CHLORAPREP ONE-STEP SEPP Drug Patent Profile

Which patents cover Chloraprep One-step Sepp, and when can generic versions of Chloraprep One-step Sepp launch?

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

The generic ingredient in CHLORAPREP ONE-STEP SEPP 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 SEPP

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	46
DailyMed Link:	CHLORAPREP ONE-STEP SEPP at DailyMed

Recent Clinical Trials for CHLORAPREP ONE-STEP SEPP

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 SEPP clinical trials

Pharmacology for CHLORAPREP ONE-STEP SEPP

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP ONE-STEP SEPP

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 SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-001	Oct 7, 2002		OTC	Yes	Yes

Expired US Patents for CHLORAPREP ONE-STEP SEPP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP SEPP	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-001	Oct 7, 2002

International Patents for CHLORAPREP ONE-STEP SEPP

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

Country	Patent Number	Title	Estimated Expiration
Japan	2000507478
European Patent Office	0929296	APPLICATEUR UNI-DOSE DE GLUCONATE DE CHLORHEXADINE (GCH) A DUREE DE CONSERVATION PROLONGEE (UNIT DOSE CHLORHEXADINE GLUCONATE (CHG) APPLICATOR HAVING EXTENDED CHG SHELF LIFE)
China	1231602
Austria	262323
World Intellectual Property Organization (WIPO)	9814178
New Zealand	334273	Unit dose chlorhexadine gluconate (CHG) applicator having extended CHG shelf life
Spain	2230615

Market Dynamics and Financial Trajectory for CHLORAPREP ONE-STEP SEPP

Last updated: July 27, 2025

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Introduction

Chloraprep One-Step SEPP (Single-Use Preoperative Preparation) has emerged as an innovative antiseptic solution primarily used in surgical settings to reduce surgical site infections (SSIs). Its unique formulation, combining chlorhexidine gluconate and isopropyl alcohol, offers rapid antimicrobial action, making it a preferred choice for preoperative skin preparation. Understanding the market dynamics and financial trajectory of this pharmaceutical product requires a detailed examination of its competitive landscape, regulatory environment, adoption trends, and economic factors influencing its growth.

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Market Overview and Demand Drivers

Growing Incidence of Surgical Site Infections

SSIs constitute a significant portion of healthcare-associated infections (HAIs), accounting for approximately 20% of nosocomial infections worldwide [1]. This prevalence drives demand for highly effective skin antiseptics such as CHLORAPREP ONE-STEP SEPP, which has demonstrated superior efficacy in reducing microbial colonization.

Regulatory Endorsement and Guidelines

Leading health entities including the CDC and WHO recommend chlorhexidine-based solutions for preoperative skin disinfection, supporting market expansion [2]. Such endorsements bolster manufacturers’ credibility and facilitate hospital procurement decisions.

Increasing Surgical Procedures and Healthcare Expenditure

Global increases in elective surgeries—orthopedic, cardiovascular, and cosmetic—are contributing to steady demand for preoperative antiseptics. Additionally, rising healthcare expenditure globally fosters investment in infection prevention protocols.

COVID-19 Impact

The pandemic heightened awareness around infection control, accelerating sterilization protocols and antiseptic use in surgical and procedural settings. This trend likely sustains demand for products like CHLORAPREP ONE-STEP SEPP [3].

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Competitive Landscape

Key Players and Market Share

The antiseptic segment is dominated by a few large pharmaceutical companies, notably 3M Healthcare, Zuhal Medical, and a handful of regional players offering chlorhexidine-alcohol solutions [4]. CHLORAPREP ONE-STEP SEPP benefits from its proprietary formulation, regulatory approvals, and proven efficacy, positioning it among leading products.

Product Differentiation

Unique advantages include:

• One-step application reducing preparation time.
• Single-use design lowering cross-contamination risk.
• Rapid bactericidal action that surpasses many competitors.

Pricing Strategies and Reimbursement

Pricing is influenced by procurement contracts, hospital procurement policies, and insurance reimbursements. Hospitals often favor cost-effective yet efficacious products, creating a balance between price and perceived value.

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Regulatory and Patent Environment

Regulatory Approvals

Manufacturers must obtain FDA clearance or approval for use in different markets. Continued compliance ensures market access and competitive edge.

Intellectual Property Rights

Patents on proprietary formulations and delivery systems can inhibit generic competition temporarily. However, patent expirations or challenges may introduce alternatives, impacting market share.

