CHLORAPREP ONE-STEP FREPP Drug Patent Profile

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

Chloraprep One-step Frepp is a drug marketed by Becton Dickinson Co and is included in one NDA.

The generic ingredient in CHLORAPREP ONE-STEP FREPP 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.

Summary for CHLORAPREP ONE-STEP FREPP

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	46
DailyMed Link:	CHLORAPREP ONE-STEP FREPP at DailyMed

Recent Clinical Trials for CHLORAPREP ONE-STEP FREPP

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

Sponsor	Phase
University of Washington	NA
Yaneve Fonge	Phase 4
Rush University Medical Center	N/A

See all CHLORAPREP ONE-STEP FREPP clinical trials

Pharmacology for CHLORAPREP ONE-STEP FREPP

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP ONE-STEP FREPP

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 FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002		OTC	Yes	Yes

Expired US Patents for CHLORAPREP ONE-STEP FREPP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	D386849
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	5,538,353
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	D396911
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	5,772,346
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	5,752,363
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	5,690,958

International Patents for CHLORAPREP ONE-STEP FREPP

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004083905
Japan	2006520271
Mexico	9801347	APLICADOR DE LIQUIDO. (LIQUID APPLICATOR.)
Austria	262323
Spain	2159651
Japan	2004515285

Market Dynamics and Financial Trajectory for CHLORAPREP ONE-STEP FREPP

Last updated: July 29, 2025

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Introduction

Chloraprep One-Step FREPP, a preoperative skin preparation solution combining chlorhexidine gluconate with alcohol, has gained rapid traction within surgical settings due to its superior antimicrobial efficacy. As infection control remains a critical priority across healthcare institutions globally, understanding the market dynamics and potential financial trajectories for this drug provides valuable insight for healthcare providers, investors, and manufacturers.

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Market Overview & Growth Drivers

Global Surgical Site Infection (SSI) Prevention Market

The global market for SSI prevention, estimated to reach USD 16.7 billion by 2027[1], positions Chloraprep One-Step FREPP as a key modality. Its adoption is driven by escalating healthcare-associated infection (HAI) burdens and regulatory emphasis on surgical safety.

Shift towards Single-Application Preps

The transition from multi-step prep regimens to single, ready-to-use solutions like Chloraprep aligns with operational efficiencies and enhanced compliance. These factors facilitate widespread acceptance among surgical teams and hospital procurement agencies.

Regulatory Endorsements and Clinical Evidence

Regulatory approvals, notably from the FDA, and a mounting body of clinical evidence demonstrating significant reductions in SSIs, bolster market confidence and adoption. Recently, multiple peer-reviewed studies reinforced chlorhexidine-alcohol preparations' superiority over povidone-iodine alternatives[2].

Healthcare Workforce and Infrastructure

Expanding surgical procedures, especially in emerging markets, and the need to minimize postoperative infections contribute to the market’s upward trajectory. Investments in infection control infrastructure further accelerate demand.

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Market Barriers & Challenges

Pricing and Reimbursement Dynamics

Cost considerations remain pivotal. While Chloraprep One-Step FREPP offers operational savings by reducing prep time, initial per-unit costs may be higher than traditional solutions, potentially affecting widespread adoption in cost-sensitive markets.

Market Saturation and Competitive Landscape

Established antiseptic products and generic equivalents challenge market entry barriers. Major players like 3M and Metrex offer competing formulations, requiring differentiation through efficacy, ease of use, or cost benefits.

Regulatory Variability

Differences in regulatory approvals across regions can delay market penetration, especially in developing countries with less streamlined regulatory pathways.

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Financial Trajectory & Revenue Forecasts

Current Revenue Landscape

Chloraprep’s revenue worldwide exceeds USD 200 million annually[3], primarily driven by institutional procurement contracts. Given its high efficacy, the product commands premium pricing, supporting lucrative margins.

Forecasted Growth Rates

Analysts project a CAGR of approximately 7-9% through 2028, driven by increased surgical volumes, product innovation, and geographic expansion. Emerging markets, including Asia-Pacific and Latin America, are expected to see accelerated growth owing to infrastructure development and rising infection control standards[4].

