CHLORAPREP WITH TINT Drug Patent Profile

Which patents cover Chloraprep With Tint, and when can generic versions of Chloraprep With Tint launch?

Chloraprep With Tint is a drug marketed by Becton Dickinson Co and is included in one NDA. There is one patent protecting this drug.

This drug has ten patent family members in eight countries.

The generic ingredient in CHLORAPREP WITH TINT 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.

DrugPatentWatch^® Generic Entry Outlook for Chloraprep With Tint

Indicators of Generic Entry

Summary for CHLORAPREP WITH TINT

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	46
DailyMed Link:	CHLORAPREP WITH TINT at DailyMed

Recent Clinical Trials for CHLORAPREP WITH TINT

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

Sponsor	Phase
University of Washington	NA
Yaneve Fonge	Phase 4
Rush University Medical Center	N/A

See all CHLORAPREP WITH TINT clinical trials

Pharmacology for CHLORAPREP WITH TINT

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for CHLORAPREP WITH TINT

CHLORAPREP WITH TINT is protected by one US patents.

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 WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005		OTC	Yes	Yes	7,422,388		Y
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006		OTC	Yes	Yes	7,422,388		Y
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006		OTC	Yes	Yes	7,422,388		Y

Expired US Patents for CHLORAPREP WITH TINT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006	6,536,975
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006	6,991,393
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006	5,690,958

International Patents for CHLORAPREP WITH TINT

See the table below for patents covering CHLORAPREP WITH TINT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004083905
Japan	2006520271
Mexico	9801347	APLICADOR DE LIQUIDO. (LIQUID APPLICATOR.)

Market Dynamics and Financial Trajectory for Chloraprep with Tint

Last updated: July 28, 2025

Introduction

Chloraprep with TINT (Chlorhexidine Gluconate 2% with Isopropyl Alcohol 70% in a Tinted Solution) has established itself as a critical antiseptic in preoperative skin preparation. Its efficacy, safety profile, and ease of use have driven widespread adoption across healthcare settings globally. This analysis explores the market dynamics influencing Chloraprep with TINT, the financial trajectory of its key stakeholders, and anticipated trends shaping its future.

Market Overview

Product Profile and Clinical Significance

Chloraprep with TINT combines chlorhexidine gluconate and isopropyl alcohol, providing broad-spectrum antimicrobial activity. The tinted formulation enhances cosmetic appeal, ensures uniform application, and reduces the risk of incomplete skin coverage—factors pivotal in sterile environments [1].

The product's stature in surgical prep is underpinned by evidence demonstrating superior efficacy in reducing surgical site infections (SSI), a leading cause of postoperative complications. The U.S. CDC emphasizes chlorhexidine-based products for SSI prevention, fueling demand [2].

Market Size and Growth Drivers

The global preoperative skin antiseptics market was valued at approximately USD 1.15 billion in 2022, with a projection to grow at a compound annual growth rate (CAGR) of 5.2% through 2030 [3]. Chloraprep with TINT holds a significant share due to its proven clinical benefits and widespread acceptance.

Key growth drivers include:

• Escalating surgical procedures globally, especially in emerging markets.
• Increasing prevalence of healthcare-associated infections (HAIs) prompting stricter sterilization protocols.
• Rising awareness among healthcare providers about the benefits of chlorhexidine-based antiseptics.
• Innovations in formulation, including tinted variants, enhancing safety and compliance.

Competitive Landscape

Major players include 3M, Mölnlycke Health Care, and UK-based Stryker, with 3M’s Chloraprep leading market share. Patent protections and regulatory approvals create high entry barriers, consolidating market power among established manufacturers [4].

Emerging regional manufacturers are attempting to capture market share via lower-cost alternatives, but clinical efficacy and regulatory compliance remain pivotal differentiators.

Market Dynamics

Regulatory Environment

Regulation significantly influences market access and product lifecycle. Chloraprep with TINT is FDA-approved in the U.S. and has CE marking in Europe. Changes in sterilization standards, antiseptic guidelines, or patent law can shift market balances [5].

Recent regulatory scrutiny over alcohol-based antiseptics, focusing on safety and efficacy, may impact manufacturing and marketing strategies. Nonetheless, the product remains well-positioned due to robust clinical data backing its use.

Technological Advancements

Innovations in formulation technology, including sustained-release formulations and antimicrobial coatings, are under development. Similar products with improved safety profiles or reduced application time could threaten existing market leaders.

The tinted aspect of Chloraprep, while adding value, must withstand scrutiny concerning staining effects and patient safety. Continued R&D aims to enhance user experience and compliance.

Cost and Reimbursement Policies

Healthcare reimbursement policies influence purchasing decisions. In regions where antiseptic products are reimbursable or mandated, market growth accelerates. Conversely, cost containment pressures, especially in developing countries, drive demand for cost-effective alternatives.

Pricing strategies are crucial; premium pricing often correlates with demonstrated clinical superiority, while price competition emerges in cost-sensitive markets.

