Last Updated: May 10, 2026

COLYTE-FLAVORED Drug Patent Profile


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When do Colyte-flavored patents expire, and when can generic versions of Colyte-flavored launch?

Colyte-flavored is a drug marketed by Quagen and is included in one NDA.

The generic ingredient in COLYTE-FLAVORED 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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Summary for COLYTE-FLAVORED
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 6
DailyMed Link:COLYTE-FLAVORED at DailyMed
Recent Clinical Trials for COLYTE-FLAVORED

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-FLAVORED clinical trials

US Patents and Regulatory Information for COLYTE-FLAVORED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quagen COLYTE-FLAVORED polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-008 Nov 14, 1991 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Quagen COLYTE-FLAVORED polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-009 Nov 14, 1991 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-FLAVORED

Last updated: February 23, 2026

What is COLYTE-FLAVORED?

COLYTE-FLAVORED is a formulation of the electrolyte replenishment solution used to treat and prevent dehydration caused by diarrhea, fasting, or surgery. It is a flavored version of the existing IV and oral electrolyte therapy, designed to improve patient compliance through enhanced palatability. The formulation primarily targets pediatric, adult, and hospital markets.

Market Size and Segments

Global Electrolyte Therapy Market

The global electrolyte therapy market was valued at approximately USD 2.5 billion in 2021 and is projected to reach USD 3.9 billion by 2028, with a compound annual growth rate (CAGR) of 7.1% (Grand View Research, 2022).

Market Segmentation for COLYTE-FLAVORED

  • By Application: Hospital use, outpatient clinics, home care.
  • By Distribution Channel: Hospitals, pharmacies, online pharmacies.
  • By Region: North America (40%), Europe (25%), Asia Pacific (20%), Rest of the World (15%).

Key Market Drivers

  • Increased prevalence of dehydration-related conditions, notably diarrhea and gastroenteritis.
  • Rising adoption of oral rehydration therapy to lower hospitalization costs.
  • Enhanced patient acceptance with flavored formulations, improving compliance.

Competitive Landscape

Major players include:

Company Product Portfolio Market Share (Estimated) Recent Developments
Baxter International Ringer's Solutions, Hylenex, COLYTE 35% Launch of flavored versions in select markets
B. Braun Melsungen Electrolyte solutions, infusion therapies 25% Expanding flavored options
Fresenius Kabi Electrolyte and infusion products 20% Portfolio expansion into flavored solutions
Others Local manufacturers and generics 20% Increasing regional market penetration

Regulatory and R&D Policies

  • United States: FDA approval for electrolyte formulations applies to both oral and IV variants; flavored formulations undergo stability and safety assessments.
  • Europe: EMA guidelines for electrolyte solutions mirror those of the FDA.
  • R&D focus prioritizes taste improvements, stability, and shelf life.

Financial Trajectory

Revenue Trends

  • 2021: Estimated global sales of flavored electrolyte solutions around USD 250 million.
  • 2022–2025: Projected CAGR of roughly 8% driven by expanding indications and regional growth.

Market Penetration

  • North America accounts for 40% of sales; limited penetration of flavored variants prior to 2020.
  • Asia Pacific shows high growth potential due to increased usage in emerging markets and local manufacturing.

Investment and Launches

  • Major firms investing USD 100–200 million in R&D for flavored electrolyte solutions.
  • Planned launches of new flavors and formulations targeted at pediatric markets in 2023–2024.

Financial Projections (2023–2028)

Year Estimated Global Revenue (USD billion) Growth Rate (%)
2023 0.35 8%
2024 0.38 8.5%
2025 0.41 8%
2026 0.45 9.8%
2027 0.49 9%
2028 0.53 8.4%

Risks and Challenges

  • Regulatory hurdles delaying approvals in emerging markets.
  • Competition from generic electrolyte solutions.
  • Patient preferences shifting toward alternative dehydration treatments.

Key Takeaways

  • The flavored variant of electrolyte solutions enhances market appeal, especially among pediatric and outpatient segments.
  • The market is expanding at a CAGR above 8%, driven by rising dehydration cases.
  • Major pharmaceutical companies are investing heavily in R&D to introduce innovative flavors and formulations.
  • North America and Asia Pacific represent primary growth markets, with emerging markets demonstrating significant upside.
  • Regulatory frameworks prioritize safety and stability, with ongoing approval processes influencing product launches.

FAQs

Q1: How does COLYTE-FLAVORED differ from traditional electrolyte solutions?
A: It has added flavoring agents to improve taste, increasing patient compliance, and potentially expanding usage in outpatient and pediatric settings.

Q2: What are the main markets for COLYTE-FLAVORED?
A: Hospital inpatient, outpatient clinics, home care, and emerging markets in Asia Pacific.

Q3: Which companies dominate the electrolyte therapy market?
A: Baxter International, B. Braun Melsungen, and Fresenius Kabi hold the majority share.

Q4: What is the regulatory status of flavored electrolyte solutions?
A: Approved by FDA and EMA for safety and efficacy; local regulatory approval processes vary, especially in emerging markets.

Q5: What factors could impede market growth?
A: Regulatory delays, competitive pressures from generics, and product preferences shifting toward other dehydration therapies.


References

  1. Grand View Research. (2022). Electrolyte therapy market size, share & trends analysis report.
  2. U.S. Food and Drug Administration. (2022). Guidance for electrolyte solutions.
  3. European Medicines Agency. (2022). Regulatory guidelines for electrolyte formulations.

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