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Last Updated: February 2, 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. 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-FLAVORED
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 6
DailyMed Link:COLYTE-FLAVORED at DailyMed
Drug patent expirations by year for COLYTE-FLAVORED
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 ⤷  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
>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-FLAVORED

Last updated: July 28, 2025

Introduction

COLYTE-FLAVORED, a flavored variant of the established oral rehydration solution (ORS) product, targets dehydration caused by diarrhea and other fluid loss conditions. The burgeoning demand for electrolyte-based hydration therapies, driven by growing incidences of gastrointestinal diseases and the rising focus on infant and pediatric health, underscores its market significance. This report analyzes the market dynamics shaping COLYTE-FLAVORED’s trajectory and projects its financial outlook, considering industry trends, competitive landscape, regulatory factors, and consumer preferences.

Market Overview

The Global Oral Rehydration Therapy Market

The global oral rehydration therapy (ORT) market has demonstrated consistent growth over the past decade, buoyed by increased awareness of dehydration risks in vulnerable populations, advancements in formulation technology, and expanded distribution channels. According to MarketsandMarkets, the ORT market was valued at approximately USD 1.2 billion in 2021 and is projected to reach USD 2.0 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of about 8% [1].

Segment Focus: Flavored ORS Variants

Flavored ORS solutions, including COLYTE-FLAVORED, constitute a niche yet rapidly expanding segment within the broader ORT market. Consumer preferences favor palatable formulations, especially among children and in regions where taste influences compliance. The flavoring agents improve overall acceptability, thus reducing the resistance to administration, especially in pediatric care.

Target Markets

Key markets include South Asia (India, Bangladesh, Pakistan), Africa, Southeast Asia, and parts of Latin America, where diarrhea remains a leading cause of mortality among children under five. The World Health Organization (WHO) estimates that ORS has saved over 50 million lives since its inception in the 1970s [2]. Emerging markets are particularly receptive due to increasing healthcare infrastructure and awareness campaigns.

Market Dynamics Influencing COLYTE-FLAVORED

Drivers

1. Rising Disease Burden and Healthcare Awareness

The prevalence of diarrhea and other dehydration-causing illnesses continues to drive demand for effective rehydration solutions. The World Gastroenterology Organisation notes a persistent global burden, with economic and social implications fueling investments in improved ORT formulations [3].

2. Consumer Preferences for Palatable Formulations

Taste remains a key factor influencing compliance, particularly in pediatric care. Flavored ORS formulations like COLYTE-FLAVORED enhance adherence, thereby expanding market adoption.

3. Innovations in Formulation Technology

Advances in flavoring agents and stabilizers have enhanced product acceptability without compromising efficacy. Increased R&D investments focus on taste-masking, shelf stability, and ease of use.

4. Growing Focus on Pediatric and Infant Health

Regulatory agencies and healthcare providers emphasize tailored solutions. Pediatric-friendly, flavored ORS options differ from traditional unflavored solutions, expanding market segments.

5. Distribution Expansion and Public-Private Partnerships

Partnerships with governments, NGOs, and global health agencies facilitate widespread deployment, especially in low-income regions.

Restraints

1. Price Sensitivity and Affordability

Low-income markets prioritize cost-effective solutions. Premium flavored variants may face resistance if priced higher than traditional solutions.

2. Regulatory Challenges

Stringent approval processes and quality standards across diverse jurisdictions potentially delay market entry and increase costs.

3. Competition from Alternative Therapies

Emergence of novel dehydration management solutions, including IV therapy and probiotic-based treatments, challenge traditional ORS segments.

4. Limited Awareness and Cultural Barriers

In some regions, traditional remedies and lack of awareness hamper adoption rates of ORS solutions, including flavored variants.

Opportunities

1. Expansion into Emerging Markets

Growing healthcare infrastructure combined with government initiatives aimed at reducing childhood mortality present significant opportunities.

2. Product Diversification

Introduction of multi-flavor options, sugar-free variants, and formulations with added micronutrients could further expand market share.

3. Strategic Collaborations

Partnerships with local distributors, health agencies, and aid organizations can enhance reach and acceptance.

4. Digital and Educational Campaigns

Leveraging digital marketing to increase awareness about the benefits of flavored ORS solutions supports market penetration.

Competitive Landscape

Major players in the ORT market include Pfizer, GastroEnterology, Inc., and SmithKline Beecham (now part of GlaxoSmithKline), among others focusing on pediatric and adult formulations. COLYTE-FLAVORED’s differentiation arises from its flavor profile, convenience, and targeted marketing campaigns.

