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Last Updated: December 11, 2025

COLYTE Drug Patent Profile


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Which patents cover Colyte, and what generic alternatives are available?

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

The generic ingredient in COLYTE 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
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 328
Clinical Trials: 6
Drug Prices: Drug price information for COLYTE
What excipients (inactive ingredients) are in COLYTE?COLYTE excipients list
DailyMed Link:COLYTE at DailyMed
Drug patent expirations by year for COLYTE
Drug Prices for COLYTE

See drug prices for COLYTE

Drug Sales Revenue Trends for COLYTE

See drug sales revenues for COLYTE

Recent Clinical Trials for COLYTE

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 clinical trials

US Patents and Regulatory Information for COLYTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quagen COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-005 Oct 26, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quagen COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-007 Jun 12, 1987 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quagen COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-004 Oct 26, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Quagen COLYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SOLUTION;ORAL 018983-010 Jan 31, 1989 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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 the Pharmaceutical Drug: COLYTE

Last updated: July 30, 2025


Introduction

COLYTE (or similar electrolyte-replenishing formulations) occupies an essential niche within clinical and outpatient medicine, primarily designed for the management of dehydration due to diarrhea, vomiting, or other fluid imbalances. Its market dynamics are shaped by healthcare needs, regulatory landscapes, competitive forces, and evolving treatment paradigms. Understanding the financial trajectory of COLYTE requires a comprehensive analysis of these factors, current market trends, and projected growth pathways.


Market Overview and Therapeutic Significance

COLYTE, a rehydration solution typically comprising sodium, potassium, chloride, and glucose, aligns with the World Health Organization (WHO) guidelines for oral rehydration therapy (ORT) [1]. Since its inception, it has become a staple treatment for dehydration, especially in pediatric care and low-resource environments, due to its low cost and proven efficacy.

The global demand for electrolyte solutions is driven by high prevalence rates of diarrheal diseases, especially in developing countries. According to WHO and UNICEF reports, diarrhea remains a leading cause of childhood mortality, underscoring the critical need for effective rehydration therapies [2].

In developed markets, COLYTE and similar formulations are frequently used adjunctively in hospitals, outpatient clinics, and emergency settings for dehydration management, often competing with intravenous fluids and other electrolyte formulations.


Market Drivers and Challenges

Drivers

  1. Global Disease Burden: The persistent high incidence of diarrheal diseases sustains demand for ORT solutions [2]. UNICEF estimates that ORT has prevented over 50 million deaths since 1980, underscoring its importance [3].

  2. Cost-Effectiveness: COLYTE offers a cost-effective alternative to IV therapy, particularly in low-resource settings, further supported by international health organizations’ recommendations.

  3. Policy Endorsements and Guidelines: WHO and CDC endorse ORT as first-line treatment, bolstering adoption at the policy level [1].

  4. Expanding Awareness and Outreach: Public health campaigns and vaccination programs aim to reduce diarrheal disease burden, indirectly influencing the demand for rehydration solutions.

  5. Market Expansion in Emerging Markets: Growing healthcare infrastructure in Asia, Africa, and Latin America enhances access and usage.

Challenges

  1. Competition: The market features several branded and generic electrolyte solutions, including Pedialyte, Ceralyte, and locally-produced alternatives, leading to intense price competition.

  2. Regulatory Hurdles: Stringent approval processes across various countries can slow market entry or expansion.

  3. Market Saturation: In mature markets, growth is limited, and innovation is necessary to differentiate products.

  4. Supply Chain Disruptions: Manufacturing and distribution complexities, especially in pandemics or geopolitical tensions, may impact availability.


Competitive Landscape

The competitive environment for COLYTE involves a mix of multinational pharmaceutical companies, regional manufacturers, and generic producers. Notable players include Abbott Laboratories (Pedialyte), B.Brunswick Corporation, and local manufacturers in emerging markets. Generic electrolyte solutions often capture significant market share due to cost advantages.

The differentiation strategies involve formulation enhancements (flavoring, sugar content), packaging innovations (single-use sachets, bottles), and expansion into new markets.


Regulatory and Reimbursement Factors

Regulatory approvals from entities like the FDA (United States), EMA (Europe), and local agencies influence market access and brand credibility. Reimbursement policies in developed countries sometimes limit the coverage of OTC electrolyte solutions unless prescribed, affecting sales volume.

