CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - Generic Drug Details

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

Chlorhexidine gluconate; isopropyl alcohol is the generic ingredient in ten branded drugs marketed by 3m Health Care, Becton Dickinson Co, and Prof Dspls, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorhexidine gluconate; isopropyl alcohol has twenty-two patent family members in twelve countries.

Four suppliers are listed for this compound.

Summary for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

International Patents:	22
US Patents:	2
Tradenames:	10
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	4
Clinical Trials:	24
DailyMed Link:	CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Constraining patent/regulatory exclusivity:

REVISIONS TO THE LABELING TO DESCRIBE MODIFIED FORMULATION BASED ON RESULTS OF STUDIES EM-05-014624 AND EM-05-014815

Dosage:

SOLUTION;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 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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

Sponsor	Phase
Yaneve Fonge	Phase 4
University of Wisconsin, Madison	Phase 4
University of California, San Diego	N/A

See all CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL clinical trials

Pharmacology for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Physiological Effect

Decreased Cell Wall Integrity

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

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 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prof Dspls	PREVANTICS SWAB	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021524-001	Jun 3, 2005		OTC	Yes	Yes
Prof Dspls	PREVANTICS MAXI SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021524-003	Jun 3, 2005		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-006	Nov 21, 2006		OTC	Yes	Yes	6,991,394		Y
Becton Dickinson Co	CHLORAPREP TRIPLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-003	Jun 10, 2009		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-008	Oct 23, 2008		OTC	Yes	Yes
3m Health Care	SOLUPREP S	chlorhexidine gluconate; isopropyl alcohol	SOLUTION;TOPICAL	208288-001	Aug 8, 2018		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005		OTC	Yes	Yes	7,422,388		Y

Expired US Patents for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

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
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	6,991,394
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006	7,241,065
Becton Dickinson Co	CHLORAPREP SINGLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-002	May 10, 2005	5,690,958
Becton Dickinson Co	CHLORAPREP ONE-STEP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-006	Nov 21, 2006	5,690,958
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002	D386849
Prof Dspls	PREVANTICS MAXI SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021524-003	Jun 3, 2005	D468424

International Patents for CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

Country	Patent Number	Title	Estimated Expiration
Portugal	1581300
Mexico	PA05007458	APLICADOR DE LIQUIDO CON UN MECANISMO PARA FRACTURAR MULTIPLES AMPOLLAS. (LIQUID APPLICATOR WITH A MECHANISM FOR FRACTURING MULTIPLE AMPOULES.)
Canada	2512593	APPLICATEUR DE LIQUIDE DOTE D'UN MECANISME PERMETTANT DE BRISER PLUSIEURS AMPOULES (LIQUID APPLICATOR WITH A MECHANISM FOR FRACTURING MULTIPLE AMPOULES)
Canada	2519176	APPLICATEUR DE LIQUIDE POUR LA COLORATION D'UN LIQUIDE (LIQUID APPLICATOR FOR COLORING A LIQUID)
Japan	5019711
European Patent Office	3117866	APPLICATEUR DE LIQUIDE POUR LA COLORATION D'UN LIQUIDE (LIQUID APPLICATOR FOR COLORING A LIQUID)
Australia	2004220817	Liquid applicator for coloring a liquid

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL Market Analysis and Financial Projection Experimental

Chlorhexidine Gluconate and Isopropyl Alcohol: Market Dynamics and Financial Trajectory

Market Overview

Chlorhexidine gluconate (CHG) combined with isopropyl alcohol is a potent antiseptic solution widely used in various medical and hygiene applications. This market is driven by several key factors, including the increasing demand for effective antiseptic agents, the rise in surgical procedures, and the growing need for infection control measures.

Market Size and Forecast

The global chlorhexidine gluconate solution market was valued at USD 181.3 million in 2022 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 1.90% during the forecast period[3].

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

Key Drivers

Rise in Surgical Procedures

The increasing number of surgical procedures in hospitals is a significant driver for the market. Chlorhexidine gluconate is extensively used as an antiseptic agent to clean the skin before surgical procedures, reducing the risk of infections[3].

Growing Geriatric Population

The rising geriatric population, particularly in regions like North America and the Asia-Pacific, is contributing to the market growth. Older populations often require more medical interventions, including surgeries, which in turn increases the demand for CHG solutions[3].

Increased Demand for Hand Sanitizers and Disinfectants

The COVID-19 pandemic has accelerated the demand for hand sanitizers and disinfectants, further boosting the market for CHG solutions. The use of CHG in hand rubs has become a daily necessity, especially in healthcare settings[1].

