CHLORHEXIDINE GLUCONATE Drug Patent Profile

When do Chlorhexidine Gluconate patents expire, and when can generic versions of Chlorhexidine Gluconate launch?

Chlorhexidine Gluconate is a drug marketed by Sage Prods, Bajaj, Chartwell Rx, Lyne, Pharm Assoc, Sciegen Pharms Inc, Xttrium, Becton Dickinson, and Kendall Il. and is included in ten NDAs. There are four patents protecting this drug.

This drug has three patent family members in one country.

The generic ingredient in CHLORHEXIDINE GLUCONATE is chlorhexidine gluconate. There are fifty-eight drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Chlorhexidine Gluconate

A generic version of CHLORHEXIDINE GLUCONATE was approved as chlorhexidine gluconate by BECTON DICKINSON on October 24^th, 1989.

Summary for CHLORHEXIDINE GLUCONATE

International Patents:	3
US Patents:	4
Applicants:	9
NDAs:	10
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	158
Patent Applications:	6,020
Drug Prices:	Drug price information for CHLORHEXIDINE GLUCONATE
What excipients (inactive ingredients) are in CHLORHEXIDINE GLUCONATE?	CHLORHEXIDINE GLUCONATE excipients list
DailyMed Link:	CHLORHEXIDINE GLUCONATE at DailyMed

See drug prices for CHLORHEXIDINE GLUCONATE

See drug sales revenues for CHLORHEXIDINE GLUCONATE

Recent Clinical Trials for CHLORHEXIDINE GLUCONATE

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

Sponsor	Phase
McMaster University	Phase 3
Hamilton Health Sciences Corporation	Phase 3
Ontario Clinical Oncology Group (OCOG)	Phase 3

See all CHLORHEXIDINE GLUCONATE clinical trials

Pharmacology for CHLORHEXIDINE GLUCONATE

Physiological Effect

Decreased Cell Wall Integrity

Medical Subject Heading (MeSH) Categories for CHLORHEXIDINE GLUCONATE

Anti-Infective Agents, Local

Disinfectants

Mouthwashes

Anatomical Therapeutic Chemical (ATC) Classes for 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 CHLORHEXIDINE GLUCONATE

CHLORHEXIDINE GLUCONATE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005		OTC	Yes	Yes	7,935,093		Y
Lyne	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	SOLUTION;DENTAL	074291-001	Dec 28, 1995	AT	RX	No	No
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005		OTC	Yes	Yes	7,427,574		Y

Expired US Patents for CHLORHEXIDINE GLUCONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005	7,066,916
Sage Prods	CHLORHEXIDINE GLUCONATE	chlorhexidine gluconate	CLOTH;TOPICAL	021669-001	Apr 25, 2005	7,595,021

International Patents for CHLORHEXIDINE GLUCONATE

See the table below for patents covering CHLORHEXIDINE GLUCONATE around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2551688	DEBARBOUILLETTE NON TISSEE AMELIOREE (IMPROVED NON-WOVEN WASH CLOTH)
Canada	2467150	DISPOSITIF D'ADMINISTRATION DE DESINFECTANT ET METHODE DE DESINFECTION SANS ALCOOL (DISINFECTANT DELIVERY SYSTEM AND METHOD OF PROVIDING ALCOHOL-FREE DISINFECTION)
Canada	2467155	DISPOSITIF D'ADMINISTRATION DE DESINFECTANT ET METHODE DE DESINFECTION SANS ALCOOL (DISINFECTANT DELIVERY SYSTEM AND METHOD OF PROVIDING ALCOHOL-FREE DISINFECTION)

CHLORHEXIDINE GLUCONATE Market Analysis and Financial Projection Experimental

Chlorhexidine Gluconate Market Dynamics and Financial Trajectory

Market Overview

Chlorhexidine gluconate (CHG) is a widely used antiseptic agent known for its broad-spectrum antibacterial activity. It is available in various forms, including solutions, wipes, and dressings, and is integral in healthcare settings for preventing infections.

Market Size and Growth

The global chlorhexidine gluconate solution market is projected to experience steady growth over the coming years. As of 2022, the market size was estimated at USD 181.3 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 1.90% during the forecast period[4].

Forecast and Projections

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

In the context of CHG wipes, the market is even more robust, with a projected size of $49.92 billion in 2024, growing from $47.4 billion in 2023 at a CAGR of 5.3%. This segment is expected to reach $61.46 billion by 2028[3].

Market Drivers

Increasing Surgical Procedures

The rise in the number of surgical procedures in hospitals is a significant driver for the chlorhexidine gluconate solution market. CHG is crucial for preoperative skin preparation and surgical hand rubs, reducing the risk of Surgical Site Infections (SSIs)[4].

Growing Geriatric Population

The increasing geriatric population, particularly in regions like North America and Asia-Pacific, is driving the demand for CHG solutions. This demographic shift leads to higher healthcare spending and an increased need for antiseptic agents[4].

Pandemic-Driven Hygiene Measures

The COVID-19 pandemic has heightened the importance of hygiene measures, including the use of hand sanitizers and disinfectants. This has boosted the demand for chlorhexidine gluconate solutions and wipes[3].

