CHLORAPREP TRIPLE SWABSTICK Drug Patent Profile

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

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

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

Summary for CHLORAPREP TRIPLE SWABSTICK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	CHLORAPREP TRIPLE SWABSTICK at DailyMed

Recent Clinical Trials for CHLORAPREP TRIPLE SWABSTICK

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

Sponsor	Phase
CareFusion	Phase 3

See all CHLORAPREP TRIPLE SWABSTICK clinical trials

Pharmacology for CHLORAPREP TRIPLE SWABSTICK

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP TRIPLE 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 TRIPLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-003	Jun 10, 2009		OTC	Yes	Yes

International Patents for CHLORAPREP TRIPLE SWABSTICK

See the table below for patents covering CHLORAPREP TRIPLE SWABSTICK around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2000507478
Spain	2230615
Brazil	9712117

CHLORAPREP TRIPLE SWABSTICK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ChloraPrep Triple Swabstick

Introduction

ChloraPrep Triple Swabstick, a product of Medi-Flex, Inc., is a significant player in the antiseptic skin preparation market. This FDA-approved product contains 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, making it a potent tool in the prevention of nosocomial infections.

Market Need and Demand

The demand for effective antiseptic skin preparations is driven by the need to reduce nosocomial infections, which are a major concern in healthcare settings. Over 200,000 Americans contract these infections annually, resulting in significant healthcare costs and patient morbidity[1].

Regulatory Approval and Compliance

ChloraPrep Triple Swabstick has received FDA approval for use as a patient pre-operative skin preparation and pre-injection preparation. It meets the CDC's recommendations for skin antisepsis, specifically the preference for a 2% chlorhexidine-based antiseptic solution for catheter insertion[1].

Product Efficacy

Studies have shown that ChloraPrep is highly effective in reducing the number of microorganisms on intact skin. It outperforms other disinfection methods, such as two-step processes, in significantly lowering bacterial colony counts post-disinfection[2].

Market Positioning

ChloraPrep is uniquely positioned due to its broad antibacterial spectrum and persistent activity after application. The product's design for hands-off aseptic application, particularly the 0.67 mL Sepp applicator, makes it ideal for smaller prep sites while larger applicators (1.5 mL, 3.0 mL, and 10.5 mL) cater to broader areas[1].

Competitive Advantage

• Unique Formulation: ChloraPrep is the only FDA-approved product with a 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol formulation in the U.S.[1].
• Long-Lasting Efficacy: The product remains effective in killing bacteria for more than 48 hours after a single 30-second application[1].
• Convenient Packaging: The non-linting tip and triple-wall construction of the applicator ensure minimal excess and no mess, along with a longer shelf-life compared to swabsticks or pads[1].

Financial Trajectory

Market Size and Growth

The market for medical and surgical supplies, which includes antiseptic skin preparations, is substantial. For instance, the UT System estimated an annual spend of over $120 million on medical and surgical distribution alone[3].

Revenue Streams

ChloraPrep generates revenue through its various product lines, including the Triple Swabstick, Single Swabstick, and different applicator sizes. The product's widespread adoption in healthcare settings, driven by its efficacy and compliance with CDC guidelines, contributes significantly to its revenue.

Cost Structure

The cost structure for ChloraPrep includes manufacturing, distribution, and regulatory compliance expenses. The unique triple-wall construction and sterile solution in sterile applicators add to the production costs but also enhance the product's value proposition[4].

Pricing Strategy

The pricing of ChloraPrep is competitive within the antiseptic skin preparation market. Given its superior efficacy and compliance with regulatory standards, it may command a premium price compared to other products. However, the pricing must balance between profitability and affordability for healthcare institutions.

Distribution and Supply Chain

ChloraPrep is distributed through various medical supply channels, including major distributors like McKesson. The product's availability in different sizes and formats ensures it can be integrated into various healthcare settings efficiently[5].

Customer Satisfaction and Adoption

High customer satisfaction is driven by the product's effectiveness, ease of use, and compliance with CDC guidelines. Healthcare professionals appreciate the product's ability to reduce nosocomial infections, which enhances patient safety and reduces healthcare costs[1].

Challenges and Opportunities

Regulatory Challenges

ChloraPrep has faced regulatory challenges, such as the need for additional clinical simulation studies to demonstrate efficacy in certain areas like the groin region. However, these challenges have been addressed through appeals and additional data submissions[4].

Market Opportunities

The growing need for effective antiseptic solutions in healthcare settings presents a significant opportunity for ChloraPrep. Expanding into new markets, such as ambulatory care and non-acute settings, could further increase its market share.

Key Takeaways

• Efficacy: ChloraPrep is highly effective in reducing microorganisms on the skin.
• Regulatory Compliance: It meets CDC guidelines and is FDA-approved.
• Market Positioning: Unique formulation and long-lasting efficacy set it apart.
• Financial Trajectory: Strong revenue streams driven by market demand and compliance.
• Distribution: Widely available through major medical supply channels.

FAQs

What is the active ingredient in ChloraPrep Triple Swabstick?

The active ingredients in ChloraPrep Triple Swabstick are 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol[1].

How long does ChloraPrep remain effective after application?

ChloraPrep remains effective in killing bacteria for more than 48 hours after a single 30-second application[1].

What are the different sizes of ChloraPrep applicators available?

ChloraPrep is available in 0.67 mL, 1.5 mL, 3.0 mL, and 10.5 mL applicators[1].

Is ChloraPrep compliant with CDC guidelines?

Yes, ChloraPrep meets the CDC's recommendations for skin antisepsis, specifically the preference for a 2% chlorhexidine-based antiseptic solution for catheter insertion[1].

How does ChloraPrep compare to other skin disinfection methods?

ChloraPrep outperforms other disinfection methods, such as two-step processes, in significantly lowering bacterial colony counts post-disinfection[2].

Sources

1. FDA Approves ChloraPrep One-Step Sepp Applicator - Infection Control Today
2. Alternative methods of blood donor skin disinfection - Professional Education, Blood.ca
3. REQUEST FOR PROPOSAL - UT System - UT System
4. Center for Drug Evaluation and Research - FDA
5. Impregnated Swabstick ChloraPrep™ One-Step 2% / - McKesson - McKesson