Last Updated: May 10, 2026

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Fluconazole In Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Fluconazole In Sodium Chloride 0.9% In Plastic Container launch?

Fluconazole In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Baxter Hlthcare, Dr Reddys, Hikma, Hikma Farmaceutica, Hospira, Inforlife, Mylan Labs Ltd, and Woodward. and is included in nine NDAs.

The generic ingredient in FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is fluconazole. There are twenty-three drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluconazole In Sodium Chloride 0.9% In Plastic Container

A generic version of FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER was approved as fluconazole by CHARTWELL on July 29th, 2004.

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Summary for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Recent Clinical Trials for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

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SponsorPhase
Sunshine Lake Pharma Co., Ltd.PHASE1
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)EARLY_PHASE1
ZonMw: The Netherlands Organisation for Health Research and DevelopmentEARLY_PHASE1

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Pharmacology for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076766-001 Jul 29, 2004 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Woodward FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 077909-001 May 26, 2010 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma Farmaceutica FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078698-001 Jan 30, 2012 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076837-002 Jan 13, 2005 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076617-002 Jul 29, 2004 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma Farmaceutica FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078698-002 Jan 30, 2012 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: April 24, 2026

Market dynamics and financial trajectory for Fluconazole in Sodium Chloride 0.9% in plastic container

Fluconazole in sodium chloride 0.9% for IV administration is a narrow, commodity-like niche within the broader fluconazole market. The financial trajectory is driven less by differentiation and more by (1) whether the product is positioned as a ready-to-use IV formulation versus reconstitution from bulk, (2) payer and hospital formulary dynamics for generic fluconazole, (3) supply reliability and container-cost structure for plastic systems, and (4) competitive pressure from alternative IV antifungals and oral switching when clinically appropriate.

What does the product sit in-market?

“Fluconazole in sodium chloride 0.9% in plastic container” is an IV-delivered, generic-equivalent presentation of fluconazole. It competes inside a class where demand is largely driven by hospital antifungal prescribing and prophylaxis practices, with pricing shaped by generic penetration and group purchasing organization (GPO) contracting.

Key market positioning factors:

  • Generic class economics: Fluconazole is long-off-patent in most geographies, so pricing tends toward low-cost contract pricing rather than premium-to-standard price ladders.
  • Administration route constraint: IV formulations retain demand in settings requiring immediate IV therapy, where patients cannot take oral meds, or where protocols prefer IV dosing for specific diagnoses.
  • Formulation and packaging: The “in sodium chloride 0.9% in plastic container” wording points to a ready-to-administer or standardized container format where hospital pharmacy operational costs (storage, handling, wasting) can influence purchasing decisions.

How do market dynamics shape pricing and volume?

Pricing and volume move together through purchasing cycles in hospitals and integrated delivery networks.

1) Hospital contracting and GPO concentration

  • Contract pricing for injectable generics is typically set through competitive bids, tenders, and annual renewals, with “lowest net cost” often dominating.
  • Rebate structures and bid compliance (on-time fill rate, lot acceptance, and documentation) can affect whether a SKU maintains a formulary listing.

2) Generic substitution and interchange

  • Where clinicians can switch between oral fluconazole and IV fluconazole, volume can shift based on perceived clinical equivalence and local stewardship policies.
  • Pharmacy and therapeutics committees often standardize on formulary fluconazole products, typically selecting the most cost-effective SKU that meets compatibility and workflow requirements.

3) Supply reliability and container constraints

  • IV plastic containers change logistics and can shift costs through freight density, storage, and pharmacy handling.
  • Any disruption in upstream supply (fluconazole API, saline component, container manufacturing) typically produces short-term price spikes and then re-stabilization when supply returns.

4) Competitive substitution inside antifungals

  • In invasive fungal disease pathways, clinicians may select alternative IV agents (for example, echinocandins) depending on severity and risk stratification.
  • That substitution does not eliminate fluconazole demand but can reduce addressable market for IV fluconazole in high-acuity segments.

What is the demand profile for fluconazole IV products?

Demand for fluconazole is anchored to broad indications that generate recurring prescribing in hospitals:

  • Mucosal and systemic fungal infections where fluconazole is guideline-supported.
  • Prophylaxis in high-risk immunocompromised populations.
  • Therapy continuation after IV initiation (if a patient can later transition to oral).

Volume is typically less sensitive to seasonal patterns than to admission rates, bed occupancy, and immunocompromised patient flow.

A practical way to model demand for this exact presentation:

  • Base demand tracks hospital admissions and antifungal prescribing patterns.
  • Switching effects (IV to oral and oral to IV where needed) shape quarter-to-quarter mix.
  • Purchasing cycles shape revenue recognition timing and contract stability.

What is the financial trajectory path for this product?

For an off-patent generic IV formulation, the financial trajectory usually follows a predictable sequence: early market entry and ramp under one or more competitors, then margin compression as the SKU becomes commoditized and bid pressure intensifies, with occasional volatility tied to supply and contract renewal outcomes.

Revenue and margin dynamics

Revenue

  • Volume growth is driven by contract wins, formulary inclusion, and conversion from alternative routes.
  • Volume decline happens if a competitor underbids on contract renewals, if stewardship drives oral conversion, or if supply constraints force missed orders.

