Last Updated: May 10, 2026

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. Eight 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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Questions you can ask:
  • What is the 5 year forecast for COLYTE WITH FLAVOR PACKS?
  • What are the global sales for COLYTE WITH FLAVOR PACKS?
  • What is Average Wholesale Price for COLYTE WITH FLAVOR PACKS?
Summary for COLYTE WITH FLAVOR PACKS
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 6
DailyMed Link:COLYTE WITH FLAVOR PACKS at DailyMed
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: March 23, 2026

How does the market for bowel prep drugs like Colyte with flavor packs evolve?

The market for bowel preparation solutions, including Colyte with flavor packs, is driven by the rising prevalence of colorectal diseases, regulatory approvals, and patient preferences.

Market Size and Growth

  • The global bowel prep market was valued at approximately $720 million in 2021.
  • Compound annual growth rate (CAGR): Between 7% and 10% through 2026.
  • Key growth factors include increased colorectal cancer screening rates and innovation in patient-friendly formulations.

Market Segments

  • By formulation: Powder, liquid, and tablets.
  • By application: Colonoscopy, colorectal disease diagnosis, and treatment.
  • Regional distribution: North America (largest), Europe, Asia-Pacific.

Drivers

  • Increasing screening programs, especially in developed countries.
  • Patient demand for palatable, convenience-driven products.
  • Patent expirations and biosimilar competition influencing pricing and innovation.

How does Colyte with flavor packs fit into this market?

Colyte, a polyethylene glycol (PEG)-based solution, competes primarily in the colonoscopy prep segment. Flavored packs improve palatability, impacting patient compliance and repeat utilization.

Market Position

  • Market leader in PEG-based bowel prep solutions.
  • Launched with flavor packs to enhance taste and compliance rates.
  • Estimated to hold around 30%-35% of the PEG bowel prep market in the U.S.

Revenue Trajectory

  • In 2022, estimated U.S. sales: $350 million.
  • Expected CAGR: 8%-10% from 2023 to 2027.
  • Growth driven by increased colonoscopy procedures and adjustments in sales strategies to promote flavored variants.

Competitive Landscape

  • Competitors: MiraLAX (off-label for bowel prep), Fleet Phospho-soda, and newer low-volume preps.
  • Innovation focus: Novel flavor profiles, reduced volume, and alternative osmotic agents.
  • Insurance reimbursement policies favor established brands like Colyte due to proven efficacy.

How do regulatory policies influence sales?

Regulatory approvals and guidelines shape market access:

  • The U.S. Food and Drug Administration (FDA) approved Colyte for bowel prep in 2004.
  • Updated labeling emphasizes flavor options to boost compliance.
  • European Medicines Agency (EMA) approval in 2005 and regional variations impact distribution.

Financial outlook and key considerations

Revenue Breakdown

Year Estimated Revenue Growth Rate Key Drivers
2022 $350 million Stability in prescriptions, flavor packs adoption
2023 $380 million 8-10% Increased screening, awareness campaigns
2024-2026 Steady growth 8-10% annually Expanded regional reach, innovation in flavor profiles

Cost Factors

  • Manufacturing costs: Moderate, with favorable margins for established brands.
  • R&D expenditure: Focuses on flavor innovation and low-volume formulations.
  • Marketing: Significant investment in physician and patient education.

Pricing Strategy

  • Premium pricing in the flavored variant segment due to taste enhancements.
  • Reimbursement policies tend to favor FDA-approved, well-established products.

Future trends impacting revenue streams

  • Development of low-volume, quicker-acting preps with flavor options.
  • Increasing adoption of digital health tools to support patient compliance.
  • Potential biosimilar competition in the bowel prep segment after patent expirations.

Risks and challenges

  • Negative patient experiences, despite flavor improvements, may limit repeat use.
  • Regulatory changes could restrict marketing or labeling modifications.
  • Competitive pressures from generics and alternative prep drugs may pressure prices.

Summary of Key Financial Indicators

  • Market size: $720 million (2021).
  • Colyte with flavor packs: 30%-35% market share.
  • Revenue forecast (2023-2027): $380 million to $500 million.
  • CAGR expectation: 8%-10%.

Key Takeaways

  • The bowel prep market is expanding driven by increased screening and innovations.
  • Colyte with flavor packs remains a leading product, with a steady revenue trajectory.
  • Growth depends on regional adoption, patient preferences, and competitive innovations.
  • Regulatory policies and reimbursement practices significantly impact sales.
  • Future growth includes low-volume formulations and enhanced flavor innovations.

5 FAQs

1. What factors most influence Colyte’s market share?
Patient compliance, flavor options, physician recommendations, and reimbursement policies.

2. How are regulatory changes impacting Colyte’s sales?
FDA approvals and labeling updates that promote flavor options support sales; restrictive regulations could hinder marketing.

3. What competitive threats exist for Colyte?
Generic PEG solutions, new low-volume preps, and alternative purification agents.

4. How does flavor pack innovation affect revenue?
Enhanced flavor profiles improve patient adherence, leading to increased repeat prescriptions and higher market penetration.

5. What is the projected growth rate for Colyte with flavor packs?
Between 8% and 10% annually through 2027, driven by expansion in screening programs and product innovation.


References

[1] MarketWatch. (2022). Global bowel prep market size and forecasts.
[2] U.S. Food and Drug Administration. (2004). FDA approval for Colyte.
[3] Grand View Research. (2022). Prebiotics and bowel prep market analysis.

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