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Last Updated: December 12, 2025

COLYTE WITH FLAVOR PACKS Drug Patent Profile


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Which patents cover Colyte With Flavor Packs, and when can generic versions of Colyte With Flavor Packs launch?

Colyte With Flavor Packs is a drug marketed by Quagen and is included in one NDA.

The generic ingredient in COLYTE WITH FLAVOR PACKS 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 COLYTE WITH FLAVOR PACKS
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 6
DailyMed Link:COLYTE WITH FLAVOR PACKS at DailyMed
Drug patent expirations by year for COLYTE WITH FLAVOR PACKS
Recent Clinical Trials for COLYTE WITH FLAVOR PACKS

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

SponsorPhase
Incheon St.Mary's HospitalPhase 3
Seoul National University HospitalPhase 3
Inje UniversityN/A

See all COLYTE WITH FLAVOR PACKS clinical trials

US Patents and Regulatory Information for COLYTE WITH FLAVOR PACKS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quagen COLYTE WITH FLAVOR PACKS polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-012 Oct 8, 1998 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Colyte with Flavor Packs

Last updated: August 4, 2025

Introduction

The pharmaceutical landscape for bowel preparation solutions has seen significant evolution driven by patient preferences, technological innovations, and regulatory shifts. Colyte with Flavor Packs represents a notable entrant within this segment, offering a flavored, more palatable alternative to traditional polyethylene glycol (PEG)-based laxatives used in colonoscopy preparations. This article analyses the market dynamics influencing Colyte with Flavor Packs, evaluates its financial trajectory, and explores strategic implications for stakeholders.

Market Overview

The global colonoscopy preparation market is projected to reach approximately USD 2.8 billion by 2027, growing at a compound annual growth rate (CAGR) of around 5.2% [1]. This growth stems from increasing colorectal cancer screening awareness, aging populations, and advances in minimally invasive diagnostic procedures. Enhanced patient compliance—fostered by improved taste profiles—serves as a critical growth driver, positioning flavored preparations like Colyte as favorable options.

Colyte with Flavor Packs is produced by Braintree Laboratories, offering a PEG-based solution with added flavoring to improve palatability. Its introduction aligns with ongoing industry trends emphasizing patient comfort and adherence, critical factors influencing successful colonoscopy outcomes.

Key Market Drivers

1. Rising Screening and Diagnosis Rates

A surge in colorectal cancer screening programs—especially in North America and Europe—propels demand for effective bowel prep solutions. Government initiatives, insurance coverage expansions, and heightened public awareness contribute to increased utilization of colonoscopy procedures [2].

2. Preference for Flavored, Palatable Solutions

Patient compliance hinges on taste and convenience. Traditional PEG solutions, often unflavored or unpleasant-tasting, face resistance. Flavor packs—like those accompanying Colyte—address this barrier, enhancing adherence and decreasing the likelihood of incomplete preparations.

3. Medical Advancements and Regulatory Approvals

Ongoing clinical trials and approvals reinforce safety and efficacy profiles. The FDA’s approval of various formulations, including flavored variants, bolsters market confidence. Moreover, ongoing pipeline developments aim to introduce low-volume or improved-bioavailability options that supplement Colyte's market positioning.

4. Competitive Dynamics

Major players, including Hospira (a Pfizer subsidiary), Braintree Laboratories, and Ferring Pharmaceuticals, compete in this space. FDI (Foreign Direct Investment) in emerging markets expands reach, especially in Asia-Pacific, where colorectal screening initiatives are gaining momentum [3].

Market Challenges

1. Price Sensitivity and Reimbursement Policies

Cost remains a barrier, particularly in markets with stringent reimbursement schemes or limited insurance coverage. Flavored formulations often command premium pricing, which may impact accessibility for lower-income segments.

2. Alternative Modalities

Emerging non-PEG-based agents, such as sodium sulfate-based solutions or oral preps with lower volume requirements, threaten market share. Additionally, advancements in non-invasive screening methods could diminish colonoscopy demand.

3. Side Effect Profiles and Compliance

While flavor packs improve taste, concerns regarding electrolyte imbalance, dehydration, or gastrointestinal discomfort persist, necessitating continuous safety evaluations and patient education.

Financial Trajectory Analysis

Revenue Streams and Growth Potential

Initial revenue for Colyte with Flavor Packs capitalized on its enhanced palatability. In 2022, Braintree Laboratories reported global sales of their bowel prep products, with flavored variants contributing approximately 65% of this segment, illustrating robust demand [4].

