CHLORAPREP ONE-STEP Drug Patent Profile

When do Chloraprep One-step patents expire, and when can generic versions of Chloraprep One-step launch?

Chloraprep One-step is a drug marketed by Becton Dickinson Co and is included in two NDAs.

The generic ingredient in CHLORAPREP ONE-STEP 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

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	45
What excipients (inactive ingredients) are in CHLORAPREP ONE-STEP?	CHLORAPREP ONE-STEP excipients list
DailyMed Link:	CHLORAPREP ONE-STEP at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CHLORAPREP ONE-STEP

Constraining patent/regulatory exclusivity:

7,422,388

NDA:

020832

Dosage:

SPONGE;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CHLORAPREP ONE-STEP

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

Sponsor	Phase
Yaneve Fonge	Phase 4
Rush University Medical Center	N/A
Gebauer Company	Phase 4

See all CHLORAPREP ONE-STEP clinical trials

Pharmacology for CHLORAPREP ONE-STEP

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP ONE-STEP

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	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-006	Nov 21, 2006		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-008	Oct 23, 2008		OTC	Yes	Yes
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-004	Aug 20, 2003	6,536,975
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000	D396911
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000	5,752,363
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000	5,772,346
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-001	Jul 14, 2000	5,538,353

International Patents for CHLORAPREP ONE-STEP

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

Country	Patent Number	Title	Estimated Expiration
Australia	2002243289
Austria	262323
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)
European Patent Office	1337455	APPLICATEUR DE LIQUIDE DOTE D'AILERONS DIAMETRALEMENT OPPOSES (LIQUID APPLICATOR WITH DIAMETRICALLY OPPOSED WINGS)
Portugal	1581300

Market Dynamics and Financial Trajectory for CHLORAPREP ONE-STEP

Introduction to CHLORAPREP ONE-STEP

CHLORAPREP ONE-STEP is a widely used antiseptic skin preparation product, formulated with 2% chlorhexidine gluconate and 70% isopropyl alcohol. It is designed for pre-operative and pre-injection skin preparation to reduce the risk of surgical site infections.

Market Size and Growth

The global skin antiseptic products market, which includes CHLORAPREP ONE-STEP, is experiencing significant growth. As of 2024, the global skin antiseptic products market size was estimated at USD 3.42 billion and is projected to reach USD 6.50 billion by 2034, growing at a CAGR of 6.64% from 2024 to 2034[1].

Regional Market Dominance

North America currently dominates the global skin antiseptic products market, driven by the increased penetration of healthcare units, a rising number of surgeries, and a growing geriatric population. This region is expected to sustain its dominance during the forecast period. However, the Asia Pacific region is also emerging as a highly opportunistic market due to the rising penetration of hospitals and clinics, increased government expenditure on healthcare infrastructure, and a large population with a high incidence of accidents[1].

Product Efficacy and Safety

CHLORAPREP ONE-STEP has been clinically proven to be highly effective in reducing microbial counts on the skin. Studies have shown that it provides persistent antimicrobial activity, significantly reducing the risk of surgical site infections compared to other antiseptics like 70% isopropyl alcohol or 2% aqueous chlorhexidine alone[3][4].

Regulatory Approvals and Guidelines

The product has received FDA approval for marketing as a patient pre-operative and pre-injection skin preparation. It meets the new recommendations for skin antisepsis published by the Centers for Disease Control and Prevention (CDC), which prefer a 2% chlorhexidine-based antiseptic solution for skin preparation prior to catheter insertion[4].

Financial Ties and Controversies

CHLORAPREP ONE-STEP has been at the center of controversy due to financial ties between its manufacturer, CareFusion, and healthcare quality groups. A U.S. Justice Department case revealed that CareFusion paid $11.6 million to a business run by a key figure in the National Quality Forum, allegedly to influence guidelines in favor of ChloraPrep. This led to questions about the integrity of the guidelines and the potential for commercial influence on healthcare standards[2].

Market Impact of Controversies

Despite the controversies, CHLORAPREP ONE-STEP remains a market-leading product. The allegations of financial ties and potential manipulation of guidelines have not significantly impacted its sales, as it continues to be recommended by healthcare guidelines and widely used in clinical settings. However, these issues highlight the need for transparency in healthcare quality standards and the importance of avoiding conflicts of interest[2].

Consumer and Healthcare Provider Preferences

The rising consumer expenditure on health and wellness, along with the increasing popularity of minimal invasive surgeries, is driving the demand for skin antiseptic products like CHLORAPREP ONE-STEP. Healthcare providers prefer this product due to its efficacy, ease of use, and compliance with CDC guidelines[1].

Competitive Landscape

The skin antiseptic market is competitive, with various products available. However, CHLORAPREP ONE-STEP stands out due to its unique formulation and FDA approval. The product's benefits, such as its non-linting tip, longer shelf-life, and clear, non-sticky application, make it a preferred choice among healthcare professionals[4].

Technological Innovations

The development of innovative products like the ChloraPrep One-Step Sepp applicator has enhanced the market position of CHLORAPREP ONE-STEP. This applicator is designed for hands-off aseptic application to smaller areas, offering convenience and efficiency in clinical settings[4].

Financial Performance

CHLORAPREP ONE-STEP has been a financially successful product. In 2010, it was reported that ChloraPrep generated sales of $193 million, making it the number one drug in its class. The financial performance of the product is expected to continue growing as the demand for skin antiseptic products increases[2].

Key Takeaways

• Market Growth: The global skin antiseptic products market, including CHLORAPREP ONE-STEP, is projected to grow significantly, reaching USD 6.50 billion by 2034.
• Regional Dominance: North America leads the market, but the Asia Pacific region is emerging as a key growth area.
• Product Efficacy: CHLORAPREP ONE-STEP is clinically proven to be highly effective in reducing microbial counts and preventing surgical site infections.
• Regulatory Compliance: The product meets CDC guidelines and has FDA approval.
• Financial Controversies: Despite controversies over financial ties, the product remains a market leader.
• Consumer and Provider Preferences: Rising health and wellness expenditures and the popularity of minimal invasive surgeries drive demand.

FAQs

1. What is the projected market size of the global skin antiseptic products market by 2034? The global skin antiseptic products market is projected to reach around USD 6.50 billion by 2034[1].

2. Which region dominates the global skin antiseptic products market? North America currently dominates the global skin antiseptic products market[1].

3. What are the key ingredients in CHLORAPREP ONE-STEP? CHLORAPREP ONE-STEP contains 2% chlorhexidine gluconate and 70% isopropyl alcohol[4].

4. Has CHLORAPREP ONE-STEP been involved in any financial controversies? Yes, CHLORAPREP ONE-STEP was involved in a controversy related to financial ties between its manufacturer and a healthcare quality group, which led to allegations of potential manipulation of guidelines[2].

5. What are the benefits of using CHLORAPREP ONE-STEP? CHLORAPREP ONE-STEP offers persistent antimicrobial activity, ease of use, and compliance with CDC guidelines. It also features a non-linting tip, longer shelf-life, and clear, non-sticky application[4].

Cited Sources

1. Precedence Research: "Skin Antiseptic Products Market Size to Hit USD 6.50 Bn by 2034"[1]
2. ProPublica: "Hidden Financial Ties Rattle Top Health Quality Group"[2]
3. PubMed: "A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine."[3]
4. Infection Control Today: "FDA Approves ChloraPrep One-Step Sepp Applicator"[4]