Last Updated: May 10, 2026

CHLORAPREP ONE-STEP Drug Patent Profile


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When do Chloraprep One-step patents expire, and when can generic versions of Chloraprep One-step launch?

Chloraprep One-step is a drug marketed by Becton Dickinson Co and is included in two NDAs.

The generic ingredient in CHLORAPREP ONE-STEP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

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Questions you can ask:
  • What is the 5 year forecast for CHLORAPREP ONE-STEP?
  • What are the global sales for CHLORAPREP ONE-STEP?
  • What is Average Wholesale Price for CHLORAPREP ONE-STEP?
Summary for CHLORAPREP ONE-STEP
US Patents:0
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 46
What excipients (inactive ingredients) are in CHLORAPREP ONE-STEP?CHLORAPREP ONE-STEP excipients list
DailyMed Link:CHLORAPREP ONE-STEP at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CHLORAPREP ONE-STEP
Generic Entry Date for CHLORAPREP ONE-STEP*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SPONGE;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHLORAPREP ONE-STEP

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

SponsorPhase
University of WashingtonNA
Yaneve FongePhase 4
Rush University Medical CenterN/A

See all CHLORAPREP ONE-STEP clinical trials

Pharmacology for CHLORAPREP ONE-STEP
Physiological EffectDecreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP ONE-STEP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Becton Dickinson Co CHLORAPREP ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-001 Jul 14, 2000 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson Co CHLORAPREP ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-008 Oct 23, 2008 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson Co CHLORAPREP ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-004 Aug 20, 2003 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson Co CHLORAPREP ONE-STEP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-006 Nov 21, 2006 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson Co CHLORAPREP ONE-STEP SEPP chlorhexidine gluconate; isopropyl alcohol SWAB;TOPICAL 021555-001 Oct 7, 2002 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Becton Dickinson Co CHLORAPREP ONE-STEP FREPP chlorhexidine gluconate; isopropyl alcohol SPONGE;TOPICAL 020832-003 Apr 26, 2002 OTC Yes Yes ⤷  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

Expired US Patents for CHLORAPREP ONE-STEP

International Patents for CHLORAPREP ONE-STEP

See the table below for patents covering CHLORAPREP ONE-STEP around the world.

Country Patent Number Title Estimated Expiration
Japan 4435478 ⤷  Start Trial
Japan 3786963 ⤷  Start Trial
China 1231602 ⤷  Start Trial
Germany 69728280 ⤷  Start Trial
Austria 416002 ⤷  Start Trial
Mexico PA05009881 APLICADOR DE LIQUIDO PARA COLOREAR UN LIQUIDO. (LIQUID APPLICATOR FOR COLORING A LIQUID.) ⤷  Start Trial
Spain 2318196 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Chloraprep One-Step: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is Chloraprep One-Step and where does it sell?

Chloraprep One-Step is a chlorhexidine gluconate (CHG) surgical skin antiseptic product used to reduce surgical site infections (SSIs). Commercially, it functions in the perioperative antisepsis segment alongside iodine-based preps and other CHG formats.

Core market geography (US-centric):

  • Product uptake and reimbursement dynamics for perioperative antiseptics are most consistently visible in the US acute-care market (hospital purchasing, formulary inclusion, and bundled surgical procurement).
  • Expansion is typically driven by hospital conversion to standardized skin antisepsis protocols, procurement scale, and infection-prevention initiatives.

Primary customer structure:

  • Hospitals and health systems via group purchasing organizations (GPOs), direct purchasing, and IDN contracts.
  • Surgical centers (ambulatory) as a secondary channel where conversion hinges on protocol adherence and staff workflow.

How do competitive dynamics shape pricing and share?

Chloraprep One-Step competes in a constrained but defensible niche: single-step, ready-to-use surgical prep formats that reduce procedure variability.

Competitive forces that matter most

Force Market impact on Chloraprep One-Step What it means for revenue
Protocol standardization (infection control) Products with strong institutional evidence and clinician adoption win recurring contracts Refill and repeat purchasing; lower volatility
Switch friction (procurement + training) Conversions require formulary and staff workflow changes Slower share gains; stickier installed base
Product format and workflow One-step systems reduce time and handling steps vs multi-step preps Better performance narratives for infection-control committees
Generics and private label CHG preps CHG is a mature antiseptic active; pricing pressure is real where equivalents are accepted Margin compression risk, especially in competitive bid environments
Buyer leverage via GPOs Tends to shift net pricing lower over time Net sales growth depends on volume and contract retention

Competitive positioning (practical)

  • Chloraprep’s market advantage is format and adoption within SSI reduction protocols rather than a high-frequency “drug-like” innovation curve.
  • Growth typically tracks hospital purchasing penetration and replacement cycles, not pipeline-driven demand surges.

What do the market dynamics imply for growth drivers?

For surgical antiseptics like Chloraprep One-Step, the demand model is dominated by:

Volume drivers

  • Case volume growth in inpatient and outpatient surgeries.
  • Market penetration among hospitals converting to CHG-based skin antisepsis protocols.
  • Formulary retention and contract renewals through infection-prevention committees.

Revenue drivers

  • Net price after rebates, GPO fees, and contract structure.
  • Mix shifts toward higher-convenience formats (single-step readiness reduces operational friction).
  • Usage per procedure (higher utilization when clinicians accept the prep as default standard).

Key sensitivity

  • Switching behavior: Once a facility standardizes, share typically becomes stable unless procurement forces a re-bid.
  • Competitive bid outcomes: Net pricing can compress in bid cycles even if unit demand remains intact.

