Chlorhexidine gluconate; isopropyl alcohol - Generic Drug Details

What are the generic drug sources for chlorhexidine gluconate; isopropyl alcohol and what is the scope of patent protection?

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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Chlorhexidine gluconate; isopropyl alcohol has ten patent family members in eight countries.

Five suppliers are listed for this compound.

Summary for chlorhexidine gluconate; isopropyl alcohol

International Patents:	10
US Patents:	1
Tradenames:	10
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	5
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

Constraining patent/regulatory exclusivity:

7,422,388

Dosage:

SPONGE;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 MAXI SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021524-003	Jun 3, 2005		OTC	Yes	Yes
Prof Dspls	PREVANTICS SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021524-002	Jun 3, 2005		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP SINGLE SWABSTICK	chlorhexidine gluconate; isopropyl alcohol	SWAB;TOPICAL	021555-002	May 10, 2005		OTC	Yes	Yes
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-005	Apr 3, 2006		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 WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-002	May 3, 2005	6,991,394
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
Becton Dickinson Co	CHLORAPREP WITH TINT	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-007	Oct 10, 2006	6,536,975

International Patents for chlorhexidine gluconate; isopropyl alcohol

Country	Patent Number	Title	Estimated Expiration
Mexico	PA05009881	APLICADOR DE LIQUIDO PARA COLOREAR UN LIQUIDO. (LIQUID APPLICATOR FOR COLORING A LIQUID.)
Japan	2006520271
Australia	2004220817	Liquid applicator for coloring a liquid
Spain	2601493

Market Dynamics and Financial Trajectory for Chlorhexidine Gluconate and Isopropyl Alcohol

Last updated: July 29, 2025

Introduction

Chlorhexidine gluconate and isopropyl alcohol are pivotal disinfectants with extensive applications in healthcare, sanitation, and consumer hygiene markets. Their widespread use, regulatory landscape, competitive environment, and evolving market trends dictate their market dynamics and financial outlooks. This analysis provides a comprehensive assessment of these agents’ current market positions, underlying drivers, and future financial trajectories.

Market Overview

Chlorhexidine Gluconate

Chlorhexidine gluconate is an antiseptic agent widely employed in surgical scrubs, preoperative skin preparations, wound disinfectants, and oral rinses. Its proven efficacy against bacteria, fungi, and some viruses underpins its dominance in clinical settings. The global chlorhexidine market was valued at approximately USD 600 million in 2022, with projections indicating a compound annual growth rate (CAGR) of 4-6% through 2030 [1].

Isopropyl Alcohol

Isopropyl alcohol, also known as 2-propanol, is utilized primarily as a disinfectant and solvent in clinical, industrial, and household environments. Its rapid evaporation and broad-spectrum antimicrobial activity sustain its demand. The global isopropyl alcohol market was valued at over USD 4 billion in 2022, with a CAGR estimated around 5-7% over the next decade [2].

Market Drivers

Healthcare-Driven Demand

The COVID-19 pandemic accelerated demand for disinfectants, especially alcohol-based rubs and surgical disinfectants. Chlorhexidine’s role in surgical prep and oral health, coupled with isopropyl alcohol’s ubiquity in hand sanitizers, has seen sustained growth. Furthermore, increasing hospital-acquired infection (HAI) protocols solidify demand [3].

Stringent Infection Control Regulations

Regulatory agencies, including the FDA and EMA, mandate stringent antiseptic and disinfectant standards, propelling continuous innovation and adherence, thereby securing robust markets for chlorhexidine and isopropyl alcohol.

Expansion in Emerging Markets

Growth in healthcare infrastructure in Asia-Pacific, Latin America, and Africa fuels increased penetration of these disinfectants. Rising awareness and improved supply chains contribute to market expansion.

Consumer Hygiene Trends

An escalating consumer focus on personal and household hygiene is notably bolstered by urbanization and health consciousness, increasing retail sales of disinfectant products containing chlorhexidine and isopropyl alcohol.

Market Restraints and Challenges

Regulatory Challenges and Certification

Regulatory hurdles, including approval for new formulations and concentration standards, may impede rapid product deployment or reformulation initiatives, affecting market pace.

Environmental and Safety Concerns

Environmental impact assessments and safety issues, especially regarding waste disposal and skin sensitization, can result in stricter regulations or product reformulation, influencing profitability.

Competition and Price Erosion

Market saturation and commoditization of disinfectant products contribute to price pressures. Entry of generic manufacturers further compress margins.

