HIBICLENS Drug Patent Profile

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

Hibiclens is a drug marketed by Molnlycke Hlth and is included in two NDAs.

The generic ingredient in HIBICLENS 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 Hibiclens

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

Summary for HIBICLENS

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	15
Patent Applications:	7,385
Drug Sales Revenues:	Drug sales revenues for HIBICLENS
What excipients (inactive ingredients) are in HIBICLENS?	HIBICLENS excipients list
DailyMed Link:	HIBICLENS at DailyMed

See drug sales revenues for HIBICLENS

Recent Clinical Trials for HIBICLENS

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

Sponsor	Phase
Yaneve Fonge	Phase 4
University of Missouri-Columbia	Phase 4
Carilion Clinic	Phase 4

See all HIBICLENS clinical trials

Pharmacology for HIBICLENS

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for HIBICLENS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982		OTC	Yes	Yes
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for HIBICLENS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982	3,960,745
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982	3,855,140
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982	3,886,277
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SPONGE;TOPICAL	018423-001	Approved Prior to Jan 1, 1982	3,855,140
Molnlycke Hlth	HIBICLENS	chlorhexidine gluconate	SOLUTION;TOPICAL	017768-001	Approved Prior to Jan 1, 1982	3,960,745

International Patents for HIBICLENS

See the table below for patents covering HIBICLENS around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	39535	ANTIBACTERIAL CLEANSING COMPOSITION COMPRISING CHLORHEXIDINE
Belgium	785049
Sweden	410616	RENGORINGSKOMPOSITION INNEHALLANDE ETT KLORHEXIDINSALT OCH ETT POLYOXIETYLEN/POLYOXIPROPYLENSEGMENTPOLYMERISAT
Netherlands	167852
Netherlands	6801267
Austria	297940
Canada	969442	CLEANSING COMPOSITIONS

HIBICLENS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Chlorhexidine Gluconate (CHG) Products

Introduction to Chlorhexidine Gluconate (CHG)

Chlorhexidine gluconate (CHG) is a widely used antiseptic and antibacterial agent, often marketed under brand names like HIBICLENS. It is crucial in various healthcare settings for infection prevention and wound care.

Market Size and Growth

The global market for CHG products, including wipes, solutions, and dressings, is experiencing significant growth. Here are some key statistics:

• CHG Wipes Market: Expected to grow to $61.46 billion by 2028 at a CAGR of 5.3%, driven by pandemic-driven hygiene measures, an increasing elderly population, and global expansion of healthcare facilities[1].
• CHG Solution Market: Valued at $181.3 million in 2022, with a projected CAGR of 1.90% during the forecast period[3].
• CHG Dressing Market: Projected to reach $1.5 billion by 2033, growing at a CAGR of 4.4% from 2023 to 2033[4].

Drivers of Market Growth

Several factors are driving the growth of the CHG market:

Infection Control and Prevention

Healthcare-associated infections (HAIs) are a significant concern, with 1 in 25 hospitalized patients having an HAI. CHG products have been shown to reduce the incidence of HAIs, such as Clostridium difficile and methicillin-resistant Staphylococcus aureus (MRSA), leading to substantial cost savings for hospitals[2].

Aging Population

The growing geriatric population, particularly in regions like North America and Asia-Pacific, is increasing the demand for healthcare services, including infection prevention and wound care products[1][3].

Government Initiatives and Regulations

Government initiatives and clinical recommendations, such as those from the Centers for Disease Control and Prevention (CDC) and the National Institute for Health and Care Excellence (NICE), advocate for the use of CHG products in healthcare settings, boosting market demand[4].

Technological Innovations

Innovations in product formulations, packaging designs, and textures are enhancing the efficacy and user experience of CHG products. For example, environmentally friendly formulations and telemedicine integration are emerging trends[1].

Regional Analysis

The market for CHG products is geographically diverse:

• North America: Currently the largest market for CHG wipes and solutions, driven by excellent healthcare facilities and high healthcare spending[1][3].
• Asia-Pacific: Expected to be the fastest-growing region due to a growing geriatric population and increasing focus on healthcare systems in countries like India and China[1][3].
• Europe: Western Europe is a significant market, with countries like the UK following clinical guidelines that recommend the use of CHG dressings for specific types of wounds[4].

Financial Impact

The financial benefits of using CHG products are substantial:

• Cost Savings: Implementing CHG bathing protocols can result in significant cost savings by reducing the incidence of HAIs. For instance, a hospital saved nearly $114,000 annually by reducing HAIs through the use of CHG bathing solutions[2].
• Market Revenue: The revenue growth of CHG products is driven by their widespread adoption in healthcare settings. The CHG wipes market alone is expected to reach $61.46 billion by 2028[1].

Competitive Landscape

The market for CHG products is competitive, with several key players:

• Mergers and Acquisitions: Companies like Schülke & Mayr GmbH are expanding their product portfolios through acquisitions, such as the acquisition of Vesismin Health[1].
• Market Leaders: Companies like Johnson & Johnson and Avery Dennison Corporation are prominent in the CHG dressing market[4].

Challenges and Restraints

Despite the growth, there are challenges:

• Raw Material Volatility: Fluctuations in the prices of raw materials required for CHG solutions can restrain market growth[3].

Future Forecast

The future outlook for CHG products is positive:

• CHG Wipes: Expected to continue growing, driven by increasing consumer awareness and demand, as well as the expansion of healthcare facilities globally[1].
• CHG Solutions: Projected to grow at a CAGR of 1.90% from 2023 to 2032, driven by the rising number of surgical procedures[3].
• CHG Dressings: Forecast to reach $1.5 billion by 2033, with a CAGR of 4.4% from 2023 to 2033, driven by the need for infection prevention in surgical and wound care settings[4].

Key Takeaways

• The CHG market is driven by the need for infection control and prevention.
• Government initiatives and clinical recommendations play a crucial role in market growth.
• The market is expected to see significant growth across various regions.
• Financial benefits include substantial cost savings through reduced HAIs.
• The competitive landscape is marked by mergers and acquisitions, and key players are expanding their market presence.

FAQs

Q: What is the projected market size of the CHG wipes market by 2028? A: The CHG wipes market is expected to grow to $61.46 billion by 2028[1].

Q: How does the use of CHG products impact healthcare costs? A: The use of CHG products can significantly reduce healthcare costs by preventing HAIs, which can save hospitals substantial amounts annually[2].

Q: Which region is expected to be the fastest-growing for CHG wipes? A: The Asia-Pacific region is expected to be the fastest-growing for CHG wipes[1].

Q: What are the key drivers of the CHG solution market? A: The key drivers include the rising number of surgical procedures and the growing geriatric population[3].

Q: Which companies are prominent in the CHG dressing market? A: Companies like Johnson & Johnson and Avery Dennison Corporation are key players in the CHG dressing market[4].

Cited Sources

1. The Business Research Company - Global Chlorhexidine Gluconate (CHG) Wipes Market Report 2024
2. AACN Advanced Critical Care - Chlorhexidine Gluconate Bathing Program to Reduce Health Care–Associated Infections
3. Emergen Research - Chlorhexidine Gluconate Solution Market Size
4. Future Market Insights - Chlorhexidine Gluconate Dressing Market Forecast 2033