ALCOHOL; CHLORHEXIDINE GLUCONATE - Generic Drug Details

What are the generic drug sources for alcohol; chlorhexidine gluconate and what is the scope of freedom to operate?

Alcohol; chlorhexidine gluconate is the generic ingredient in one branded drug marketed by 3M and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ALCOHOL; CHLORHEXIDINE GLUCONATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	38
DailyMed Link:	ALCOHOL; CHLORHEXIDINE GLUCONATE at DailyMed

Recent Clinical Trials for ALCOHOL; CHLORHEXIDINE GLUCONATE

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

Sponsor	Phase
Yaneve Fonge	Phase 4
Sunnybrook Health Sciences Centre	Phase 4
Rafik Batroussy	Phase 2

See all ALCOHOL; CHLORHEXIDINE GLUCONATE clinical trials

Pharmacology for ALCOHOL; CHLORHEXIDINE GLUCONATE

Physiological Effect

Decreased Cell Wall Integrity

Anatomical Therapeutic Chemical (ATC) Classes for ALCOHOL; CHLORHEXIDINE GLUCONATE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

B05CA	Antiinfectives
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

D08AC	Biguanides and amidines
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

D09AA	Medicated dressings with antiinfectives
D09A	MEDICATED DRESSINGS
D09	MEDICATED DRESSINGS
D	Dermatologicals

R02AA	Antiseptics
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01AX	Other antiinfectives
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for ALCOHOL; CHLORHEXIDINE GLUCONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
3m	AVAGARD	alcohol; chlorhexidine gluconate	SOLUTION;TOPICAL	021074-001	Jun 7, 2001		OTC	Yes	Yes

Expired US Patents for ALCOHOL; CHLORHEXIDINE GLUCONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
3m	AVAGARD	alcohol; chlorhexidine gluconate	SOLUTION;TOPICAL	021074-001	Jun 7, 2001
3m	AVAGARD	alcohol; chlorhexidine gluconate	SOLUTION;TOPICAL	021074-001	Jun 7, 2001
3m	AVAGARD	alcohol; chlorhexidine gluconate	SOLUTION;TOPICAL	021074-001	Jun 7, 2001
3m	AVAGARD	alcohol; chlorhexidine gluconate	SOLUTION;TOPICAL	021074-001	Jun 7, 2001
3m	AVAGARD	alcohol; chlorhexidine gluconate	SOLUTION;TOPICAL	021074-001	Jun 7, 2001

ALCOHOL; CHLORHEXIDINE GLUCONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorhexidine Gluconate Solution

Introduction to Chlorhexidine Gluconate Solution

Chlorhexidine gluconate (CHG) is a biguanide compound widely used as an antiseptic agent for its tropical antibacterial activity. It is available in various concentrations, most commonly as 2% and 4% solutions, and is integral in surgical hand scrubs, skin disinfection, wound care, and oral hygiene.

Market Size and Growth Projections

The global chlorhexidine gluconate solution market is anticipated to experience steady growth over the coming years. As of 2022, the market size was valued at USD 181.3 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 1.90% during the forecast period[5].

By 2026, the market is forecast to reach $196.1 million, growing at a CAGR of 3.2% from 2021 to 2026[1].

Key Drivers of Market Growth

Rising Demand for Hand Sanitizers and Disinfectants

The COVID-19 pandemic has significantly increased the demand for hand sanitizers and disinfectants, driving the growth of the CHG solution market. The use of CHG in hand rubs has become a daily necessity, contributing to the market's expansion[1].

Growing Geriatric Population

The increasing geriatric population globally, particularly in regions like North America, Europe, and Asia-Pacific, is a major factor driving market growth. Older populations require more healthcare services, including surgical procedures, which in turn increase the demand for CHG solutions[5].

Expansion of Healthcare Facilities

The global expansion of healthcare facilities and the rise in the number of surgical procedures are also driving the market. CHG is crucial in preoperative skin preparation and in preventing hospital-acquired infections[5].

Geographical Market Analysis

North America

North America dominated the CHG solution market in 2020, with a market share of 39%. This is attributed to the region's advanced healthcare facilities and higher healthcare spending. The United States alone spent USD 4.3 trillion on healthcare in 2021, which is significantly higher than other countries[5].

