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SOLUPREP S Drug Patent Profile

When do Soluprep S patents expire, and what generic alternatives are available?

Soluprep S is a drug marketed by 3m Health Care and is included in one NDA.

The generic ingredient in SOLUPREP S is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.

Summary for SOLUPREP S

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	SOLUPREP S at DailyMed

Recent Clinical Trials for SOLUPREP S

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

Sponsor	Phase
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4
Claire Bourgeois	Phase 4
Fédération des médecins résidents du Québec	Phase 4

See all SOLUPREP S clinical trials

Pharmacology for SOLUPREP S

Physiological Effect

Decreased Cell Wall Integrity

US Patents and Regulatory Information for SOLUPREP S

SOLUPREP S is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
3m Health Care	SOLUPREP S	chlorhexidine gluconate; isopropyl alcohol	SOLUTION;TOPICAL	208288-001	Aug 8, 2018		OTC	Yes	Yes

International Patents for SOLUPREP S

See the table below for patents covering SOLUPREP S around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2711217	COMPOSITIONS ANTIMICROBIENNES (ANTIMICROBIAL COMPOSITIONS)
Australia	2008347253	Antimicrobial compositions
China	107019686	抗微生物组合物 (Antimicrobial compositions)
World Intellectual Property Organization (WIPO)	2009088894
Brazil	PI0819567	"composições antimicrobianas, método para aprimorar a adesão molhada do artigo adesivo médico e método para evitar ou tratar uma condição da pele de um mamífero
China	101951779	Antimicrobial compositions

SOLUPREP S Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SoluPrep S

Introduction to SoluPrep S

SoluPrep S, a product of 3M, is a sterile antiseptic solution designed for patient preoperative skin preparation. It contains a dual active formulation of chlorhexidine gluconate (2% w/v) and isopropyl alcohol (70% v/v), which provides robust antimicrobial protection against a broad spectrum of bacteria, including gram-positive and gram-negative bacteria, multi-drug resistant organisms (MDROs), and yeast[5].

Market Context: Global Antiseptic Market

The global antiseptic market, within which SoluPrep S operates, is projected to experience significant growth. By 2031, the market is expected to reach USD 8.80 billion, growing at a CAGR of 8.1% from 2024 to 2031. This growth is driven by increasing healthcare expenditure, rising awareness about healthcare-associated infections (HAIs), and a growing geriatric population prone to infections[4].

Segmentation and Market Share

SoluPrep S falls under the skin antiseptic segment, which is a crucial part of the broader antiseptic market. The skin antiseptic market itself is expected to reach USD 2.5 billion by 2029, growing at a CAGR of 7.4% from 2023 to 2029. The solution segment, which includes products like SoluPrep S, is anticipated to acquire a significant market share, with a projected market value of $1.1 billion by 2029[1].

Regional Outlook

Geographically, the North American market currently dominates the antiseptic market due to its well-established healthcare infrastructure and high healthcare spending. However, the Asia Pacific region is emerging as a highly lucrative market, driven by rising healthcare standards, growing medical tourism, and increasing healthcare investments in countries like India and China. This regional growth is likely to benefit products like SoluPrep S, which are in high demand for surgical preparations[4].

Key Drivers

Several factors drive the demand for SoluPrep S and similar antiseptic solutions:

• Increasing Healthcare Expenditure: Rising healthcare spending in both public and private sectors is a significant driver. As healthcare systems invest more in infection control measures, the demand for effective antiseptics like SoluPrep S increases[1][4].
• Growing Awareness of HAIs: The rising awareness about healthcare-associated infections and the need for stringent infection control protocols further boost the demand for antiseptic solutions[4].
• Geriatric Population: The growing geriatric population, which is more susceptible to infections, also contributes to the increasing demand for antiseptics[4].

Product Features and Competitive Advantage

SoluPrep S offers several unique features that contribute to its market success:

• Dual Active Formulation: The combination of chlorhexidine gluconate and isopropyl alcohol provides broad-spectrum antimicrobial protection.
• Antimicrobial Persistence: SoluPrep S offers at least 96 hours of antimicrobial persistence, which is crucial for protecting patients during the wound healing process[5].
• Visibility and Adherence: The solution is visible on various skin tones and contains an ingredient that improves surgical drape adherence[5].

Financial Trajectory

Given the growth projections of the global antiseptic market and the skin antiseptic segment, SoluPrep S is likely to see a positive financial trajectory:

• Market Size: As the skin antiseptic market grows to USD 2.5 billion by 2029, products like SoluPrep S are expected to capture a significant share of this market.
• Revenue Growth: With a CAGR of 7.4% in the skin antiseptic market, SoluPrep S can anticipate steady revenue growth over the forecast period[1].

Challenges and Restraints

While SoluPrep S and the broader antiseptic market face several growth drivers, there are also some challenges:

• Regulatory Concerns: Stringent regulations regarding the use of antiseptic ingredients can slow market expansion. Ensuring compliance with these regulations is crucial for maintaining market presence[4].
• Price Sensitivity: In regions like Asia Pacific, price sensitivity can impact sales volumes. Local manufacturers offering cost-effective alternatives can pose competition to premium products like SoluPrep S[4].

Key Players and Competitive Landscape

SoluPrep S competes in a market with several key players, including:

• 3M Company: The manufacturer of SoluPrep S, known for its innovative healthcare solutions.
• Other Major Players: Companies like Becton, Dickinson and Company, B. Braun Melsungen AG, Cardinal Health, Inc., and Ecolab, Inc. also operate in the antiseptic market[1].

Conclusion

SoluPrep S operates in a dynamic and growing market driven by increasing healthcare expenditure, rising awareness of HAIs, and a growing geriatric population. With its unique features and FDA approval, SoluPrep S is well-positioned to capture a significant share of the expanding skin antiseptic market.

Key Takeaways

• The global antiseptic market is projected to reach USD 8.80 billion by 2031.
• The skin antiseptic market, where SoluPrep S operates, is expected to reach USD 2.5 billion by 2029.
• SoluPrep S offers a dual active formulation with 96 hours of antimicrobial persistence.
• The product benefits from growing healthcare expenditure and awareness about HAIs.
• Regulatory concerns and price sensitivity are key challenges.

Frequently Asked Questions

1. What is the expected growth rate of the skin antiseptic market?

The skin antiseptic market is expected to grow at a CAGR of 7.4% from 2023 to 2029[1].

2. What are the key drivers of the antiseptic market?

Key drivers include increasing healthcare expenditure, growing awareness of HAIs, and a growing geriatric population[1][4].

3. What unique features does SoluPrep S offer?

SoluPrep S offers a dual active formulation of chlorhexidine gluconate and isopropyl alcohol, providing broad-spectrum antimicrobial protection and at least 96 hours of antimicrobial persistence[5].

4. Which regions are expected to drive the growth of the antiseptic market?

North America currently dominates, but the Asia Pacific region is expected to emerge as the most lucrative market due to rising healthcare standards and growing medical tourism[4].

5. What are the potential challenges for SoluPrep S in the market?

Challenges include stringent regulations regarding antiseptic ingredients and price sensitivity in regions like Asia Pacific[4].

Cited Sources

1. KBV Research: Skin Antiseptic Market Size & Industry Trends Report to 2029.
2. Drugs.com: SoluPrep S: Package Insert / Prescribing Information.
3. CITIline: FY 2018 PDUFA Performance Report.
4. Coherent Market Insights: Antiseptic Market - Share, Size and Industry Analysis.
5. Solventum: 3M™ SoluPrep™ S Sterile Antiseptic Solution 2% CHG / 70% IPA.