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. Four 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:	1
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	5,690,958

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
Spain	2230615
Brazil	9712117
World Intellectual Property Organization (WIPO)	9814178
Canada	2263158	APPLICATEUR UNI-DOSE DE GLUCONATE DE CHLORHEXADINE (GCH) A DUREE DE CONSERVATION PROLONGEE (UNIT DOSE CHLORHEXADINE GLUCONATE (CHG) APPLICATOR HAVING EXTENDED CHG SHELF LIFE)
Austria	262323

CHLORAPREP SINGLE SWABSTICK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CHLORAPREP SINGLE SWABSTICK

Introduction to CHLORAPREP SINGLE SWABSTICK

CHLORAPREP SINGLE SWABSTICK is a preoperative skin antiseptic solution designed to reduce the risk of surgical site infections (SSIs). It contains 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol, making it highly effective against a broad range of gram-positive and gram-negative bacteria[2][5].

Market Demand and Growth Drivers

Increasing Surgical Procedures

The number of surgical procedures performed in the U.S. and globally is on the rise, which significantly increases the demand for effective preoperative skin preparation solutions. This trend is driven by an aging population, advancements in medical technology, and the need for elective surgeries[4].

Prevention of Surgical Site Infections (SSIs)

SSIs are a major concern in healthcare, accounting for 20% of all hospital-acquired infections. The prevention of SSIs is a critical focus in patient care, and products like CHLORAPREP SINGLE SWABSTICK play a crucial role in reducing these infections. The Centers for Disease Control and Prevention (CDC) estimate that approximately half of SSIs are preventable, highlighting the market potential for effective antiseptic solutions[4].

Competitive Landscape

The market for preoperative skin preparation solutions is competitive, with several products available, including those from brands like Hibiclens, Dyna-Hex, and Prevantics. However, CHLORAPREP SINGLE SWABSTICK stands out due to its unique formulation and patented delivery system, which ensures the solution is not contaminated and the CHG molecule is protected from degradation[1][4].

Product Differentiation

CHLORAPREP SINGLE SWABSTICK offers several unique benefits, including:

• A convenient, single-use, latex-free applicator.
• A patented "wing" design to minimize the risk of compromising aseptic technique.
• Rapid activity against a broad spectrum of bacteria.
• A two-year shelf life from the date of production[1][2].

Financial Performance and Trajectory

Revenue Streams

The revenue for CHLORAPREP SINGLE SWABSTICK is generated through sales to healthcare facilities, hospitals, and medical supply distributors. The product is widely available through major medical supply companies like Henry Schein Medical[2].

Market Share and Growth

While specific financial figures for CHLORAPREP SINGLE SWABSTICK are not publicly disclosed, the product's market share can be inferred from its widespread adoption and the growing demand for preoperative skin antiseptics. The approval to change antiseptic labeling and the continuous innovation in the product line have contributed to its market position[3].

Cost-Effectiveness

CHLORAPREP SINGLE SWABSTICK is not only effective but also cost-efficient. By reducing the incidence of SSIs, it helps in lowering healthcare costs associated with extended hospital stays and additional treatments. For instance, CHG has demonstrated a 50% reduction in catheter-related bloodstream infections compared to povidone iodine, which translates into significant cost savings[2].

Regulatory Environment

FDA Approvals and Guidelines

CHLORAPREP SINGLE SWABSTICK complies with FDA regulations and guidelines for preoperative skin preparation. The FDA has approved various formulations of chlorhexidine gluconate solutions, and CHLORAPREP SINGLE SWABSTICK meets these standards. Regulatory approvals and adherence to guidelines ensure the product's safety and efficacy[5].

Safety and Adverse Reactions

While CHLORAPREP SINGLE SWABSTICK is generally safe, it can cause allergic reactions, irritation, or sensitization in some patients. The product labeling includes warnings and instructions for use to minimize these risks. Adverse events associated with CHG products are rare, occurring in less than 1% of treated subjects[5].

Industry Trends and Innovations

Advancements in Antiseptic Solutions

The industry is continuously evolving with new formulations and delivery systems. For example, the introduction of patented "wing" designs and glass ampules in CHLORAPREP products enhances the aseptic technique and protects the CHG molecule from degradation[1].

Integration with Healthcare Practices

CHLORAPREP SINGLE SWABSTICK is integrated into various healthcare practices through training resources and clinical guidelines. Companies like BD support clinical excellence by providing resources on best practices, clinical innovations, and industry trends, further solidifying the product's market position[1].

Customer and End-User Perspective

Ease of Use and Convenience

Healthcare professionals appreciate the ease of use and convenience of CHLORAPREP SINGLE SWABSTICK. The single-use, hands-off applicators ensure a smooth delivery of the solution, minimizing the risk of contamination and compromising aseptic technique[1].

Patient Safety and Outcomes

Patients benefit from the effective antimicrobial activity of CHLORAPREP SINGLE SWABSTICK, which reduces the risk of SSIs and associated complications. The product's safety profile and minimal adverse reactions make it a preferred choice for preoperative skin preparation[4].

Key Takeaways

• Growing Demand: Increasing surgical procedures drive the demand for effective preoperative skin antiseptics.
• Competitive Advantage: CHLORAPREP SINGLE SWABSTICK's unique formulation and delivery system differentiate it in the market.
• Cost-Effectiveness: Reduces healthcare costs by preventing SSIs.
• Regulatory Compliance: Meets FDA standards and guidelines.
• Safety and Efficacy: Generally safe with minimal adverse reactions and high efficacy against bacteria.

FAQs

1. What are the active ingredients in CHLORAPREP SINGLE SWABSTICK?

CHLORAPREP SINGLE SWABSTICK contains 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol[2][5].

2. How does CHLORAPREP SINGLE SWABSTICK prevent surgical site infections?

It reduces bacteria on the skin through its rapid antimicrobial activity, thereby preventing SSIs[4].

3. Is CHLORAPREP SINGLE SWABSTICK safe for all patients?

While generally safe, it can cause allergic reactions or irritation in some patients. It should be used with care in premature infants or infants under 2 months of age[5].

4. What is the shelf life of CHLORAPREP SINGLE SWABSTICK?

The product has a two-year shelf life from the date of production[1].

5. Can CHLORAPREP SINGLE SWABSTICK be reused?

No, CHLORAPREP SINGLE SWABSTICK is designed for single use only to maintain aseptic technique and prevent contamination[5].

Cited Sources:

1. BD ChloraPrep™ Single Swabstick, 1.75 mL - 260100 - BD.
2. ChloraPrep Prep Swabstick - Henry Schein Medical - Henry Schein Medical.
3. CareFusion Gets Approval to Change Antiseptic Labeling - MPO Magazine.
4. Cross Discipline Team Leader Review - FDA.
5. CHLORAPREP ONE-STEP- chlorhexidine gluconate and isopropyl alcohol solution - DailyMed.