Market Restraints

Volatility in Raw Material Prices

Fluctuations in the prices of raw materials required for the production of chlorhexidine gluconate solutions are a major restraint. Increases in the cost of ingredients such as chlorhexidine gluconate, isopropyl alcohol, and other components can make production challenging for manufacturers[3].

Adverse Reactions and Safety Concerns

Although rare, chlorhexidine gluconate can cause allergic reactions, including generalized allergic reactions and anaphylactic shock. Additionally, isopropyl alcohol can cause skin irritation and other local symptoms. These safety concerns can impact market growth[4].

Regional Analysis

North America

North America dominates the chlorhexidine gluconate solution market due to its advanced healthcare facilities and higher spending on healthcare. The region accounted for the largest revenue share in 2022, driven by factors such as the high geriatric population and extensive use in surgical hand rubs[1][3].

Asia-Pacific

The Asia-Pacific region is expected to register the fastest revenue growth rate over the forecast period. This growth is attributed to the increasing geriatric population and rising healthcare spending in countries like China, India, and others[3].

Europe

Europe is also expected to see steady growth, driven by the increasing number of surgical procedures, such as angioplasty surgeries, and the growing geriatric population. The European Commission reports a significant rise in healthcare spending and surgical procedures in the region[3].

Product Type Segmentation

The global chlorhexidine gluconate solution market is segmented into different concentrations, including 2% CHG, 4% CHG, and 20% CHG solutions.

• 2% CHG Solution: This is the most widely used concentration, particularly in skin preparation for surgery, hand rubs, and general wound cleaning. It is also used in daily washing and for umbilical cord care[1].
• 4% CHG Solution: Commonly used in clinics, this concentration is often diluted to 2% for various applications[3].

Clinical Efficacy and Safety

Combination with Isopropyl Alcohol

The combination of chlorhexidine gluconate with isopropyl alcohol (e.g., ChloraPrep) has been shown to be highly effective in reducing skin bacterial load. This combination provides both immediate and persistent antimicrobial properties, outperforming individual components and other antiseptics like povidone-iodine[4].

Meta-analyses and Clinical Studies

Meta-analyses have demonstrated that the combination of CHG and alcohol is significantly better than aqueous povidone-iodine alone in preventing infections. However, there is a need for correct attribution of efficacy, as some studies incorrectly attribute the benefits solely to CHG without considering the role of alcohol[2].

Competitive Landscape

The global chlorhexidine gluconate solution market is fragmented, with several key players dominating the market. These companies are involved in various strategies such as mergers and acquisitions, strategic agreements, and the development of new products to maintain their market position[3].

Key Aspects Covered

• Market Dynamics: The market is driven by the increasing demand for antiseptic agents, the rise in surgical procedures, and the growing geriatric population.
• Segmentation Analysis: The market is segmented by product type (2% CHG, 4% CHG, 20% CHG) and geography (North America, Asia-Pacific, Europe).
• Market Size and Forecast: The market is expected to grow at a CAGR of 1.90% during the forecast period.
• Competitive Landscape: The market is fragmented with key players adopting various strategies to maintain their market share.

Key Takeaways

• The global chlorhexidine gluconate solution market is expected to grow significantly driven by increasing surgical procedures and the growing geriatric population.
• The combination of CHG with isopropyl alcohol is highly effective in infection control.
• North America and the Asia-Pacific region are key markets due to their advanced healthcare facilities and growing geriatric populations.
• Volatility in raw material prices and safety concerns are major restraints.

FAQs

What is the primary use of chlorhexidine gluconate solution in healthcare?

Chlorhexidine gluconate solution is primarily used as an antiseptic agent for skin preparation before surgical procedures, hand rubs, and wound care.

How does the combination of CHG and isopropyl alcohol work?

The combination provides both immediate and persistent antimicrobial properties, with isopropyl alcohol offering rapid kill of microorganisms and CHG providing a residual effect that prevents regrowth[4].

What are the major drivers of the chlorhexidine gluconate solution market?

The major drivers include the rise in surgical procedures, the growing geriatric population, and the increased demand for hand sanitizers and disinfectants.

Which region dominates the chlorhexidine gluconate solution market?

North America dominates the market due to its advanced healthcare facilities and higher spending on healthcare[1][3].

What are the potential restraints for the market growth?

Volatility in raw material prices and adverse reactions such as allergic reactions and skin irritation are significant restraints[3][4].

Sources

1. IndustryARC: Chlorhexidine Gluconate Solution Market Overview - IndustryARC
2. PLOS ONE: The Forgotten Role of Alcohol: A Systematic Review and Meta-Analysis
3. Emergen Research: Chlorhexidine Gluconate Solution Market Size - Emergen Research
4. Medicines.org.uk: ChloraPrep Clear - Summary of Product Characteristics (SmPC)