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Last Updated: December 22, 2024

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL Drug Patent Profile


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Which patents cover Peg-3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl, and what generic alternatives are available?

Peg-3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride And Bisacodyl is a drug marketed by Novel Labs Inc and is included in one NDA.

The generic ingredient in PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL is bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride profile page.

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Summary for PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
Drug patent expirations by year for PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

US Patents and Regulatory Information for PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 202217-001 Aug 20, 2014 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

PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PEG-3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride, and Bisacodyl

Introduction to PEG-3350 and Associated Components

Polyethylene glycol 3350 (PEG-3350), often combined with sodium chloride, sodium bicarbonate, and potassium chloride, is a widely used formulation for bowel cleansing and constipation relief. This combination, sometimes including bisacodyl, plays a crucial role in various medical applications.

Market Drivers

Growing Demand for Medicines

The increasing demand for medicines, particularly those requiring advanced drug delivery systems, significantly drives the market for PEG-3350 and its associated components. PEG's properties, such as solubility, non-toxicity, and the ability to enhance drug absorption rates, make it essential in pharmaceutical applications[1].

Chronic Diseases and Aging Population

The rising prevalence of chronic diseases like cancer, diabetes, and cardiovascular diseases, exacerbated by an aging global population, has created a need for efficient and advanced treatments. PEG's role in improving the solubility, bioavailability, and stability of drug formulations is critical in this context[1].

Personalized Medicines and Biologics

The growth in personalized medicines and biologics has increased the focus on drug delivery systems, further fueling the demand for PEG. PEGylation technology, which modifies drugs to enhance their pharmacokinetic properties, is also a significant driver[1].

Market Size and Growth Projections

Global Market Value

The global macrogol/polyethylene glycol (PEG) market was valued at USD 5667.81 million in 2021 and is expected to reach USD 10,074.39 million by 2030, growing at a CAGR of 6.68%[4].

Segment Growth

The PEG-3350 segment, specifically, is projected to increase at a CAGR of 5.8% during the forecast period. This growth is driven by its use in short-term and long-term relief of constipation, as well as in treating constipation associated with various medical conditions[4].

Regional Market Dynamics

Asia Pacific Region

The Asia Pacific region is the fastest-growing market for PEG due to rapid industrial growth, increasing investments in healthcare, and rising demand across various end-use industries. Countries like India and China are driving this growth with their expanding pharmaceutical and healthcare industries[1].

Clinical Applications and Efficacy

Bowel Cleansing

PEG-3350, combined with sodium chloride, sodium bicarbonate, and potassium chloride, is commonly used for bowel cleansing prior to colonoscopy. This formulation is effective in achieving 'successful' and 'excellent' bowel cleansing, with studies showing comparable or superior outcomes to other bowel cleansers[5].

Constipation Relief

PEG-3350 is also used for the relief of chronic constipation, improving stool frequency and consistency. It is particularly useful in treating constipation caused by various factors, including pharmaceutical drugs and neurological conditions like multiple sclerosis and Parkinson’s disease[4].

Safety and Adverse Reactions

Common Adverse Reactions

The most common adverse reactions to PEG-3350 formulations include nausea, abdominal fullness, bloating, abdominal cramps, vomiting, and anal irritation. These reactions are generally transient and subside rapidly[2].

Special Populations

In clinical trials, the safety and effectiveness of PEG-3350 formulations have been evaluated in various populations, including the elderly and those at risk for fluid and electrolyte abnormalities. No significant differences in safety or effectiveness were observed in these groups compared to younger subjects[5].

Competitive Landscape

Market Share and Prescription Trends

The market for PEG-3350 products is competitive, with various brands and generic equivalents. For instance, MiraLAX and its generic equivalents accounted for the largest proportion of dispensed prescriptions in 2011, followed by other products like Moviprep and HalfLytely[3].

Regulatory and Approval Aspects

FDA Approvals and Exclusivity

Products like SUCLEAR, which include PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride, have been approved by the FDA. The exclusivity periods for these products and their competitors play a significant role in market dynamics[5].

Financial Impact and Cost Considerations

Cost of Bowel Preparations

The cost of bowel preparations is relatively small compared to the cost of repeat colonoscopies due to inadequate cleansing. This economic factor influences the choice of bowel preparation products and contributes to the market growth of PEG-3350 formulations[5].

Key Takeaways

  • The global PEG market is driven by growing demand for medicines, particularly those requiring advanced drug delivery systems.
  • PEG-3350 is crucial in pharmaceutical applications due to its solubility, non-toxicity, and ability to enhance drug absorption.
  • The Asia Pacific region is the fastest-growing market due to rapid industrial and healthcare growth.
  • PEG-3350 formulations are effective in bowel cleansing and constipation relief, with a favorable safety profile.
  • The market is competitive, with various brands and generic equivalents, and is influenced by regulatory approvals and exclusivity periods.

FAQs

1. What is the primary use of PEG-3350 in medical applications?

PEG-3350 is primarily used for bowel cleansing prior to colonoscopy and for the relief of chronic constipation.

2. How does PEG-3350 enhance drug formulations?

PEG-3350 enhances drug formulations by improving solubility, bioavailability, and stability, making it crucial for manufacturing oral, topical, and injectable medicines.

3. What are the common adverse reactions to PEG-3350 formulations?

Common adverse reactions include nausea, abdominal fullness, bloating, abdominal cramps, vomiting, and anal irritation.

4. Which region is the fastest-growing market for PEG?

The Asia Pacific region is the fastest-growing market for PEG due to rapid industrial growth and increasing investments in healthcare.

5. What is the projected growth rate of the global PEG market?

The global PEG market is expected to grow at a CAGR of 6.68% from 2021 to 2030.

Sources:

  1. MarketsandMarkets - Polyethylene Glycol Market, Industry Size Forecast Report [Latest]
  2. Drugs.com - PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride
  3. FDA - 203595Orig1s000 - accessdata.fda.gov
  4. Biospace - Macrogol/Polyethylene Glycol (PEG) Market Growth 2022-2030
  5. PBM VA - PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride Monograph

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