Forecasts suggest a CAGR of 4.8% for flavored bowel preps over the next five years, driven by increasing adoption in developed countries. The Asia-Pacific market, though currently smaller, is expected to grow at a CAGR exceeding 6%, fueled by rising awareness and healthcare infrastructure investment.

Market Penetration Strategies

Companies focus on physician education emphasizing patient compliance improvements. Clinical studies demonstrate higher completion rates when palatable formulations are used, which serve as a selling point for expanding market share.

Pricing Trends

Premium pricing persists due to added flavoring and convenience. However, price elasticity varies; in healthcare systems emphasizing cost-effectiveness, manufacturers may face pressure to reduce prices or introduce generic versions, impacting margins.

Profitability Outlook

Given high R&D costs absorbed during formulation refinement, profit margins are sensitive to scale and market penetration efficiency. Premium formulations like Colyte with Flavor Packs, with an established brand presence, tend to enjoy higher margins compared to unflavored counterparts.

Strategic Implications

Innovation and Diversification

Ongoing product innovation including low-volume formulations, improved electrolyte balance, and varied flavor options can sustain growth trajectories. Strategic collaborations and licensing agreements also facilitate faster entry into emerging markets.

Regulatory and Reimbursement Navigation

Proactively aligning with regulatory standards ensures uninterrupted market access. Collaborating with payers to demonstrate improved adherence and clinical outcomes can enhance reimbursement prospects.

Global Expansion

Targeted expansion into Asia-Pacific, Latin America, and the Middle East offers high-growth opportunities. Customizing flavor profiles to regional preferences and partnering with local healthcare providers are essential.

Conclusion

Colyte with Flavor Packs is positioned at the intersection of patient-centric innovation and expanding colorectal screening initiatives. Its market trajectory hinges upon overcoming cost barriers, competing with novel formulations, and adapting to evolving regulatory landscapes. As global demand for effective, palatable bowel prep solutions continues, brands that invest in innovation, market expansion, and strategic partnerships will likely enhance their financial performance in this segment.


Key Takeaways

  • The increasing demand for colonoscopy procedures, coupled with a shift toward patient-friendly preparations, underpins the growth of flavored bowel preps like Colyte with Flavor Packs.
  • Flavor enhancement significantly improves patient compliance, vital for effective colorectal screening programs.
  • Competitive dynamics, pricing strategies, and regulatory environments are critical determinants of the product’s financial success.
  • Emerging markets present substantial growth opportunities, especially through localization and strategic alliances.
  • Innovation in formulation and targeted marketing will be essential for sustaining revenue growth amid evolving technological and clinical landscapes.

FAQs

Q1: How does Colyte with Flavor Packs compare pharmacologically to unflavored PEG solutions?
A: Pharmacologically, Colyte with Flavor Packs contains the same active ingredients— PEG 3350—providing equivalent efficacy in bowel cleansing. Flavoring and taste masking improve patient compliance without altering the active drug's safety or effectiveness profile.

Q2: What are the primary barriers to market expansion for flavored bowel preps?
A: Key barriers include high formulation costs, reimbursement limitations, regional taste preferences, and competition from alternative preparations like low-volume or sodium-based solutions.

Q3: How significant is the role of regulatory approvals in Colyte’s market trajectory?
A: Regulatory approvals are crucial, providing legal clearance and clinical validation, which bolster physician confidence and facilitate market entry. Ongoing approvals also enable product line extensions and formulations.

Q4: What demographic trends are influencing demand for Colyte with Flavor Packs?
A: An aging population, higher screening rates among middle-aged adults, and increasing awareness are driving demand. Additionally, the preference for less discomfort and improved taste appeal enhances utilisation among younger and elderly patients.

Q5: What strategic actions should manufacturers pursue to maximize profitability for flavored bowel preps?
A: Companies should focus on innovation, expanding geographic presence, establishing payer partnerships to improve reimbursement, and investing in patient education campaigns to emphasize benefits and compliance.


Sources

[1] MarketsandMarkets, "Colonoscopy & Bowel Preparation Market," 2022.
[2] WHO, "Global Cancer Statistics," 2020.
[3] Allied Market Research, "Asia-Pacific Bowel Prep Market," 2021.
[4] Braintree Laboratories Annual Report, 2022.

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