply.

2) Why is realized net price usually more important than list price for this product?

Because hospital procurement relies on GPO and direct contracts with rebates and discounts that materially change realized pricing.

3) What substitution risks affect share?

Hospitals can switch among other IV titratable therapies, including beta-blocker and vasodilator strategies, and other CCB options where they are preferred under contract.

4) How do supply disruptions change financial performance?

They can cause durable share damage as hospitals standardize on available alternatives and re-establish preferred therapy later only at protocol or contract renewal points.

5) What commercial lever most directly improves revenue?

Securing or retaining preferred placement across large health-system accounts, since inpatient IV utilization is repeat and protocol-led.


References

[1] American Hospital Association. Hospital statistics and utilization reports. (Web pages accessed via AHA publications).
[2] IQVIA Institute. Trends in hospital pharmacy and contract dynamics for acute-care medicines. (Reports and summaries).
[3] FDA. Nicardipine product labeling and pharmacology references for IV use in inpatient settings. (FDA prescribing information database).

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