Influence of Market Penetration Strategies

Partnerships with healthcare chains, direct sales approaches, and targeted marketing to surgeons and infection control committees can amplify revenue streams. Incorporation into bundled infection prevention protocols enhances uptake.

Impact of Regulatory Milestones and Product Innovations

Next-generation formulations, including alcohol-free options or skin-friendly variants, could enhance user adoption and expand indications, fostering incremental revenue growth.

Potential Disruptors

Emerging antiseptics, novel antimicrobial agents, or changes in infection prevention guidelines could alter the market landscape, either constraining or expanding Chloraprep’s financial prospective.

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Strategic Opportunities

• Geographic Expansion: Focused entry into emerging markets with high surgical volumes and infection burden.
• Product Diversification: Development of adjunct formulations that cater to specific patient populations, such as pediatric or immunocompromised cohorts.
• Clinical Research: Generating data that further substantiates efficacy claims and supports expanded indications.
• Partnerships and Collaborations: Engaging with hospital networks for exclusive supply agreements.

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Key Market Trends Influencing Financial Outcomes

• Increasing Surgical Procedures: An annual growth rate of 5-6% in global surgeries fuels the base demand.
• Heightened Infection Control Protocols: Regulatory emphasis prompts healthcare compliance, catalyzing product uptake.
• Technological Innovations: New packaging, faster application, and skin-compatible formulations improve user experience and adherence.

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Regulatory & Reimbursement Outlook

In regions with robust regulatory frameworks, such as the United States and European Union, approval processes favor rapid product adoption once clinical efficacy is validated. Reimbursement policies that cover antiseptic preparations influence hospital procurement decisions, impacting revenue models.

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Conclusion

Chloraprep One-Step FREPP's market dynamics hinge on its clinical benefits, operational efficiencies, and strategic positioning amid competitive and regulatory landscapes. Financially, the drug is poised for steady growth, driven by expanding surgical volumes, institutional adoption, and geographic expansion. However, manufacturers must navigate pricing pressures, regulatory variability, and evolving infection prevention standards to maximize long-term profitability.

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Key Takeaways

• Growing Global Demand: Increasing surgical procedures and infection control standards position Chloraprep as a market leader.
• Strategic Focus Needed: Success relies on targeted geographic expansion, differentiation through product innovation, and strong clinical validation.
• Competitive Landscape: Differentiating through efficacy, ease of use, and cost-effectiveness is crucial amid fierce competition.
• Regulatory & Reimbursement: Proactive engagement with regulators and payers accelerates market penetration and revenue growth.
• Future Opportunities: Continuous innovation and strategic partnerships support a resilient financial trajectory over the coming years.

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FAQs

1. What are the primary factors driving demand for Chloraprep One-Step FREPP?
The main drivers include its proven efficacy in reducing SSIs, operational efficiency in surgical prep, regulatory endorsement, and the global increase in surgical procedures.

2. How does the competitive landscape affect the financial prospects of Chloraprep?
Intense competition from generic antiseptics and alternative formulations requires differentiation through clinical efficacy and cost advantages to sustain market share and profitability.

3. What regions offer the most growth opportunities for Chloraprep?
Emerging markets in Asia-Pacific, Latin America, and Eastern Europe are poised for rapid growth due to infrastructure development, rising surgical volumes, and expanding infection control policies.

4. How can manufacturers maximize revenue from Chloraprep?
Strategies include geographic expansion, product innovation, strengthening clinical data, and establishing exclusive hospital contracts.

5. What challenges could impact the financial trajectory of Chloraprep?
Pricing pressures, regulatory delays, competitive product launches, and shifts in infection prevention guidelines can pose risks to growth prospects.

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References

[1] MarketsandMarkets, "Surgical Site Infection Market," 2021.
[2] Clinical study reports on chlorhexidine-alcohol efficacy, published in the Journal of Hospital Infection.
[3] Company financial disclosures, 2022.
[4] Global Infection Control Market report, Research and Markets, 2022.