Last Updated: June 24, 2026

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Cleocin Phosphate In Dextrose 5% In Plastic Container, and when can generic versions of Cleocin Phosphate In Dextrose 5% In Plastic Container launch?

Cleocin Phosphate In Dextrose 5% In Plastic Container is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Cleocin Phosphate In Dextrose 5% In Plastic Container

A generic version of CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as clindamycin phosphate by HIKMA on April 25th, 1988.

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Recent Clinical Trials for CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

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SponsorPhase
GlaxoSmithKlinePhase 1
Stiefel, a GSK CompanyPhase 1

See all CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CLEOCIN PHOSPHATE IN DEXTROSE 5% 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
Pfizer CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 050639-001 Aug 30, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 050639-002 Aug 30, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER clindamycin phosphate INJECTABLE;INJECTION 050639-003 Apr 10, 1991 DISCN Yes 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
Last updated: June 24, 2026

CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER: Market dynamics and financial trajectory

Executive summary: Cleocin Phosphate in Dextrose 5% in plastic container is a parenteral clindamycin formulation used for inpatient and institutional therapy where clinicians need an IV link to clindamycin. In the near-to-medium term, revenue and volume track largely with hospital antibiotic utilization, generic and alternative IV clindamycin supply, tender pricing, and formulary position. Financial trajectory is constrained by (1) competitive generic entry risk for IV clindamycin phosphate solutions, (2) expected price compression from multiproduct manufacturing and distributor channel competition, and (3) working-capital volatility from seasonal antibiotic demand and inventory turns. The net market outlook depends on whether this specific strength-presentation (D5W in a plastic container) is substituted quickly by other clindamycin IV presentations (different diluents, container types, or concentrations) and whether supply disruptions shift short-term demand toward available SKUs.


What is Cleocin (clindamycin) phosphate in D5W in a plastic container and how is it used commercially?

Featured snippet answer: This product is an IV clindamycin phosphate solution supplied premixed in Dextrose 5% (D5W) in a plastic container for hospital/clinic administration, typically used for serious bacterial infections where clindamycin is indicated.

Clinical use patterns that drive institutional demand

Key commercial demand drivers are not “disease prevalence” alone but guideline-based antibiotic selection, local antibiogram patterns, and stewardship restrictions.

  • Target settings: acute care hospitals, surgical centers, emergency departments that stock IV antibiotics in formulary
  • Administration profile: IV therapy where rapid initiation matters (ED to inpatient conversion, perioperative infection management)
  • Stewardship sensitivity: clindamycin use can be tightened when local resistance patterns or C. difficile risk stewardship drives restrictions

How dosing and package format affect procurement

Institutional buyers purchase by:

  • Case needs (dose volume): premixed solutions reduce nursing prep time versus reconstitution from vials
  • Compatibility and workflow: premix in D5W can align with existing IV fluid standardization
  • Container logistics: plastic container preference is often driven by handling, leak resistance, and storage constraints

“Product definition risk” in the channel

“Cleocin phosphate in D5W in plastic container” behaves like a presentation-specific SKU. Buyers can substitute:

  • clindamycin phosphate premix in different diluents (or NS)
  • other strengths and container types (e.g., glass vs plastic)
  • compounded or reconstituted clindamycin when pricing is favorable

How big is the revenue opportunity for IV clindamycin solutions in US hospitals?

Featured snippet answer: The revenue opportunity is typically concentrated in institutional channels and tends to be moderate per SKU, with meaningful total market value driven by national hospital contracting, tender cycles, and multi-supplier competition across multiple clindamycin IV presentations.

Why total market size underestimates SKU revenue

Even when the broader clindamycin IV category is stable, SKU revenue can swing based on:

  • which SKU wins hospital contracts
  • whether procurement prefers a specific diluent or container type
  • whether shortages shift demand to available SKUs

Contracting dynamics matter more than retail

Retail demand for clindamycin IV is usually limited. Commercial trajectory is tied to:

  • GPO formularies and bids
  • IDNs (integrated delivery networks) standardization
  • tender-based pricing that resets frequently

What market dynamics most influence price, volume, and profitability for this exact presentation?

Featured snippet answer: The biggest levers are supply competitiveness among generic IV clindamycin phosphate presentations, channel substitution across diluent and container formats, and contracting pressure that forces margin compression.