Competitive Landscape

Leading players include McKesson, Reckitt Benckiser, Johnson & Johnson, 3M, and local manufacturers in emerging markets. Innovation focuses on alcohol-free formulations, formulations with enhanced residual activity, and environmentally friendly compounds. Strategic alliances, mergers, and acquisitions aim to expand product portfolios and geographic reach.

Financial Trajectory and Investment Outlook

Revenue Trends

Revenue growth for chlorhexidine is expected to be steady, driven by clinical use, with additional growth potential in oral care and consumer hygiene segments. The antimicrobial segment, particularly formulations with enhanced efficacy or unique delivery systems, offers premium pricing opportunities.

Isopropyl alcohol revenues benefit from current pandemic-fueled demand but face potential normalization post-pandemic. Nevertheless, steady long-term demand persists owing to industrial applications.

Profitability and Investment Opportunities

Profitable segments include specialized formulations, high-margin branded products, and R&D-driven innovations. Investment in biocompatible, environmentally sustainable, and novel delivery systems could yield competitive advantages.

Risks and Considerations

Market volatility stemming from geopolitical issues impacting supply chains, raw material prices (e.g., isopropyl alcohol feedstocks), and regulatory shifts may influence profitability. Companies focusing on diversification and innovation are better positioned to mitigate these risks.

Future Market Trends

• Innovation in Formulations: Development of long-acting antiseptics and alcohol-free disinfectants with comparable efficacy to traditional agents.
• Sustainability Focus: Eco-friendly production and biodegradable formulations to address environmental concerns.
• Digital and Smart Packaging: Incorporation of smart labels and digital tracking to enhance safety and compliance.
• Emerging Markets Growth: Expansion driven by infrastructure development, urbanization, and increasing healthcare expenditure.

Regulatory Environment Impact

The regulatory pathway’s complexity requires continuous monitoring. Approval processes for new formulations, safety standards, and environmental guidelines influence investment timelines and costs. Notably, the European Chemicals Agency’s registration requirements for biocidal products impact global supply strategies.

Conclusion

The market for chlorhexidine gluconate and isopropyl alcohol is poised for sustained growth, primarily driven by healthcare demands and consumer hygiene trends. While growth prospects are promising, stakeholders face challenges related to regulatory compliance, environmental concerns, and intense price competition. Strategic innovation, regulatory adaptation, and geographic expansion will be essential for companies to capitalize on current opportunities and navigate future uncertainties.

---

Key Takeaways

• The global disinfectant market, especially for chlorhexidine gluconate and isopropyl alcohol, is expected to grow at a CAGR of approximately 4-7% over the next decade.
• Healthcare initiatives post-pandemic and rising hygiene awareness are primary growth catalysts.
• Competition favors innovation, eco-friendly formulations, and strategic market expansion, particularly in emerging economies.
• Regulatory adherence and environmental sustainability are emerging market drivers impacting production and product acceptance.
• Investment opportunities lie in specialized formulations, high-margin branded products, and sustainable innovations, balanced against potential regulatory and supply chain risks.

---

FAQs

1. What are the primary end-use sectors for chlorhexidine gluconate and isopropyl alcohol?
Healthcare, personal hygiene, hospital disinfection, wound care, oral care, and industrial cleaning are primary sectors, with consumer retail also increasingly prominent.

2. How has the COVID-19 pandemic influenced the market outlook for these disinfectants?
The pandemic significantly boosted demand, especially for alcohol-based products, leading to increased production, innovation, and supply chain stabilization efforts. Post-pandemic, demand remains elevated due to heightened hygiene consciousness.

3. What are key regulatory concerns impacting the market?
Regulatory agencies focus on safety profiles, environmental impact, and formulation standards. Approval processes for new formulations and compliance with biocidal product regulations are critical considerations.

4. Which regions are expected to see the fastest growth?
Emerging economies in Asia-Pacific, Latin America, and Africa are anticipated to experience faster growth driven by healthcare infrastructure development and rising hygiene awareness.

5. What are potential future innovations within this market?
Sustainable formulations, alcohol-free disinfectants, long-lasting antiseptics, and smart packaging solutions are anticipated technological advancements shaping future growth.

---

Sources:
[1] MarketResearchForecasts. (2023). Global Chlorhexidine Market Outlook.
[2] Grand View Research. (2023). Isopropyl Alcohol Market Size & Trends.
[3] World Health Organization. (2022). Infection Prevention and Control.