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. Four 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:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	45
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
Yaneve Fonge	Phase 4
Rush University Medical Center	N/A
Henry Ford Health System	Phase 4

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	5,690,958

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
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
China	1092529

CHLORAPREP ONE-STEP SEPP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ChloraPrep One-Step SEPP

Introduction

ChloraPrep One-Step SEPP, a product of Medi-Flex, Inc., is a significant player in the antiseptic market, particularly in the healthcare sector. This article delves into the market dynamics and financial trajectory of this product, highlighting its approval, efficacy, market position, and financial implications.

FDA Approval and Regulatory Compliance

ChloraPrep One-Step SEPP was approved by the United States Food and Drug Administration (FDA) in 2002 for use as a patient pre-operative skin preparation and pre-injection preparation. This approval was a milestone, as it marked the introduction of an FDA-approved chlorhexidine skin prep, aligning with CDC guidelines that prefer 2% chlorhexidine-based antiseptic solutions for skin preparation prior to catheter insertion[1].

Efficacy and Clinical Significance

The product contains 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, making it highly effective against a broad spectrum of microorganisms. Studies have shown that ChloraPrep significantly reduces the number of microorganisms on intact skin and maintains its antibacterial activity for more than 48 hours after a single 30-second application[1].

Market Position

ChloraPrep One-Step SEPP holds a unique position in the market due to its compliance with CDC guidelines and its exclusive formulation. It is the only FDA-approved product with this specific formulation, making it a preferred choice for healthcare professionals. The product is available in various applicator sizes, including 0.67 mL SEPP, 1.5 mL FREPP, and larger sizes, catering to different prep site needs[1][3].

Competitive Landscape

In the antiseptic market, ChloraPrep One-Step SEPP competes with other chlorhexidine-based products such as Hibiclens. However, its unique formulation and FDA approval give it a competitive edge. While generic alternatives are available, ChloraPrep's brand reputation and clinical efficacy maintain its market share[5].

Financial Implications

The financial trajectory of ChloraPrep One-Step SEPP is influenced by several factors:

Revenue Generation

Given its widespread use in hospitals and healthcare facilities, ChloraPrep generates significant revenue. The product's effectiveness and compliance with regulatory guidelines ensure a steady demand, contributing to stable and potentially increasing revenue streams.

Cost Savings

By reducing the incidence of nosocomial infections, ChloraPrep helps healthcare facilities save billions of dollars annually. These cost savings can indirectly contribute to the financial health of the product by maintaining or increasing its adoption rate[1].

Market Expansion

The product's availability in various applicator sizes and its use in different clinical settings (e.g., pre-operative and pre-injection preparations) expand its market reach. This versatility can lead to increased sales and revenue growth.

Product Benefits and Innovations

ChloraPrep One-Step SEPP offers several benefits that contribute to its market success:

Unique Applicator Design

The product features a non-linting tip that controls flow, minimizing excess and mess. The triple-wall construction of the ampoule ensures safety and a longer shelf life compared to swabsticks or pads[1].

User-Friendly and Safe

ChloraPrep is clear, non-sticky, and does not stain the skin, making it user-friendly. However, it must be kept out of eyes, ears, and mouth to avoid serious injury[2][3].

Challenges and Risks

Despite its market position, ChloraPrep faces some challenges:

Regulatory Compliance

Continuous compliance with FDA regulations and CDC guidelines is crucial. Any changes in these guidelines could impact the product's market position.

Side Effects and Precautions

While effective, ChloraPrep can cause irritation or chemical burns, especially in premature infants or infants under 2 months of age. This necessitates careful use and monitoring[2][3].

Market Trends and Future Outlook

The demand for effective antiseptic solutions is on the rise due to the increasing focus on infection control in healthcare settings. Here are some trends and outlooks:

Growing Demand for Infection Control Solutions

The need to prevent nosocomial infections, which affect over 200,000 Americans annually, drives the demand for products like ChloraPrep. This trend is expected to continue, supporting the product's financial trajectory[1].

Technological Innovations

Continuous innovations in applicator design and formulation could further enhance the product's efficacy and user experience, potentially increasing its market share.

Key Takeaways

• FDA Approval: ChloraPrep One-Step SEPP was approved by the FDA in 2002 for pre-operative and pre-injection skin preparation.
• Efficacy: The product is highly effective against a broad spectrum of microorganisms and maintains its activity for over 48 hours.
• Market Position: It holds a unique position due to its compliance with CDC guidelines and exclusive formulation.
• Financial Implications: The product generates significant revenue, helps in cost savings by reducing nosocomial infections, and has potential for market expansion.
• Product Benefits: Unique applicator design, user-friendly, and safe usage.
• Challenges: Regulatory compliance, side effects, and precautions.

FAQs

Q: What is the active ingredient in ChloraPrep One-Step SEPP? A: The active ingredients are 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol[1][3].

Q: What are the primary uses of ChloraPrep One-Step SEPP? A: It is used for patient pre-operative skin preparation and pre-injection preparation[1].

Q: How long does ChloraPrep One-Step SEPP maintain its antibacterial activity? A: It maintains its antibacterial activity for more than 48 hours after a single 30-second application[1].

Q: What are the potential side effects of ChloraPrep One-Step SEPP? A: It can cause irritation or chemical burns, especially in premature infants or infants under 2 months of age[2][3].

Q: Is ChloraPrep One-Step SEPP available in different applicator sizes? A: Yes, it is available in various sizes, including 0.67 mL SEPP, 1.5 mL FREPP, and larger sizes[1][3].

Sources

1. FDA Approves ChloraPrep One-Step Sepp Applicator - Infection Control Today
2. ChloraPrep® One-Step - accessdata.fda.gov
3. chlorhexidine gluconate and isopropyl alcohol solution - DailyMed
4. 20-832 ChloraPrep One-Step Antiseptic Statistical Review - accessdata.fda.gov
5. ChloraPrep One-Step Alternatives Compared - Drugs.com