Gross margin

  • In generic injectable segments, gross margin is pressured by:
    • Lower list-to-net pricing ratio due to rebates and discounts.
    • Increased cost of goods tied to plastic container procurement and regulatory/compliance overhead.
    • Competitive pricing floors during contract tenders.

Contract bid effects on realized pricing

Realized revenue depends on net pricing after contracting mechanisms. Common dynamics:

  • Bid wins can lift net revenue per unit temporarily even with small price deltas if scale and distribution leverage improve.
  • Bid losses quickly reduce volume because hospitals switch to the awarded SKU across wards and formularies.

Scenario trajectory (how the numbers typically behave)

The exact product-level financials require claim-level and trade sales data by NDC and manufacturer. At the market level, generic injectable injectables show a standard pattern:

Phase Typical market behavior Financial impact
Entry or re-entry Multiple suppliers compete; contracts initially fragment Revenue grows faster than margin
Consolidation Fewer winning SKUs remain after tenders Margin compresses; revenue depends on contract retention
Mature commoditized Price becomes highly elastic; small bid changes move volume Lower volatility in volume, high pressure on unit economics

This is the trajectory investors and strategists typically expect for an IV fluconazole saline plastic-container presentation in a generic setting.


What competitive forces will determine outcomes?

Bidding pressure and SKU rationalization

Many hospital systems consolidate SKUs to reduce stocking complexity. For IV fluconazole, SKU rationalization typically favors:

  • Lowest-cost contracted generics.
  • Reliable fill-rate history.
  • Product stability and clear labeling that reduces pharmacy handling friction.

Substitution pressure from oral and alternatives

Key substitution channels:

  • Oral switching: If patients stabilize, oral fluconazole can replace IV, shrinking incremental IV demand.
  • Class substitution: In severe cases, echinocandin-first pathways can limit IV fluconazole’s share in the highest-acuity cohort.

Supply chain resilience

The main driver of short-term revenue volatility is supply continuity. Container and component availability can cause:

  • Allocation events that push orders into competitor SKUs.
  • Temporary price relief opportunities if supply tightens for fewer manufacturers.

Regulatory and market structure signals that affect strategy

Even for a generic product, regulatory standing affects commercial trajectory:

  • Labeling that matches hospital protocols can support conversion and retention.
  • Manufacturing site compliance determines ability to stay in contract supply pools.

U.S. registration and market visibility occur via FDA product listings:

  • The FDA’s National Drug Code (NDC) directory is the structural anchor for identifying marketed presentations and tracking changes in active listings. [1]

Commercial strategy implications (what will move the financial curve)

For a manufacturer or distributor, financial outcomes for fluconazole in saline plastic containers hinge on operational and commercial levers more than molecule innovation.

What tends to work

  • Contract execution: strong bid strategy and on-time fulfillment.
  • Package and workflow fit: container availability and handling efficiencies.
  • Channel breadth: coverage across major distributors and hospital systems.

What tends to fail

  • Overreliance on list pricing rather than net contract pricing.
  • Manufacturing volatility that breaks continuity during tenders.
  • Weak documentation or label mismatches that create pharmacy formulary friction.

Market metrics to track for trajectory (actionable dashboard)

Track these indicators to forecast whether revenue will trend up or down through contract cycles:

  • Unit volumes by NDC and contract channel (hospital distributor shipments).
  • Realized net price vs. competitor benchmark (bid-aware comparisons).
  • Formulary status changes across top accounts.
  • Fill rate and backorder frequency for the SKU.
  • Substitution mix: IV-to-oral shift and antifungal class mix in formulary utilization.

Key Takeaways

  • Fluconazole in sodium chloride 0.9% in plastic container is a generic IV presentation where financial trajectory is dominated by hospital contracting, generic substitution, and supply reliability rather than clinical differentiation.
  • Revenue rises and falls primarily with GPO and hospital formulary inclusion and the manufacturer’s ability to maintain supply during bid cycles.
  • Margins follow a commoditization pattern: higher volatility in realized unit economics early, then persistent net price compression as the SKU becomes contract-leveraged and volume shifts to the lowest net-cost supplier.
  • The most important drivers of quarter-to-quarter variance are contract renewals, switching to oral where feasible, and antifungal class substitution in higher-acuity cohorts.
  • The practical forecasting approach is NDC-level shipment and realized net price tracking, mapped to formulary and contract status.

FAQs

1) Is the product’s growth driven by new clinical uptake?
No. Growth typically comes from contracting outcomes, conversion from oral alternatives where clinically required, and maintaining supply continuity during tenders.

2) What most affects revenue per unit?
Realized net price set through bids and rebates. Net pricing generally compresses over time as more suppliers compete for the same hospital accounts.

3) Does the plastic container matter commercially?
Yes. Container availability, handling workflow fit in hospital pharmacy, and logistics costs influence tenders and supplier selection.

4) What substitute products can reduce demand?
Oral fluconazole for step-down therapy and other IV antifungals (notably echinocandin regimens) in protocols for higher-risk invasive fungal disease.

5) What is the most reliable leading indicator of trajectory?
Formulary and contract status changes at the hospital system level, visible through shipment trends by NDC alongside fill-rate and backorder behavior.


References

[1] U.S. Food and Drug Administration. (n.d.). NDC Directory. FDA. https://www.accessdata.fda.gov/scripts/cder/ndc/

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