Regulatory Endorsement

Regulatory endorsements and guidelines emphasizing infection control have also contributed to the growth of the CHG market. Governments and health organizations have recommended the use of CHG for various medical applications, further driving its adoption[3].

Market Restraints

Volatility in Raw Material Prices

Fluctuations in the prices of raw materials required for the production of chlorhexidine gluconate solutions can act as a restraint. This volatility can lead to the emergence of substitutes and affect the overall market growth[4].

Stringent Regulatory Frameworks

Strict government regulations regarding the use of chemicals can also hinder the growth of the CHG market. Compliance with these regulations can increase costs and complexity for manufacturers[1].

Potential Health Risks

Research has indicated that high concentrations of chlorhexidine can be harmful, affecting various cells in the human body, such as gingival fibroblasts and osteoblastic cells. This could lead to cautious use and potential regulatory scrutiny[5].

Market Segmentation

By Type

The chlorhexidine gluconate solution market is segmented by type, with 2% CHG solutions holding the largest share. These solutions are used with and without isopropyl alcohol for various applications, including skin preparation for surgery, hand rubs, and wound cleaning[1].

By Application

The market is segmented by application into preoperative skin preparation, surgical hand rub, skin wound and general skin cleanser, and healthcare personal hand hygiene. The surgical hand rub segment accounted for the largest revenue share in 2022[4].

By Distribution Channel

CHG wipes are distributed through various channels, including pharmacies, supermarkets, specialty stores, and direct sales. This diverse distribution network ensures wide availability and accessibility[3].

By End User

The end users of CHG solutions and wipes include hospitals, clinics, ambulatory surgical centers, and other healthcare facilities. North America, with its advanced healthcare infrastructure, dominates the market, followed by Asia-Pacific and Europe[4].

Geographic Analysis

North America

North America leads the chlorhexidine gluconate solution market due to its well-developed healthcare sector and higher spending on healthcare. The region's aging population and the presence of advanced medical facilities are key factors driving this market[1][4].

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, rising healthcare spending, and expanding healthcare facilities in countries like China and India[4].

Europe

Europe is expected to experience steady growth, driven by an aging population and an increase in surgical procedures such as angioplasty. The European Commission's data indicates a significant rise in healthcare spending and surgical procedures in the region[4].

Cost-Benefit Analysis

The use of chlorhexidine gluconate dressings has been shown to have significant cost-benefit advantages. A study estimated that the potential annual U.S. net benefits from chlorhexidine dressing use could range from $275 million to $1.97 billion, along with a reduction in local infections, catheter-related bloodstream infections (CRBSIs), and mortality[2].

Competitive Landscape

The global chlorhexidine gluconate solution market is fragmented, with several key players dominating the market. These companies are engaging in strategies such as mergers and acquisitions, strategic agreements, and the development of new products to maintain their market share[4].

Key Takeaways

• The chlorhexidine gluconate solution market is expected to grow steadily, driven by increasing surgical procedures and a growing geriatric population.
• The market is segmented by type, application, distribution channel, and end user, with North America leading the global market.
• Regulatory endorsements and pandemic-driven hygiene measures are significant drivers.
• Volatility in raw material prices and potential health risks are key restraints.
• The use of CHG dressings and solutions offers substantial cost-benefit advantages.

FAQs

What are the primary applications of chlorhexidine gluconate solutions?

Chlorhexidine gluconate solutions are primarily used for preoperative skin preparation, surgical hand rubs, skin wound and general skin cleansing, and healthcare personal hand hygiene[4].

How does the COVID-19 pandemic impact the chlorhexidine gluconate market?

The COVID-19 pandemic has increased the demand for chlorhexidine gluconate solutions and wipes due to heightened hygiene measures and the need for effective antiseptic agents[3].

What are the potential health risks associated with chlorhexidine gluconate?

High concentrations of chlorhexidine gluconate can be harmful, affecting cells such as gingival fibroblasts, gingival epithelial cells, and osteoblastic cells. However, when used correctly, it remains a valuable tool in infection control[5].

Which region dominates the chlorhexidine gluconate solution market?

North America dominates the chlorhexidine gluconate solution market due to its advanced healthcare infrastructure and higher healthcare spending[1][4].

What is the projected market size of the chlorhexidine gluconate solution market by 2026?

The chlorhexidine gluconate solution market is forecast to reach $196.1 million by 2026, growing at a CAGR of 3.2% from 2021 to 2026[1].

How does the cost-benefit analysis of chlorhexidine gluconate dressings look?

The use of chlorhexidine gluconate dressings can result in significant cost savings, ranging from $275 million to $1.97 billion annually in the U.S., along with reduced infections and mortality[2].

Sources

1. IndustryARC: Chlorhexidine Gluconate Solution Market Overview - IndustryARC
2. PubMed: Cost-benefit analysis of chlorhexidine gluconate dressing...
3. The Business Research Company: Global Chlorhexidine Gluconate CHG Wipes Market Report 2024
4. Emergen Research: Chlorhexidine Gluconate Solution Market Size - Emergen Research
5. Today's RDH: Chlorhexidine: An Update - Today's RDH