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Market Challenges and Risks

Market Saturation and Competition

High penetration in North American and European markets limits rapid growth. Emerging markets offer significant growth opportunities but face regulatory and infrastructural hurdles.

Price Pressures and Healthcare Budget Constraints

Cost containment efforts may restrict product procurement, especially in resource-limited healthcare systems.

Potential Adverse Events and Resistance

Although rare, adverse skin reactions and microbial resistance concerns can influence clinical acceptance and market penetration.

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Financial Trajectory and Investment Outlook

Revenue Projections

Based on current penetration and growth trends, the global antiseptic market is projected to reach approximately $6.2 billion by 2027, growing at a CAGR of 4.2% from 2022 [5]. CHLORAPREP ONE-STEP SEPP is poised to benefit from this growth, with estimates indicating a compound annual sales increase of 6-8% over the next five years, driven by product innovation and expanding clinical adoption.

Pricing and Volume Growth

As hospitals shift toward rapid, multi-procedure disinfectants, increased consumption volume and strategic pricing will influence revenue. The product's convenience and efficacy could command premium pricing in hospitals emphasizing infection control.

Research & Development Investment

Continued R&D by manufacturers aiming to improve formulation efficacy, reduce skin reactions, or extend shelf life attract investor interest, potentially boosting product valuation.

Market Expansion Strategies

• Global Expansion: Entry into emerging markets through strategic partnerships.
• Product Line Extensions: Development of variant formulations catering to specific procedural needs.
• Educational Campaigns: Increasing awareness about SSI prevention to promote product adoption.

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Future Outlook and Market Opportunities

The confluence of increasing surgical volumes, heightened infection control awareness, and technological innovation positions CHLORAPREP ONE-STEP SEPP favorably for sustained growth.

Emerging trends include:

• Integration with Surgical Workflow: Seamless application systems and disposable kits.
• Collaborations with Healthcare Providers: To promote guidelines aligned with product use.
• Digital and Data-Driven Monitoring: Tools to track antiseptic effectiveness and compliance.

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Conclusion

The market dynamics governing CHLORAPREP ONE-STEP SEPP are primarily influenced by rising surgical procedures, infection prevention guidelines, and technological innovations. Financial trajectories indicate promising growth, supported by increasing demand, strategic market penetration, and ongoing R&D investments. However, challenges remain from pricing pressures, competition, and regulatory hurdles. Manufacturers and investors must consider these factors when strategizing to maximize market share and financial return.

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Key Takeaways

• The global antiseptic market is projected to grow steadily, with CHLORAPREP ONE-STEP SEPP positioned as a key player due to its efficacy and convenience.
• Increasing surgical volume and infection prevention guidelines drive demand, especially in developed healthcare markets.
• Market saturation and competitive pressures necessitate continuous innovation and strategic expansion.
• Ongoing R&D and regional market entry can generate significant revenue opportunities.
• Cost containment and regulatory adherence are critical to sustaining growth in diverse healthcare systems.

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FAQs

1. What distinguishes CHLORAPREP ONE-STEP SEPP from other skin antiseptics?
   Its pre-measured, one-step application with rapid antimicrobial efficacy reduces preparation time and minimizes cross-contamination, enhancing surgical workflows.

2. How does regulatory approval impact the market for CHLORAPREP ONE-STEP SEPP?
   Regulatory approvals such as FDA clearance are essential for market access, influencing product credibility and adoption rates worldwide.

3. What are the key growth regions for CHLORAPREP ONE-STEP SEPP?
   North America and Europe are mature markets, but rapid growth is expected in Asia-Pacific and Latin America due to increasing surgical procedures and evolving healthcare infrastructure.

4. How do pricing strategies affect the product’s market penetration?
   Competitive pricing aligned with hospital budgets and reimbursement policies fosters wider adoption, especially in resource-constrained settings.

5. What future innovations could influence the financial trajectory of CHLORAPREP ONE-STEP SEPP?
   Developing formulations with enhanced skin tolerability, extended shelf life, or integrated delivery systems could drive further sales and extend market dominance.

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References

[1] Magill SS, et al. "Multistate point-prevalence survey of healthcare-associated infections." N Engl J Med. 2014;370(13):1198-1208.
[2] World Health Organization. "Guidelines on Hand Hygiene in Health Care." 2009.
[3] CDC. "Infection Control in the Context of COVID-19." 2020.
[4] Current Market Reports. "Global antiseptic solutions market analysis." 2022.
[5] Grand View Research. "Antiseptic Market Size, Share & Trends Analysis." 2022.