How has the financial trajectory typically evolved for products like this?

A chlorhexidine prep product’s financial trajectory tends to follow a mature-medical-product pattern:

  1. Early growth from formulary adoption and contracting.
  2. Plateau as penetration saturates.
  3. Margin and price discipline issues driven by competitive bids and equivalency arguments.
  4. Continued revenue through replacement demand and protocol reinforcement.

Without company-specific segment disclosures and audited financials for Chloraprep One-Step specifically, a precise timeline of revenue, gross margin, operating margin, and year-over-year growth cannot be stated.

What financial metrics are decision-relevant for this asset class?

For R&D or investment work, the decision-grade metrics for perioperative antiseptics are:

Contract and pricing mechanics (most predictive)

  • Net price trajectory: list price vs realized net after rebates and contract terms.
  • GPO contract renewal outcomes: whether the product retains status or is downgraded to “preferred alternatives.”
  • Volume per account: procedural throughput multiplied by product conversion rate.

Unit economics

  • COGS pressure: packaging, supply chain costs, and competitive manufacturing footprints.
  • Gross margin sensitivity to CHG equivalence: if substitutes are accepted clinically, unit pricing declines faster than unit volumes can offset.

Market share indicators

  • Facility penetration rate: proportion of hospitals in-scope using CHG one-step prep.
  • Order frequency: stable monthly ordering indicates installed base; step-changes indicate contract conversions.

What does the regulatory and guideline environment do to demand?

Surgical antiseptics sit inside a clinical framework where adoption is protocol-driven.

Demand stability is supported by:

  • Infection-control initiatives that continue to prioritize SSI reduction.
  • Guideline-aligned procurement that rewards products with straightforward workflow and consistent application.

In practice, guideline reinforcement tends to:

  • Increase adoption in facilities that are already CHG-leaning.
  • Limit substitution once a facility standardizes.
  • Create predictable but not exponential growth once broad adoption is reached.

How does patent/Exclusivity status typically affect market dynamics here?

For antiseptic products with mature actives like CHG, market dynamics often shift toward:

  • Competitive inroads from equivalent CHG products when exclusivity windows close.
  • Commercial differentiation relying on format and compliance rather than active ingredient novelty.

That translates into:

  • Reduced pricing power over time.
  • Increased importance of contracting execution and institutional evidence.

Is growth likely to accelerate or decelerate?

Acceleration risk is lower for mature surgical antiseptics; deceleration risk is higher due to:

  • Bid-cycle price compression.
  • Perceived clinical equivalence of alternative CHG formats.

Sustainable growth is more likely when:

  • The product keeps preferred status in large accounts.
  • Mix continues shifting toward one-step usage where clinicians reduce workflow variance.

How to map Chloraprep One-Step onto a financial trajectory scenario model

Below is the scenario structure used for products with contract-based demand and mature actives.

Scenario Expected unit trend Expected net price trend Net sales direction Margin direction
Base case (installed base + slow penetration) Steady Gradual decline or stable Low-to-moderate growth Stable to slightly down
Downside (rebids + substitution) Flat to down Clear decline Flat to negative Down meaningfully
Upside (reformulary conversion + mix shift) Up Stable to slight down Moderate growth Stable to slightly up

For decision-making, the key hinge is whether new conversions offset pricing pressure at the same time.

What practical signals indicate which scenario is playing out?

Decision-grade indicators:

  • Account retention: whether top IDNs maintain preferred status.
  • GPO bidding behavior: whether competing CHG products displace Chloraprep.
  • Utilization consistency: stable ordering suggests protocol stickiness.
  • Portfolio mix: any shift toward alternative prep formats from the same company can mask declines in Chloraprep-specific volumes.

Key Takeaways

  • Chloraprep One-Step is a perioperative antiseptic in a protocol-driven market where demand stability comes from hospital infection-prevention standards and repeat purchasing.
  • Competitive dynamics center on CHG equivalence, format convenience, and GPO contracting leverage, which typically compress net pricing over time.
  • The financial trajectory for products like this usually follows mature patterns: early adoption-driven growth, then penetration and contract renewals sustaining revenue while margins face pressure from bids and substitutes.
  • The decisive financial variables are net pricing (after contract mechanics), volume growth via facility penetration, and installed-base retention in major accounts.

FAQs

1) What drives demand for Chloraprep One-Step in hospitals?

Demand is driven by surgical case volume and infection-prevention protocol adoption (CHG-based skin antisepsis), with repeat ordering tied to formulary retention and standard workflow usage.

2) Why can net price decline even if unit volumes stay stable?

Because GPO contracts, rebates, and bid cycles determine realized net pricing, and substitute CHG preps can pressure the contract price even when facilities keep buying the product.

3) How does the “one-step” format affect market performance?

One-step formats reduce handling variability and procedural friction, which can support formulary preference and higher adoption within standardized surgical pathways.

4) What is the biggest financial risk for this asset class?

Price compression from equivalent CHG products and loss of preferred status during rebids, which can lower gross margin even if volumes hold.

5) What market signals should investors track most closely?

Preferred contract retention in major accounts, GPO bidding outcomes, facility penetration/usage rates, and the realized net price trend versus list price.


References

[1] American Society of Health-System Pharmacists (ASHP). Guidelines and clinical practice resources on surgical site infection prevention and antiseptic use.
[2] Centers for Disease Control and Prevention (CDC). Guideline for Prevention of Surgical Site Infection and infection control recommendations relevant to perioperative skin antisepsis.
[3] U.S. Food and Drug Administration (FDA). Product labeling and regulatory information for chlorhexidine-based surgical skin antiseptics.

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