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Last Updated: December 22, 2024

E-Z-EM PREP LYTE Drug Patent Profile


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When do E-z-em Prep Lyte patents expire, and when can generic versions of E-z-em Prep Lyte launch?

E-z-em Prep Lyte is a drug marketed by E Z Em and is included in one NDA.

The generic ingredient in E-Z-EM PREP LYTE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are four hundred and twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.

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Summary for E-Z-EM PREP LYTE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 168
DailyMed Link:E-Z-EM PREP LYTE at DailyMed
Drug patent expirations by year for E-Z-EM PREP LYTE

US Patents and Regulatory Information for E-Z-EM PREP LYTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
E Z Em E-Z-EM PREP LYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SUSPENSION;ORAL 071278-001 Nov 21, 1988 DISCN No No ⤷  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

E-Z-EM PREP LYTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for E-Z-EM PREP LYTE

Introduction

E-Z-EM PREP LYTE, a bowel preparation solution, is a critical component in the gastrointestinal endoscopy market, particularly for procedures like colonoscopy. Understanding the market dynamics and financial trajectory of this product is essential for stakeholders, including healthcare providers, investors, and patients.

Market Overview

The market for bowel preparation solutions is driven by the increasing demand for colonoscopies, which are essential for the early detection and prevention of colorectal cancer. The ideal bowel preparation should effectively clear the colon of fecal material, ensuring accurate diagnostic results.

Product Profile: E-Z-EM PREP LYTE

E-Z-EM PREP LYTE is a polyethylene glycol electrolyte solution (PEG-ELS) designed to prepare the colon for procedures like colonoscopy. Here are some key characteristics:

Composition

  • It contains polyethylene glycol, sodium sulfate, sodium bicarbonate, sodium chloride, and potassium chloride, which help in effectively cleansing the colon[4].

FDA Approval

  • E-Z-EM PREP LYTE is FDA-approved, ensuring it meets stringent safety and efficacy standards[1].

Usage

  • The solution is typically administered in a split dose, with the patient consuming half the solution the evening before the procedure and the remaining half in the morning[4].

Market Dynamics

Competitive Landscape

The bowel preparation market is competitive, with several products available, including GoLYTELY, NuLYTELY, Trilyte, and Moviprep. Each product has its own set of advantages and disadvantages, such as palatability, cost, and potential side effects[1].

Patient Preferences

Patient compliance is a significant factor in the success of bowel preparation. Solutions that are more palatable and easier to consume tend to have higher compliance rates. E-Z-EM PREP LYTE, while effective, may not be the most palatable option compared to some other preparations[1].

Clinical Efficacy

Studies have shown that E-Z-EM PREP LYTE is effective in cleansing the colon, although it may have some drawbacks, such as the potential for electrolyte imbalances and lower patient tolerance compared to low-volume preparations[4].

Financial Trajectory

Revenue Performance

E-Z-EM, the company behind PREP LYTE, has historically reported significant revenues from its gastrointestinal products. For instance, in 2007, E-Z-EM posted record fiscal-year revenues, with earnings from continuing operations rising to $2.8 million[5].

Market Share

While specific financial data for E-Z-EM PREP LYTE is not readily available, the product's market share can be inferred from the overall performance of E-Z-EM's gastrointestinal segment. The company's strong presence in the market and the demand for effective bowel preparation solutions contribute to its financial stability.

Cost and Pricing

The average wholesale price of E-Z-EM PREP LYTE is around $24.56, which is competitive with other PEG-ELS solutions on the market. The pricing strategy is crucial as it affects both the company's revenue and patient access to the product[1].

Regulatory and Safety Considerations

FDA Guidelines

E-Z-EM PREP LYTE must adhere to FDA guidelines, which include ensuring the product does not cause significant electrolyte imbalances or other adverse effects. The FDA approval process is stringent, and any changes in the formulation or usage must be approved[1].

Safety Profile

The safety profile of E-Z-EM PREP LYTE includes potential side effects such as hyponatremia and electrolyte imbalances. However, these are generally manageable with proper medical supervision[4].

Future Outlook

Market Growth

The demand for bowel preparation solutions is expected to grow due to increasing awareness and screening for colorectal cancer. This growth will likely benefit E-Z-EM PREP LYTE and other similar products.

Innovation and Competition

The market is likely to see innovations in bowel preparation solutions, such as more palatable and low-volume options. E-Z-EM will need to adapt to these changes to maintain its market share.

Key Takeaways

  • Market Demand: The demand for effective bowel preparation solutions like E-Z-EM PREP LYTE is driven by the need for accurate colonoscopy results.
  • Competitive Landscape: The market is competitive, with several products available, each with its own advantages and disadvantages.
  • Financial Performance: E-Z-EM has historically reported strong revenues from its gastrointestinal products, including PREP LYTE.
  • Regulatory Compliance: The product must adhere to FDA guidelines to ensure safety and efficacy.
  • Future Outlook: The market is expected to grow, with a need for continuous innovation to stay competitive.

FAQs

  1. What is E-Z-EM PREP LYTE used for?

    • E-Z-EM PREP LYTE is used as a bowel preparation solution to cleanse the colon before procedures like colonoscopy.
  2. Is E-Z-EM PREP LYTE FDA-approved?

    • Yes, E-Z-EM PREP LYTE is FDA-approved, ensuring it meets safety and efficacy standards.
  3. How is E-Z-EM PREP LYTE administered?

    • It is typically administered in a split dose, with half the solution consumed the evening before the procedure and the remaining half in the morning.
  4. What are the potential side effects of E-Z-EM PREP LYTE?

    • Potential side effects include electrolyte imbalances and hyponatremia, although these are generally manageable with proper medical supervision.
  5. How does E-Z-EM PREP LYTE compare to other bowel preparation solutions?

    • E-Z-EM PREP LYTE is effective but may not be as palatable as some other preparations. It is competitively priced and has a strong market presence.

Sources

  1. Gastrointestinal Endoscopy - Bowel preparation before colonoscopy[1].
  2. IDEXX Investor Day 2024 - This source was not directly relevant to E-Z-EM PREP LYTE but provided context on the broader healthcare diagnostics market[2].
  3. The economics of follow-on drug research and development - This study was not directly relevant to E-Z-EM PREP LYTE but provided insights into pharmaceutical market dynamics[3].
  4. Gastrointestinal Endoscopy - Bowel preparation before colonoscopy (PDF)[4].
  5. AuntMinnie - E-Z-EM posts record fiscal-year revenues[5].

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