Emerging regional brands also offer flavored solutions, often at lower price points, intensifying competition. Patent protections, proprietary flavoring technologies, and distribution networks are critical factors influencing market positioning.

Financial Trajectory and Forecast

Revenue Projections

Based on industry growth rates, population demographics, and product acceptance, the revenue potential for COLYTE-FLAVORED can be estimated. Assuming its capture of 3-5% of the global ORT market within five years, revenues could range between USD 60-100 million globally.

Pricing Strategy and Margins

Premium pricing, justified by flavor enhancement and marketing efforts, could help sustain gross margins of approximately 45-55%. Cost reduction via economies of scale in manufacturing and strategic sourcing could further improve profitability.

Investment and R&D Outlook

Investment in flavor technology, packaging, and distribution is essential. R&D budgets comprising 10-15% of sales foster innovation and compliance, ensuring market competitiveness.

Regional Dynamics and Revenue Distribution

  • Asia-Pacific: Dominant with over 60% market share due to high disease burden and population size.
  • Africa: Rapidly growing segment driven by government initiatives, albeit limited by affordability constraints.
  • Latin America: Moderate growth, with increasing awareness campaigns.
  • Europe and North America: Niche markets focusing on travelers, specific pediatric formulations, or emergency use.

Risks and Contingencies

Market expansion relies heavily on regulatory compliance, cultural acceptance, and the ability to maintain competitive pricing. Disruptions in supply chain, raw material cost fluctuations, or regulatory delays pose financial risks.

Key Regulatory Considerations

Regulatory approvals from agencies such as the U.S. FDA, EMA, and WHO prequalifications influence market entry. Complying with standards pertaining to safety, efficacy, and manufacturing practices remains crucial. Fast-track approvals or emergency use authorizations can accelerate product availability in crisis contexts.

Conclusion

The market for flavored oral rehydration solutions, exemplified by COLYTE-FLAVORED, is poised for sustained growth, underpinned by global health trends favoring pediatric and hydration therapy solutions. Strategic focus on innovation, affordability, regulatory compliance, and distribution will dictate financial success. As awareness and healthcare infrastructure advance, the revenue trajectory for COLYTE-FLAVORED appears promising, with considerable opportunities in emerging markets.


Key Takeaways

  • The global ORT market is expanding at a CAGR of approximately 8%, with flavored variants like COLYTE-FLAVORED gaining prominence due to consumer preferences for taste.
  • Rising incidence of dehydration-related illnesses, especially in children, underpins sustained demand.
  • Market success hinges on balancing premium product features with affordability, particularly in low-income regions.
  • Strategic collaborations, innovation, and compliance with regulatory standards are critical to capturing market share.
  • Regional opportunities are significant in Asia-Pacific and Africa, with potential for product diversification to meet diverse consumer needs.

FAQs

1. What differentiates COLYTE-FLAVORED from traditional ORS solutions?
COLYTE-FLAVORED offers enhanced taste profiles through added flavors, improving palatability and compliance, especially in children. Its formulation maintains the efficacy of traditional ORS while increasing consumer acceptance.

2. How does flavoring impact the marketability of ORS solutions?
Flavoring significantly boosts adherence and preference, leading to higher usage rates, particularly among pediatric and sensitive populations. It creates a competitive edge in regions where taste resistance hampers traditional solutions.

3. What are the main challenges faced by flavored ORS products like COLYTE-FLAVORED?
Challenges include regulatory approval hurdles, higher production costs, price sensitivity among markets, and competition from generic or alternative therapies.

4. Which markets present the highest growth potential for COLYTE-FLAVORED?
Emerging markets in South Asia, Africa, and Southeast Asia offer the highest growth due to high disease burden, increasing healthcare access, and supportive government initiatives.

5. What strategies can companies adopt to maximize ROI for flavored ORS products?
Key strategies include tailored pricing, local partnerships, focused marketing campaigns emphasizing health benefits, expanding flavor portfolios, and investing in regulatory compliance and supply chain efficiency.


References

[1] MarketsandMarkets, “Oral Rehydration Therapy Market by Product (Packets, Solutions, Others), Application (Diarrheal Diseases, Dehydration, Other), Age Group, and Region — Global Forecast to 2027,” 2022.
[2] World Health Organization, “The Treatment of Diarrhoea: A Manual for Physicians and Other Senior Health Workers,” 2005.
[3] World Gastroenterology Organisation, “Global Burden of Gastrointestinal Diseases,” 2019.

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