Asia-Pacific

The Asia-Pacific region is expected to lead the market in the future due to rising healthcare industries in countries like China and India. The growing geriatric population and increasing life expectancy in this region are key factors contributing to market growth[1].

Europe

Europe is also expected to see steady growth in the CHG solution market, driven by an aging population and an increase in surgical procedures such as angioplasty. European countries reported a significant number of angioplasty surgeries in 2021, further boosting the demand for CHG solutions[5].

Market Segmentation

By Type

The market is segmented by type, with 2% CHG solutions holding the largest share (36% in 2020). These solutions are used in various applications, including skin preparation for surgery, hand rubs, invasive solutions, and general wound cleaning. The 4% CHG solutions also hold a significant share due to their widespread use in clinics and hospitals[1].

By Application

The surgical hand rub segment leads the market in terms of application. CHG solutions are essential for preoperative skin preparation and in preventing hospital-acquired infections. Other significant applications include wound care, hand washes, preoperative body showers, and oral hygiene[1].

Financial Trajectory

Revenue Growth

The global CHG solution market has seen significant revenue growth. For instance, the market revenue is expected to grow from USD 181.3 million in 2022 to USD 196.1 million by 2026. This growth is driven by increasing demand and expanding healthcare facilities[1][5].

Cost-Benefit Analysis

A cost-benefit analysis of using CHG dressings on central venous catheters indicates substantial potential savings. Estimated annual U.S. net benefits from CHG dressing use range from $275 million to $1.97 billion, highlighting the economic viability of using CHG solutions in healthcare settings[4].

Challenges and Restraints

Fluctuation in Raw Material Prices

Volatility in the prices of raw materials required for CHG solution production is a significant restraint. This fluctuation can make it challenging for manufacturers to maintain consistent production costs, potentially affecting market growth[5].

Government Regulations

Stringent government regulations regarding the use of chemicals can also act as a barrier to market growth. Compliance with these regulations can increase production costs and complexity for manufacturers[1].

Market Landscape and Competitive Analysis

The global CHG solution market is fragmented, with several key players dominating the market. These players are engaging in various strategies such as mergers and acquisitions, strategic agreements, and the development of new products to maintain their market position[5].

Innovations and Trends

Environmentally Friendly Formulations

There is a growing trend towards environmentally friendly formulations and enhanced packaging designs. Innovations in wipe textures and the integration of telemedicine and remote care are also shaping the market[3].

Focus on OTC and Retail Market

The market is seeing an increased focus on over-the-counter (OTC) and retail segments, driven by consumer awareness and demand for hygiene products[3].

Key Takeaways

• The global chlorhexidine gluconate solution market is expected to grow at a CAGR of 1.90% during the forecast period.
• The market is driven by the rising demand for hand sanitizers and disinfectants, a growing geriatric population, and the expansion of healthcare facilities.
• North America currently dominates the market, but the Asia-Pacific region is expected to lead in the future.
• The 2% CHG solution segment holds the largest market share.
• Volatility in raw material prices and stringent government regulations are significant restraints.

Frequently Asked Questions (FAQs)

Q: What is the primary use of chlorhexidine gluconate solution? A: Chlorhexidine gluconate solution is primarily used as an antiseptic agent for skin disinfection, surgical hand scrubs, wound care, and oral hygiene.

Q: Which region dominates the chlorhexidine gluconate solution market? A: North America currently dominates the market, but the Asia-Pacific region is expected to lead in the future.

Q: What are the key drivers of the chlorhexidine gluconate solution market? A: The key drivers include the rising demand for hand sanitizers and disinfectants, a growing geriatric population, and the expansion of healthcare facilities.

Q: What are the challenges facing the chlorhexidine gluconate solution market? A: The challenges include fluctuation in raw material prices and stringent government regulations regarding the use of chemicals.

Q: What is the expected market size of the chlorhexidine gluconate solution market by 2026? A: The market is forecast to reach $196.1 million by 2026.

Cited Sources

1. IndustryARC: Chlorhexidine Gluconate Solution Market Overview[1]
2. Mziq: Afya Limited Announces Fourth-Quarter and Full Year 2020 Results[2]
3. The Business Research Company: Global Chlorhexidine Gluconate CHG Wipes Market Report 2024[3]
4. PubMed: Cost-benefit analysis of chlorhexidine gluconate dressing[4]
5. Emergen Research: Chlorhexidine Gluconate Solution Market Size[5]