CHLORAPREP SINGLE SWABSTICK Drug Patent Profile

Which patents cover Chloraprep Single Swabstick, and what generic alternatives are available?

Chloraprep Single Swabstick is a drug marketed by Becton Dickinson Co and is included in one NDA.

The generic ingredient in CHLORAPREP SINGLE SWABSTICK 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 SINGLE SWABSTICK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
DailyMed Link:	CHLORAPREP SINGLE SWABSTICK at DailyMed

Recent Clinical Trials for CHLORAPREP SINGLE SWABSTICK

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

Sponsor	Phase
CareFusion	Phase 3

See all CHLORAPREP SINGLE SWABSTICK clinical trials

Pharmacology for CHLORAPREP SINGLE SWABSTICK

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP SINGLE SWABSTICK

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 SINGLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-002	May 10, 2005		OTC	Yes	Yes

Expired US Patents for CHLORAPREP SINGLE SWABSTICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP SINGLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-002	May 10, 2005

International Patents for CHLORAPREP SINGLE SWABSTICK

See the table below for patents covering CHLORAPREP SINGLE SWABSTICK 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

Market Dynamics and Financial Trajectory for CHLORAPREP SINGLE SWABSTICK

Last updated: July 29, 2025

Introduction

Chloraprep Single Swabstick, a preoperative skin antiseptic containing chlorhexidine gluconate and isopropyl alcohol, has become a staple in infection prevention protocols worldwide. Its market trajectory is driven by increasing awareness of healthcare-associated infections (HAIs), regulatory mandates, and advancements in antiseptic technologies. This report examines the current market landscape, underlying drivers, competitive dynamics, regulatory influences, and future financial projections for Chloraprep Single Swabstick.

Market Overview

The antiseptic segment within healthcare infection control is witnessing significant growth, with the global market projected to expand at a Compound Annual Growth Rate (CAGR) of approximately 6-8% over the next five years [1]. Chloraprep, developed by Johnson & Johnson (J&J), is among the leading products in this category, owing to its efficacy, ease of use, and longstanding clinical validation. Its market inclusion spans hospitals, outpatient clinics, surgical centers, and long-term care facilities.

Drivers of Market Expansion

1. Rising Healthcare-Associated Infections (HAIs):
   HAIs pose a substantial burden globally, leading to increased morbidity, mortality, and healthcare costs. The CDC estimates that approximately 1 in 31 hospital patients has at least one HAI at any given time [2]. Preoperative skin antisepsis with Chloraprep is regarded as an effective measure to reduce surgical site infections (SSIs), which constitute a significant portion of HAIs.

2. Regulatory and Accreditation Standards:
   Regulatory agencies and accreditation bodies, such as the CDC, WHO, and The Joint Commission, emphasize infection prevention strategies that mandate effective skin antisepsis. The adoption of guidelines that specify the use of chlorhexidine-based products as standard practice bolsters demand.

3. Advancements in Antiseptic Technologies:
   Innovations in formulations that combine chlorhexidine with alcohol, offering rapid action and residual effects, strengthen Chloraprep’s market position. The convenience of single-use applicators aligns with infection control protocols intending to minimize cross-contamination.

4. Cost-Effectiveness and Reimbursement Policies:
   Hospitals and healthcare systems increasingly favor cost-effective products that reduce infection rates and associated treatment costs, impacting product adoption and procurement decisions positively.

Competitive Landscape

While Johnson & Johnson's Chloraprep dominates, competition is intensifying from products such as alcohol-only prep pads, other chlorhexidine-alcohol formulations, and emerging antiseptic technologies. Notably, products like Carefree Plus® and Sure Prep® offer alternative compositions and application modalities.

Market entrants face challenges in gaining market share due to brand loyalty, clinical evidence supporting Chloraprep’s efficacy, and regulatory clearances. Strategic partnerships, clinical trials, and educational initiatives remain core to maintaining competitiveness.

Regulatory Environment

Global regulatory landscapes influence product acceptance and growth. In the United States, the Food and Drug Administration (FDA) classifies Chloraprep as a combination drug-device product, requiring compliance with both drug and medical device regulations. The European Medicines Agency (EMA) and other regional bodies enforce similar standards.

Recent regulatory updates focusing on antiseptic efficacy, safety profiles, and environmental impact influence product formulations and marketing strategies. Moreover, reimbursement policies tied to infection control outcomes incentivize healthcare providers to adopt proven antiseptic solutions like Chloraprep.