Supply Chain and Distribution

Reliable supply chains ensure consistent product availability, critical in hospital procurement. The COVID-19 pandemic exposed vulnerabilities, prompting manufacturers to diversify supply sources and inventory buffers.

Distribution channels include direct sales to hospitals, partnerships with medical distributors, and procurement agencies. Strategic alliances facilitate market penetration.

Financial Trajectory

Revenue Streams

Revenue streams for Chloraprep with TINT stem from:

• Direct sales to healthcare facilities
• Government tenders and procurement contracts
• Private healthcare institutions and outpatient clinics

The product’s high efficacy translates to steady demand in surgical, ICU, and outpatient settings.

Profitability and Market Penetration

Leading manufacturers report gross margins between 60-70%, benefiting from brand recognition, regulatory barriers, and product differentiation [6]. Market penetration is highest in North America and Europe, with expanding adoption in Asia-Pacific driven by increasing surgical volumes.

Investment and R&D Spending

Major companies allocate substantial R&D budgets (~USD 50-100 million annually) to develop next-generation antiseptics, guarded by patents that prolong exclusivity. Investment focuses on improving formulation safety, expanding indications, and enhancing delivery systems.

Emerging Market Opportunities

Rapid economic growth, expanding healthcare infrastructure, and rising surgical procedures position emerging markets as lucrative avenues. Local manufacturing, combined with technology transfer, reduces costs and accelerates adoption, creating attractive financial prospects.

Challenges Affecting Financial Trajectory

• Patent expirations could lead to generic competition, reducing prices and margins.
• Regulatory revisions may necessitate reformulation or new trials, increasing costs.
• Competitive pressures from alternative antiseptics or new antimicrobial technologies could erode market share.

Future Outlook and Trends

Growth Projections

The antiseptic segment, with Chloraprep with TINT as a leader, is projected to grow at a CAGR of approximately 5% to 6% through 2030. In markets where surgical volumes increase and infection control policies tighten, this growth could surpass estimates.

Innovation and Market Expansion

Emerging trends include:

• Integration with antimicrobial coatings for medical devices.
• Developing formulations with enhanced safety profiles for vulnerable populations.
• Expanding indications into dermatology and outpatient procedures.

Market Challenges and Opportunities

While innovation offers a window for market expansion, challenges related to antimicrobial resistance, regulatory hurdles, and cost pressures persist. Companies that innovate around safety, efficacy, and cost-efficiency will capture more significant market share.

Key Takeaways

• Dominant Role in Infection Control: Chloraprep with TINT remains a cornerstone in preoperative skin antisepsis, driven by its proven efficacy and regulatory endorsement.
• Market Growth Driven by Surgical Volume: Rising global surgical procedures and favorable infection control policies underpin steady market expansion.
• Competitive and Regulatory Landscape: Entrenched market players benefit from patent protections and regulatory approvals, but emerging innovations could disrupt the status quo.
• Financial Robustness and Challenges: Leading manufacturers enjoy high margins and growth prospects, though patent expirations and regulatory shifts necessitate adaptation.
• Future Prospects: Continued R&D, regional market expansion, and integration into broader antimicrobial and infection prevention strategies will shape the product’s financial trajectory.

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FAQs

1. What factors contribute most to Chloraprep with TINT's market dominance?
Clinical efficacy, regulatory approval, brand reputation, and consistent supply chain logistics solidify its market position. Its tinted formulation enhances safety by ensuring complete skin coverage, a feature favored by healthcare providers.

2. How are regulatory changes affecting the future of Chloraprep with TINT?
Regulatory authorities are scrutinizing alcohol-based antiseptics for safety concerns, potentially necessitating reformulations or new approvals. However, existing approvals and robust clinical data provide a buffer, allowing continued market presence.

3. What emerging innovations could impact the market for Chloraprep with TINT?
Developments include antimicrobial-coated medical devices, sustained-release antiseptic formulations, and products with improved safety profiles, all of which could compete with or complement existing antiseptics.

4. How do regional healthcare policies influence the product's market performance?
Regions with supportive reimbursement frameworks and infection control mandates see higher adoption rates. Conversely, cost-sensitive markets may favor low-cost generics, impacting profitability.

5. What is the outlook for patent expirations related to Chloraprep with TINT?
Patent expirations in the coming years could lead to increased generic competition, pressuring prices and margins but also broadening accessibility in lower-income regions.

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References

[1] CDC Guideline for Prevention of Surgical Site Infection. Centers for Disease Control and Prevention, 2017.

[2] World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection. 2016.

[3] MarketsandMarkets. Preoperative Skin Antiseptics Market by Product, Application, End-User – Global Forecast to 2030, 2022.

[4] IBISWorld. Global Healthcare Supplies Market Size, 2022.

[5] U.S. Food and Drug Administration. Regulations for Medical Products, 2023.

[6] Company Annual Reports. 2022-2023.

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By understanding these market drivers, regulatory factors, and innovation trajectories, stakeholders can better position their investments and strategies within the antiseptic segment, ensuring resilience amid evolving healthcare demands.