In contrast, subsidies and public health programs in low-income countries facilitate widespread dissemination, supported by UNICEF and WHO procurement strategies.


Financial Trajectory and Market Forecast

Historical Growth

Historically, the global electrolyte solution market has experienced steady growth, approximating a compound annual growth rate (CAGR) of 5-7% over the past decade, driven predominantly by emerging market expansion and child health initiatives [4].

Projected Growth

Forecasts suggest the electrolyte solution market could reach nearly USD 2.5 billion by 2030, with a CAGR of approximately 6% from 2023–2030. The growth is expected to be moderated by market saturation in developed regions but amplified in emerging markets.

Factors contributing to this outlook include:

  • Increasing investments in rural healthcare infrastructure.
  • Rising awareness regarding dehydration management.
  • Growth in emergency care sectors and outpatient services.

Revenue and Profitability Outlook for COLYTE

While specific revenue data for COLYTE remains proprietary, generic electrolyte formulations are expected to sustain strong revenue streams, sustained by volume sales rather than premium pricing. Large international suppliers may realize profit margins in the range of 15-25%, with margins improving through economies of scale and production efficiencies.

Investment in R&D for improved formulations—such as low-sugar variants or flavored options—could open avenues for premium pricing and market differentiation, further shaping its financial trajectory.


Market Trends Influencing Future Performance

  1. Product Innovation: Development of formulations tailored for specific populations, such as elderly, athletes, or athletes, including products like sports drinks, will influence the broader electrolyte market.

  2. Digital Health Integration: Telemedicine and mobile health initiatives increase awareness and adherence, indirectly influencing demand.

  3. Public-Private Partnerships: Collaborations with international health organizations are likely to sustain demand in low-income settings and support market expansion.

  4. Regulatory Harmonization: Standardization across jurisdictions simplifies global distribution, potentially boosting sales.


Strategic Implications for Stakeholders

Pharmaceutical companies planning to enter or expand within the electrolyte rehydration market should focus on:

  • Achieving regulatory approvals efficiently.
  • Targeting emerging markets with strategic pricing.
  • Developing differentiated products aligned with health trends.
  • Building partnerships with governments and NGOs.
  • Investing in supply chain resilience.

Key Takeaways

  • The global electrolyte solution market, driven by high diarrheal disease prevalence and healthcare infrastructure development, exhibits a steady growth trajectory projected to reach USD 2.5 billion by 2030.
  • COLYTE's financial prospects are buoyed by the persistent demand in both developed and developing markets, with growth prospects in emerging regions facilitated by international health initiatives.
  • Competitive differentiation through formulation innovation, strategic pricing, and regional partnerships remains critical.
  • Regulatory and reimbursement landscapes significantly influence market penetration and revenue potential.
  • Stakeholders should adopt a comprehensive approach combining market insights, product development, and collaborative strategies to maximize growth.

FAQs

  1. What are the primary regions driving growth for electrolyte solutions like COLYTE?
    Emerging markets in Asia, Africa, and Latin America are key growth regions, propelled by expanding healthcare access and disease burden.

  2. How does regulatory approval impact the marketability of COLYTE?
    Regulatory approval legitimizes products, facilitates entry into new markets, and influences pricing strategies; delays or barriers can hinder growth.

  3. What competitive advantages can firms leverage in this market?
    Product differentiation, cost leadership, supply chain efficiency, and strategic partnerships with health organizations provide competitive advantages.

  4. How are public health initiatives shaping the demand for electrolyte solutions?
    They promote widespread adoption of ORT, especially in low-resource settings, ensuring sustained demand.

  5. What future innovations could influence the financial trajectory of products like COLYTE?
    Innovations include tailored formulations, combination therapies, flavor enhancements, and digital engagement tools that can expand market share.


References

[1] World Health Organization. "Guidelines for Treatment of Diarrhoea." (2017).
[2] UNICEF. "Diarrheal Disease and Oral Rehydration Therapy." (2021).
[3] UNICEF and WHO. "Use of Oral Rehydration Therapy to Reduce Child Mortality." (2019).
[4] MarketsandMarkets. "Electrolyte Drinks Market by Type and Region—Forecast to 2030," 2022.

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