1) Generic competition and substitution pressure

IV clindamycin phosphate solutions typically face pricing pressure once generics are broadly stocked and tendered. For this SKU, substitution risk is elevated because:

  • clinicians can switch to equivalent clindamycin phosphate concentrations
  • pharmacists can interchange diluent and container type when compatible and within hospital policy

Implication for trajectory: volume can remain stable in aggregate clindamycin IV use, but the specific D5W-plastic SKU may lose share to cheaper alternatives.

2) Hospital procurement is SKU-specific but contract-ready

Hospital purchasing teams tend to:

  • select “formulary equals” within an antibiogram-driven framework
  • lock in procurement SKUs via bid
  • switch faster during renegotiations if price deltas justify change

Implication: revenue growth is hard without contract wins; revenue declines can be rapid after tender resets.

3) Supply continuity drives short-term demand shifts

Drug shortages or constrained manufacturing can temporarily concentrate orders into available SKUs. When supply stabilizes, orders normalize, often reversing the short-term revenue bump.

Implication: financial trajectory may show step-changes around supply events.

4) Stewardship pressure affects clindamycin exposure

Stewardship interventions, especially around C. difficile risk, can cap clindamycin usage in some institutions.

Implication: category-level volume growth can lag despite clinical need, and SKU-level volume is sensitive to formulary restrictions.


How does this product’s financial trajectory typically evolve across product life-cycle stages?

Featured snippet answer: Trajectory usually follows a pattern: launch premium (if branded and protected), then sustained price compression after generic penetration, then “flattened volume with declining ASP” as contracts mature, with occasional short-lived spikes from supply constraints.

Typical phases for IV antibiotic presentations

  1. Branded/near-exclusive phase
    • higher realized price via formulary status
    • stable ordering in IDN standardization
  2. Generic entry and bid resets
    • sharp ASP decline
    • share shift to lowest-cost interchangeable SKUs
  3. Mature competitive phase
    • volume stability depends on contract award and supply reliability
    • profit increasingly driven by logistics and manufacturing cost position
  4. Disruption normalization
    • temporary upside during shortages
    • downside after resupply increases buyer switching

What determines whether this SKU beats or tracks category

  • manufacturing reliability and fill-finish capacity
  • inclusion in hospital standard kits or “preferred IV fluids” workflows
  • presence/absence of hard-to-source constraints in competing clindamycin IV formats

What do “tender economics” imply for margin and cash flow?

Featured snippet answer: In hospital channels, profitability is typically constrained because contract pricing drives ASP down while working capital depends on forecast accuracy and inventory turns.

Revenue mechanics

  • ASP decline: follows generic penetration and contract renegotiations
  • Rebates/chargebacks: inflate complexity and can move net realized price materially
  • Mix effects: shifts between container formats and strengths impact net revenue per administration

Working capital and inventory turns

  • antibiotics often require tight inventory planning due to shelf-life and batch release timing
  • D5W premix SKUs increase warehousing complexity because fluid products can carry specific storage and handling requirements

Net cash flow sensitivity

Financial trajectory is usually more sensitive to:

  • missed tender wins (volume drop)
  • supply interruptions (inventory depletion and lost sales)
  • chargeback/rebate disputes tied to channel mix

How does FDA status and labeling affect commercial access for this SKU?

Featured snippet answer: FDA-approved labeling and route-specific indications govern substitution and contracting; if therapeutic equivalence is clear across competitors, price competition dominates.

Label-driven use

Commercial uptake follows:

  • IV route indication match for hospital protocols
  • listed indications that align with stewardship standards and local guidelines
  • clarity of dosing/concentration and administration guidance

Product form factor and substitution

Even with therapeutic equivalence, buyer substitution can depend on:

  • container type and pump compatibility
  • infusion compatibility policies
  • perceived nursing workflow benefits of premixed D5W solution

What patent landscape and exclusivity constraints matter for the financial outlook?

Featured snippet answer: For a mature IV clindamycin formulation, the financial outcome is often driven more by generics and product availability than by active branded exclusivity at the SKU level.

Why patent estate specifics drive risk for the exact premix

For a presentation like “phosphate in D5W in plastic container,” patent-driven outcomes can hinge on:

  • formulation or premix composition claims
  • container/packaging claims
  • method-of-use claims that restrict certain dosing regimens

Practical commercial impact of patent status

  • If exclusivity is largely exhausted, revenue is exposed to rapid contracting-based price pressure.
  • If residual narrow patents exist, they can delay some competitors or restrict particular presentation variants, creating temporary niche economics.

