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. Four 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:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	45
DailyMed Link:	CHLORAPREP WITH TINT at DailyMed

Recent Clinical Trials for CHLORAPREP WITH TINT

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 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	5,690,958
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	7,182,536
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	6,536,975
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006	6,536,975
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	6,729,786
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	5,538,353
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	7,241,065

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
Brazil	PI0408318	aplicador de lìquido para aplicar um lìquido desejado a uma superfìcie
Germany	60325094
Russian Federation	2200532	DOSAGE APPLICATOR OF BACTERICIDAL SUBSTANCE AND METHOD FOR ITS MANUFACTURING
Mexico	9801347	APLICADOR DE LIQUIDO. (LIQUID APPLICATOR.)
Spain	2280418
Japan	2006520271
World Intellectual Property Organization (WIPO)	9707729

Market Dynamics and Financial Trajectory for ChloraPrep with Tint

Overview of ChloraPrep with Tint

ChloraPrep with Tint, a product of CareFusion (now part of Becton, Dickinson and Company), is a widely used antiseptic solution for pre-operative and pre-injection skin preparation. The solution combines 2% chlorhexidine gluconate and 70% isopropyl alcohol, making it highly effective in preventing surgical site infections.

Market Size and Growth

The global skin antiseptic products market, which includes ChloraPrep with Tint, 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 around USD 6.50 billion by 2034, growing at a CAGR of 6.64% from 2024 to 2034[1].

Regional Dominance

North America, particularly the U.S., dominates the global skin antiseptic products market. The U.S. market size was valued at USD 760 million in 2023 and is expected to grow to around USD 1.56 billion by 2034, with a CAGR of 7% from 2024 to 2034. This growth is driven by the increased penetration of healthcare units, rising number of surgeries, and a growing geriatric population[1].

Product Efficacy and Market Impact

ChloraPrep with Tint has been clinically proven to be highly effective in preventing infections. A study published in the New England Journal of Medicine found that ChloraPrep reduced the risk of surgical site infections by 41% compared to povidone-iodine[2][3].

Clinical Evidence

The efficacy of ChloraPrep is supported by multiple independent clinical organizations, including the Centers for Disease Control and Prevention (CDC), which acknowledges chlorhexidine gluconate as a superior agent for prepping skin prior to invasive procedures[2].

Market Segments and Competition

Formulation Segment

The alcohol segment, which includes ChloraPrep with Tint, dominated the global skin antiseptic products market in 2023 in terms of revenue. This dominance is attributed to the effective antiseptic properties of alcohol-based solutions and wipes, which are extensively used in pre-injection and pre-operative skin preparation[1].

Competitive Landscape

While ChloraPrep with Tint is a market leader, other products like Hibiclens (chlorhexidine) and generic alternatives are also present in the market. However, ChloraPrep's unique formulation and clinical evidence support its strong market position[4].

Financial Trajectory

Historical Sales

ChloraPrep was a significant revenue generator for CareFusion, with sales of $193 million in 2010, making it the No. 1 drug in its class at that time[3].

Controversies and Settlements

Despite its success, ChloraPrep was involved in a controversy related to financial ties and alleged kickbacks. CareFusion agreed to a $41 million settlement with the U.S. Justice Department to resolve allegations that the company paid Dr. Charles Denham to influence patient safety standards and boost sales of ChloraPrep[3].

Future Outlook

Growing Demand

The demand for skin antiseptic products, including ChloraPrep with Tint, is expected to rise due to several factors:

• Technological Innovations: The increasing popularity of minimal invasive surgeries and technological advancements in healthcare are boosting the consumption of skin antiseptic products[1].
• COVID-19 Impact: The COVID-19 pandemic and vaccination drives have increased the use of antiseptics for pre-injection skin preparation, positively impacting the market[1].
• Global Population Growth: The growing global population and rising consumer expenditure on health and wellness are expected to further drive the market growth[1].

Regional Opportunities

Asia Pacific is expected to be the most opportunistic market during the forecast period due to the rising penetration of hospitals and clinics, increasing government expenditure on healthcare infrastructure, and a large population with a rising number of accidents and surgeries[1].

Key Takeaways

• ChloraPrep with Tint is a leading antiseptic solution with proven efficacy in preventing surgical site infections.
• The global skin antiseptic products market, driven by North America, is expected to grow significantly by 2034.
• The product's market position is supported by strong clinical evidence and its widespread use in pre-operative and pre-injection skin preparation.
• Despite past controversies, the future outlook for ChloraPrep with Tint remains positive due to growing demand and technological advancements.

FAQs

What is the primary active ingredient in ChloraPrep with Tint?

The primary active ingredients in ChloraPrep with Tint are 2% chlorhexidine gluconate and 70% isopropyl alcohol[2].

How effective is ChloraPrep with Tint in preventing infections?

ChloraPrep with Tint has been shown to reduce the risk of surgical site infections by 41% compared to povidone-iodine[2][3].

What regions are driving the growth of the skin antiseptic products market?

North America currently dominates the market, but Asia Pacific is expected to be the most opportunistic region during the forecast period[1].

What controversies has ChloraPrep been involved in?

ChloraPrep was involved in a controversy related to financial ties and alleged kickbacks, leading to a $41 million settlement with the U.S. Justice Department[3].

How has the COVID-19 pandemic impacted the demand for ChloraPrep with Tint?

The COVID-19 pandemic and vaccination drives have increased the use of antiseptics for pre-injection skin preparation, positively impacting the consumption of ChloraPrep with Tint[1].

Sources

1. Precedence Research: "Skin Antiseptic Products Market Size to Hit USD 6.50 Bn by 2034"
2. MassDevice: "NEJM backs ChloraPrep study in patient safety scandal"
3. ProPublica: "Hidden Financial Ties Rattle Top Health Quality Group"
4. Drugs.com: "ChloraPrep One-Step Alternatives Compared"