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Last Updated: December 22, 2024

DURAPREP Drug Patent Profile


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Which patents cover Duraprep, and what generic alternatives are available?

Duraprep is a drug marketed by 3M and is included in one NDA.

The generic ingredient in DURAPREP is iodine povacrylex; isopropyl alcohol. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iodine povacrylex; isopropyl alcohol profile page.

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Summary for DURAPREP
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 9
DailyMed Link:DURAPREP at DailyMed
Drug patent expirations by year for DURAPREP
Recent Clinical Trials for DURAPREP

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

SponsorPhase
University of California, San DiegoPhase 4
University of Maryland, BaltimorePhase 4
McMaster UniversityPhase 4

See all DURAPREP clinical trials

US Patents and Regulatory Information for DURAPREP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m DURAPREP iodine povacrylex; isopropyl alcohol SPONGE;TOPICAL 021586-001 Sep 29, 2006 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
3m DURAPREP iodine povacrylex; isopropyl alcohol SPONGE;TOPICAL 021586-002 Sep 29, 2006 OTC Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DURAPREP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DuraPrep Surgical Solution

Introduction

DuraPrep Surgical Solution, introduced by 3M in 1987, is a non-aqueous iodophor containing 74% isopropyl alcohol, designed for preoperative skin preparation to reduce the risk of surgical site infections (SSIs). This article delves into the market dynamics and financial trajectory of DuraPrep, highlighting its cost-effectiveness, competitive positioning, and regulatory environment.

Market Context

The market for preoperative skin preparation solutions is highly competitive, with several key players including 3M's DuraPrep, Purdue-Frederick's Betadine, Regent Medical's Hibiclens, and Medi-Flex's ChloraPrep. Each product has its own strengths and weaknesses, influencing their market share and financial performance[4].

Cost-Effectiveness Analysis

A critical aspect of DuraPrep's market dynamics is its cost-effectiveness. A budget impact analysis (BIA) conducted by 3M demonstrated that DuraPrep Surgical Solution provided significant overall cost savings compared to other leading surgical prep products like povidone-iodine scrub paint (PI) and ChloraPrep.

  • Product Costs: While PI had the lowest product per unit cost at $1.71, DuraPrep was priced at $4.27 per unit, which is significantly lower than ChloraPrep's $7.08 per unit[1].
  • Preparation Time: DuraPrep required less preparation time compared to both PI and ChloraPrep, which are scrub-on applied products. This reduced surgical suite charges, contributing to overall cost savings[1].
  • SSI Reduction: The analysis showed that DuraPrep could save institutions over $100,000 in incremental costs from treating SSIs due to its effective reduction of SSI rates[1].

Competitive Positioning

DuraPrep's competitive edge is largely due to its balanced pricing and efficiency.

  • Efficiency in Application: As a paint-on application, DuraPrep is quicker to apply than scrub-on products like PI and ChloraPrep, reducing surgical time expenditures[1].
  • Efficacy: Studies have shown that chlorhexidine-based solutions, while more effective in reducing SSIs, are often more expensive. DuraPrep, as a mid-priced product, offers a balance between cost and efficacy[2].

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics of DuraPrep.

  • FDA Approval: DuraPrep, like other surgical prep solutions, must comply with FDA regulations. Products with new active agents or chlorhexidine must submit a New Drug Application (NDA) prior to marketing, ensuring strict safety and efficacy standards[4].
  • Labeling and Claims: Companies marketing under an NDA must adhere to strict labeling criteria, ensuring that any claims made about the product are supported by extensive testing and approval[4].

Financial Trajectory

The financial performance of DuraPrep is influenced by several factors, including its cost savings, market share, and the broader healthcare economic context.

  • Cost Savings: The BIA model indicated that institutions could save significant amounts by using DuraPrep, which translates into a positive financial trajectory for 3M. For example, the model suggested that DuraPrep could save an institution over $100,000 in incremental costs from treating SSIs[1].
  • Market Share: DuraPrep's competitive pricing and efficiency help it maintain a strong market share. The product's ability to reduce SSIs and associated costs makes it an attractive option for healthcare institutions looking to optimize their budgets[1].
  • Healthcare Economic Context: The rising costs of healthcare, particularly in procedures like lumbar fusion, highlight the importance of cost-effective solutions. DuraPrep's role in reducing these costs positions it favorably in the market[5].

Industry Expert Insights

Industry experts emphasize the importance of cost-effectiveness and efficacy in preoperative skin preparation solutions.

"The BIA model we created is simple for any institution to implement and can provide important insight for decision makers who need to optimize costs without sacrificing patient safety or quality," said Angie Carlson, PhD, lead researcher on the analysis[1].

Statistical Highlights

  • Cost Savings: Switching to chlorhexidine-based solutions from iodine can result in net cost savings of $16 to $26 per surgical case and up to $568,594 per year for a hospital[2].
  • SSI Reduction: Chlorhexidine antisepsis is associated with significantly fewer SSIs, with an adjusted risk ratio of 0.64 compared to iodine antisepsis[2].

Key Takeaways

  • Cost-Effectiveness: DuraPrep offers significant cost savings due to its efficient application and reduced SSI rates.
  • Competitive Positioning: DuraPrep balances pricing and efficacy, making it a preferred choice in the market.
  • Regulatory Compliance: Adherence to FDA regulations ensures the safety and efficacy of DuraPrep.
  • Financial Performance: DuraPrep's ability to reduce healthcare costs contributes positively to its financial trajectory.

FAQs

What is DuraPrep Surgical Solution?

DuraPrep Surgical Solution is a non-aqueous iodophor containing 74% isopropyl alcohol, used for preoperative skin preparation to reduce the risk of surgical site infections.

How does DuraPrep compare to other surgical prep products in terms of cost?

DuraPrep is priced at $4.27 per unit, which is lower than ChloraPrep ($7.08) but higher than povidone-iodine scrub paint ($1.71). However, DuraPrep's quicker application time reduces overall costs.

What are the key benefits of using DuraPrep?

DuraPrep offers significant cost savings, reduces surgical site infections, and has a quicker application time compared to scrub-on products.

Is DuraPrep FDA-approved?

Yes, DuraPrep complies with FDA regulations and has undergone extensive testing to ensure its safety and efficacy.

How does DuraPrep impact the financial trajectory of healthcare institutions?

DuraPrep can save institutions over $100,000 in incremental costs from treating SSIs, contributing to a positive financial trajectory by optimizing healthcare budgets.

Sources

  1. Budget Impact Analysis Shows that 3M™ DuraPrep™ Surgical Solution Provides Cost Savings Compared with Two Leading Surgical Prep Products. 3M News.
  2. Preoperative skin preparation: Topics by Science.gov.
  3. CE Credit Package 11 - Association of Surgical Technologists.
  4. The Great Surgical Prepping Debate - Outpatient Surgery Magazine.
  5. UCSF Techniques in Complex Spine Surgery Course. UCSF.

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