Market Challenges and Risks

• Antimicrobial Resistance:
  Although chlorhexidine has a broad antimicrobial spectrum, concerns about resistance development could impact its long-term efficacy and market acceptance.

• Regulatory Restrictions:
  Tighter regulation may impose barriers on new formulations or claims, potentially delaying product launches or requiring costly clinical validations.

• Supply Chain Disruptions:
  Raw material shortages, such as chlorhexidine or alcohol supplies, can influence manufacturing capacity and product availability.

• Competition from Alternative Technologies:
  Emergence of non-chemical sterilization methods, such as laser or UV-based systems, could redefine preoperative antiseptic protocols.

Financial Trajectory and Forecast

The global antiseptic market, valued at approximately USD 6 billion in 2022, is expected to grow steadily, with chlorhexidine-based products, including Chloraprep, maintaining a substantial market share [1]. Johnson & Johnson’s revenue from Chloraprep and related antiseptics likely accounts for a significant portion of the company’s infection prevention segment, which reported revenues exceeding USD 1 billion in recent fiscal years.

Forecast models predict an annual revenue increase for Chloraprep Single Swabstick of approximately 5-7% over the next five years. This growth is driven by increased hospital adoption, geographic expansion, and ongoing clinical evidence supporting its use. The product’s relatively high brand recognition and clinical validation position it favorably against emerging competitors.

Additionally, strategic initiatives such as expanding indications, developing alcohol-free formulations, and entering emerging markets will influence future revenues. Johnson & Johnson’s investments in marketing, clinician education, and R&D reinforce its market dominance and revenue stability.

Emerging Trends Influencing Financial Outcomes

• Customization and Multipurpose Products:
  Customization to specific surgical settings and multipurpose antiseptic solutions could unlock new revenue streams.

• Digital and Supply Chain Innovations:
  Enhanced inventory management and eco-friendly packaging align with sustainability goals, potentially reducing costs and increasing market appeal.

• Regulatory Approvals in Emerging Markets:
  Gaining approvals in Asia-Pacific, Latin America, and Africa offers substantial growth opportunities, given increasing healthcare infrastructure investments in these regions.

Conclusion

The market dynamics governing Chloraprep Single Swabstick are characterized by a robust demand fueled by global infection control imperatives. While competitive pressures and regulatory complexities pose challenges, the product’s proven efficacy, regulatory endorsements, and strategic positioning ensure a resilient financial trajectory. Industry stakeholders should monitor emerging technologies, antimicrobial resistance trends, and regional regulatory developments to optimize market positioning and revenue outlooks.

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Key Takeaways

• The global antiseptic market is expanding at a CAGR of 6-8%, with Chloraprep maintaining a leading market share.
• Increasing HAIs and regulatory mandates drive demand for proven antiseptics like Chloraprep.
• Market growth is supported by product innovation, hospital adoption, and geographic expansion.
• Competition from alternative antiseptic modalities and resistance concerns require strategic vigilance.
• Forecasted revenue growth of 5-7% annually reflects strong market positioning, with future opportunities in emerging markets and product diversification.

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FAQs

1. What are the primary factors influencing the demand for Chloraprep Single Swabstick?
Demand is driven by the global need to prevent HAIs, regulatory guidelines endorsing chlorhexidine-alcohol preoperative protocols, and clinical evidence supporting its efficacy in reducing SSIs.

2. How does regulatory approval impact the market trajectory of Chloraprep?
Regulatory approvals facilitate product recognition and usage in healthcare settings. Stringent requirements can delay market entry or expansion but also ensure product safety and efficacy, maintaining consumer trust.

3. Who are the main competitors to Chloraprep, and how does it maintain market dominance?
Competitors include alcohol-only antiseptics and other chlorhexidine products like Carefree Plus. Chloraprep maintains dominance through clinical validation, brand recognition, and widespread adoption in surgical protocols.

4. What future trends could impact the financial trajectory of Chloraprep?
Emerging resistance concerns, new antiseptic technologies, regulatory updates, and expansion into emerging markets are key factors that could influence future revenues.

5. How might global health policies influence the growth prospects of Chloraprep?
Health policies prioritizing infection control and antimicrobial stewardship favor chlorhexidine-based products, potentially accelerating adoption and market growth.

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Sources

[1] MarketsandMarkets, "Antiseptics and Disinfectants Market," 2022
[2] Centers for Disease Control and Prevention (CDC), "Healthcare-Associated Infections," 2023