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Last Updated: December 22, 2024

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - Generic Drug Details


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What are the generic drug sources for bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride and what is the scope of patent protection?

Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride is the generic ingredient in two branded drugs marketed by Braintree and Novel Labs Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

US Patents and Regulatory Information for BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Braintree HALFLYTELY bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 021551-003 Jul 16, 2010 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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

Expired US Patents for BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Braintree HALFLYTELY bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL 021551-003 Jul 16, 2010 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride

Introduction

The combination of bisacodyl, polyethylene glycol 3350 (PEG-3350), potassium chloride, sodium bicarbonate, and sodium chloride is a widely used bowel preparation solution, particularly for colonoscopy procedures. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Overview

The bowel preparation market is driven by the increasing demand for colonoscopy procedures, which are essential for the early detection and prevention of colorectal cancer. The market is characterized by a mix of prescription and over-the-counter (OTC) products, with the combination of bisacodyl and PEG-3350 being a significant player.

Key Components and Their Roles

  • Bisacodyl: A contact stimulant laxative that helps induce bowel movements.
  • Polyethylene Glycol 3350 (PEG-3350): An osmotic laxative that retains water in the colon to produce a watery stool[1][4][5].
  • Potassium Chloride, Sodium Bicarbonate, and Sodium Chloride: Electrolytes that help maintain the balance of fluids and electrolytes during the bowel cleansing process.

Market Segmentation

The market can be segmented based on the type of product (prescription vs. OTC), the type of procedure (colonoscopy, other gastrointestinal procedures), and the geographic region.

Prescription vs. OTC

The combination of bisacodyl and PEG-3350 is available in both prescription and OTC forms. Prescription forms are often used for more complex bowel preparation needs, while OTC forms are used for routine cleansing.

Type of Procedure

The primary use of this combination is for colonoscopy preparations. However, it can also be used for other gastrointestinal procedures that require thorough bowel cleansing.

Geographic Region

The demand for bowel preparation solutions varies by region, with developed countries having a higher incidence of colonoscopy procedures due to better healthcare infrastructure and higher awareness of preventive care.

Competitive Landscape

The competitive landscape includes various bowel preparation solutions, some of which are:

  • HalfLytely and Bisacodyl Tablets Bowel Prep Kit: This kit combines PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride with bisacodyl delayed-release tablets[4].
  • MiraLAX (PEG-3350): A standalone osmotic laxative that is also widely used for bowel cleansing[3].

Financial Performance

The financial performance of the bowel preparation market, including the combination of bisacodyl and PEG-3350, is influenced by several factors:

Revenue Growth

The market has seen steady revenue growth due to the increasing number of colonoscopy procedures. According to industry reports, the global bowel preparation market is expected to continue growing as more people undergo preventive screenings.

Cost and Pricing

The cost of the combination product is generally competitive with other bowel preparation solutions. The pricing strategy often involves discounts for bulk purchases and rebates for patients, which can impact the overall revenue.

Insurance Coverage

Insurance coverage plays a significant role in the financial trajectory. Many health insurance plans cover the cost of bowel preparation solutions, making them more accessible to patients.

Regulatory Environment

The regulatory environment is crucial for the financial health of pharmaceutical products. The FDA's guidelines and approvals significantly impact the market dynamics.

FDA Approvals and Guidelines

Products like HalfLytely and Bisacodyl Tablets Bowel Prep Kit must comply with FDA regulations, including bioequivalence studies and dissolution testing[2][4].

Consumer Preferences and Satisfaction

Consumer satisfaction and preferences also influence the market dynamics. For instance:

  • User Reviews: Products like MiraLAX and the bisacodyl-PEG-3350 combination have mixed reviews, with some users reporting positive effects and others reporting negative side effects[3].

Side Effects and Safety Concerns

The safety profile of the combination product is a critical factor in its market success. Common side effects include diarrhea, nausea, and electrolyte imbalances. In pediatric patients, there are specific concerns such as hypoglycemia and dehydration[1].

Clinical Efficacy

The clinical efficacy of the combination product is well-documented. It effectively cleanses the bowel, usually within four hours, making it a preferred choice for colonoscopy preparations[1][4].

Future Outlook

The future outlook for the bowel preparation market, including the bisacodyl-PEG-3350 combination, is positive due to several factors:

  • Increasing Demand for Preventive Care: As awareness of preventive care increases, the demand for colonoscopy procedures and associated bowel preparation solutions is expected to rise.
  • Advancements in Formulations: Continuous improvements in formulations, such as the addition of flavoring ingredients and better electrolyte balance, can enhance patient compliance and satisfaction.
  • Expanding Market Reach: The market is expected to expand into emerging economies where healthcare infrastructure is improving.

Key Takeaways

  • The combination of bisacodyl, PEG-3350, potassium chloride, sodium bicarbonate, and sodium chloride is a significant player in the bowel preparation market.
  • The market is driven by the increasing demand for colonoscopy procedures and preventive care.
  • Regulatory compliance and consumer satisfaction are crucial for the financial trajectory of these products.
  • The future outlook is positive, with expected growth in demand and advancements in formulations.

FAQs

What is the primary use of the bisacodyl-PEG-3350 combination?

The primary use is for bowel cleansing prior to colonoscopy procedures.

What are the key components of this combination product?

The key components include bisacodyl, polyethylene glycol 3350 (PEG-3350), potassium chloride, sodium bicarbonate, and sodium chloride.

How does the combination product work?

The product works through the osmotic effect of PEG-3350, which retains water in the colon, and the stimulant effect of bisacodyl, which induces bowel movements.

What are the common side effects of this combination product?

Common side effects include diarrhea, nausea, and electrolyte imbalances.

Is the combination product available over-the-counter (OTC)?

Yes, the combination product is available in both prescription and OTC forms.

Cited Sources

  1. Drugs.com: PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride: Package Insert / Prescribing Info.
  2. FDA: Draft Guidance on Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride.
  3. Drugs.com: Bisacodyl / polyethylene glycol 3350 / potassium chloride / sodium bicarbonate / sodium chloride.
  4. FDA: HalfLytely and Bisacodyl Tablets Bowel Prep Kit.
  5. FDA: 203595Orig1s000 - accessdata.fda.gov.

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