How many competitive equivalents exist and which ones are likely to replace this SKU?

Featured snippet answer: Competitive equivalents typically include multiple generic IV clindamycin phosphate premixes across strengths, diluents, and container types; the most likely replacements are the lowest-cost contract winners with reliable supply.

Replacement routes buyers commonly use

  • equivalent clindamycin phosphate strength but different diluent (NS vs D5W)
  • equivalent concentration but different container (plastic vs glass) or packaging
  • alternative suppliers of the same presentation if available at a better net price

What “wins” in the hospital

  • lowest net cost under GPO and IDN contracts
  • reliable lead times and fewer stockouts
  • pharmacy preference for ease of preparation and administration

What is the Orange Book status of this product, and how does it affect generic launch risk?

Featured snippet answer: Orange Book listings for clindamycin phosphate IV products typically show multiple approvals and legal statuses across strengths and dosage forms; generic launch risk is usually high for older, off-patent presentations unless formulation- or packaging-specific protections remain.

How legal status translates into commercial risk

  • if Orange Book lists show no active exclusivity/patents for this exact presentation, tender competition accelerates price compression
  • if patents exist but are narrow to a container or premix formulation, generic penetration may still occur via alternate presentations

What patent litigation or Paragraph IV challenges affect this SKU’s availability and price?

Featured snippet answer: For widely marketed clindamycin IV products, litigation history tends to determine timing and availability of certain generic presentations; however, in mature categories, pricing is dominated by contracting rather than ongoing disputes.

Litigation effects that can move financials

  • delayed entry keeps branded or higher-cost SKU demand elevated
  • successful challenges increase supply and drive ASP down
  • settlements can create time-limited exclusivity windows for specific competitors

How does this SKU compare with other clindamycin IV products in the same formulary?

Featured snippet answer: In practice, the SKU competes against other IV clindamycin phosphate presentations; financial trajectory depends on relative net cost, supply continuity, and ease-of-use in hospital workflows.

Comparative levers

  • diluent (D5W vs NS)
  • container type and size
  • concentration and dosing convenience
  • supplier reliability and lead time
  • contract inclusion and pharmacy standardization

Typical outcome in tenders

Even when clinical equivalence holds, the procurement economics usually choose:

  • the lowest net cost SKU that meets operational requirements
  • the supplier with the best supply-risk profile

What geographic and channel exposure shape demand stability?

Featured snippet answer: Demand stability is driven by the US hospital contracting cycle and domestic manufacturing reliability; cross-border demand is usually secondary for IV hospital antibiotics.

Channel exposure

  • Primary: US acute care hospitals, IDNs, outpatient infusion centers with IV antibiotic protocols
  • Secondary: select clinics and specialty care settings

Demand volatility sources

  • regional formulary updates
  • supply constraints by domestic manufacturers
  • shifts in stewardship guidance that vary by region

Key takeaways on market dynamics and financial trajectory

  1. Revenue is contract-driven. This presentation’s financial trajectory tracks hospital formulary wins and tender outcomes more than broader clindamycin prevalence.
  2. ASP compression is the baseline. Generic equivalents and substitution across IV presentations typically drive sustained net price declines after competitive entry.
  3. SKU-level share is fragile. D5W and plastic container specifics create operational preferences, but buyers can switch quickly to lower-cost substitutes that meet infusion compatibility.
  4. Supply disruptions can cause temporary upside. Short-term spikes occur when certain equivalent presentations are constrained; normalization typically reverses the effect.
  5. Stewardship can cap usage. C. difficile risk management and guideline adherence can reduce clindamycin IV exposure at institutions, affecting volume.

FAQs

  1. How quickly can hospitals substitute clindamycin phosphate D5W plastic solutions with other diluent or container equivalents after a tender price change?
  2. What procurement criteria most influence realized net price for IV antibiotics: GPO pricing, rebate/chargeback structure, or supply-risk lead time?
  3. Which operational factors (premix workflow, pump compatibility, infusion time) most affect pharmacy preference for D5W premixed clindamycin products?
  4. How do antibiotic stewardship programs and local C. difficile risk policies typically affect clindamycin IV utilization by hospital service line?
  5. What supply and manufacturing constraints most commonly shift demand among equivalent clindamycin IV presentations in the US?

References (APA)

  1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
  2. Centers for Disease Control and Prevention. Antimicrobial use and stewardship guidance (programmatic resources).
  3. FDA Drug Shortages. Drug shortage listings for IV antibiotic products (site resources).

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