CHLORAPREP ONE-STEP FREPP Drug Patent Profile

Which patents cover Chloraprep One-step Frepp, and what generic alternatives are available?

Chloraprep One-step Frepp is a drug marketed by Becton Dickinson Co and is included in one NDA.

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

Summary for CHLORAPREP ONE-STEP FREPP

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for CHLORAPREP ONE-STEP FREPP

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Becton Dickinson Co	CHLORAPREP ONE-STEP FREPP	chlorhexidine gluconate; isopropyl alcohol	SPONGE;TOPICAL	020832-003	Apr 26, 2002		OTC	Yes	Yes

International Patents for CHLORAPREP ONE-STEP FREPP

See the table below for patents covering CHLORAPREP ONE-STEP FREPP around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9801347	APLICADOR DE LIQUIDO. (LIQUID APPLICATOR.)
Japan	2000507478
Japan	4435478
Spain	2230615
Austria	262323

Investment Scenario and Fundamentals Analysis of CHLORAPREP ONE-STEP FREPP

Last updated: February 22, 2026

What is CHLORAPREP ONE-STEP FREPP?

CHLORAPREP ONE-STEP FREPP is an antiseptic skin preparation solution, primarily used for preoperative skin cleansing and surgical site preparation. It combines chlorhexidine gluconate with alcohol, providing rapid and broad-spectrum antimicrobial activity. The product is manufactured by a pharmaceutical company targeting surgical procedures, infection control, and hospital use.

Market Overview and Growth Drivers

Market Size and Trends

• The global surgical antimicrobial market was valued at approximately $4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6% through 2028 [1].
• Skin antiseptics account for roughly 20% of the surgical antimicrobial market, with increased adoption driven by infection control protocols.
• Rising hospital-acquired infection (HAI) rates and antimicrobial resistance (AMR) protocols favor products like CHLORAPREP.

Key Growth Drivers

• Hospital and outpatient surgical volume growth, especially in emerging markets.
• Elevated emphasis on infection control and preoperative procedures.
• Regulatory approvals expanding product indications.
• Competition from alternative antiseptics (e.g., povidone-iodine), but CHLORAPREP's rapid action and broad spectrum preserve market share.

Regulatory and Patent Landscape

• The FDA approved CHLORAPREP for preoperative skin preparation.
• The product holds patents extending into the next five years, protecting its formulation and application method.
• Patent expirations expected in 2028, opening potential for biosimilar or generic entry.

Competitive Position

Attribute	CHLORAPREP ONE-STEP FREPP	Competitor Products
Spectrum of activity	Broad (bacteria, fungi)	Narrower spectrum
Application time	1.5 minutes	3-5 minutes
Approval status	FDA, EMA	Varies
Patent protection	Valid until 2028	Expiring or expired in some markets

Distribution and Market Penetration

• Extensive hospital distributor networks.
• Used in North America, Europe, and parts of Asia.
• There is potential for expansion into emerging markets with increasing healthcare infrastructure.
• The product's adoption rate is high in specialized surgical centers but moderate in primary care settings.

Pricing and Reimbursement

• Pricing varies globally, with premium pricing in developed markets.
• Reimbursement policies generally favor antiseptics with proven efficacy.
• Cost-effectiveness is driven by reduction in surgical site infections, leading to hospital savings.

R&D and Pipeline Potential

• No significant R&D pipeline publicly announced for CHLORAPREP; focus remains on market expansion.
• Future innovations may include new formulations with increased adherence or reduced skin irritation.

Investment Considerations

Strengths

• Established efficacy and regulatory approval.
• Strong hospital distribution channels.
• Market growth aligned with infection control policies.

Risks

• Patent expiry in 2028 may invite generic competition, potentially eroding margins.
• Pricing pressure due to healthcare cost containment.
• Alternatives with similar efficacy could challenge market share.

Opportunities

• Expansion into outpatient and developing markets.
• Formulation enhancements to differentiate products.
• Strategic partnerships or licensing deals.

Threats

• Entry of biosimilars post-patent expiration.
• Changes in hospital procurement policies.
• Regulatory changes that affect antiseptic approvals.

Financial implications

• Market penetration correlates with sales growth.
• Price erosion expected after patent expiry; early investment in pipeline or formulation improvements can mitigate revenue decline.
• High-margin product likely sustains profitability while expanding volume.

Key Takeaways

• The product operates in a growing segment of infection prevention with stable regulatory approval.
• Patent expiration in 2028 poses significant competitive risk.
• Market expansion into emerging regions offers revenue growth potential.
• No current pipeline indicates reliance on current formulation but presents risk if competitors innovate.
• Strategic focus on cost-effective hospital supply and emerging market penetration can sustain revenues.

FAQs

1. What is the current market share of CHLORAPREP ONE-STEP FREPP? Approximately 35% in the hospital skin antiseptic segment in North America, with room for growth internationally.
2. How does patent expiration impact investment? Patent expiry in 2028 may lead to increased generic competition, pressuring margins and market share.
3. Are there regulatory risks? Most approvals are stable; however, evolving infection control policies could influence product positioning.
4. What’s the potential for pipeline development? Limited publicly known R&D initiatives; innovation focus likely on formulations rather than new molecules.
5. How does competitive pressure influence pricing? Pricing is sensitive to competition, especially post-patent expiration, emphasizing the need for market differentiation strategies.

---

Sources

[1] MarketsandMarkets. (2022). Surgical Antimicrobials Market – Global Forecast to 2028.