POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - Generic Drug Details

What are the generic sources for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride and what is the scope of patent protection?

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride is the generic ingredient in nineteen branded drugs marketed by L Perrigo Co, Braintree, Extrovis, Novel Labs Inc, Solis Pharms, Strides Pharma, Aurobindo Pharma Usa, Paddock Llc, Hospira, Quagen, Vintage Pharms, Dynapharm, E Z Em, Goldline, and Sandoz, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

US Patents:	0
Tradenames:	19
Applicants:	15
NDAs:	22
Finished Product Suppliers / Packagers:	3
Clinical Trials:	1
DailyMed Link:	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

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

Sponsor	Phase
Temple University	Phase 4

See all POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE clinical trials

Pharmacology for POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Drug Class	Osmotic Laxative Potassium Salt
Mechanism of Action	Osmotic Activity Alkalinizing Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Anatomical Therapeutic Chemical (ATC) Classes for POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

A12BA	Potassium
A12B	POTASSIUM
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

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	018983-010	Jan 31, 1989		DISCN	No	No
Quagen	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-006	Oct 26, 1984		DISCN	No	No
Paddock Llc	POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	090712-001	Feb 25, 2010		DISCN	No	No
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
Vintage Pharms	CO-LAV	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SUSPENSION;ORAL	073428-001	Jan 28, 1992		DISCN	No	No

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Polyethylene Glycol 3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Last updated: July 29, 2025

Introduction

The pharmaceutical market for combination products comprising polyethylene glycol 3350 (PEG 3350), potassium chloride (KCl), sodium bicarbonate, and sodium chloride remains shaped by evolving clinical needs, regulatory landscapes, and manufacturing innovations. These components feature prominently in osmotic laxatives, electrolyte replenishment therapies, and acid-base regulation, positioning them as essential commodities within gastrointestinal and electrolyte management domains.

This analysis delineates current market dynamics and forecasts financial trajectories, emphasizing key drivers, challenges, and strategic opportunities influencing growth prospects for this therapeutic combination.

Market Landscape Overview

The formulary composition involving PEG 3350, KCl, sodium bicarbonate, and sodium chloride addresses broad clinical applications, ranging from constipation relief to correction of electrolyte imbalances. The global demand is driven by increasing prevalence of gastrointestinal disorders and electrolyte disturbances linked to aging populations, chronic diseases, and hospitalizations, especially amid the COVID-19 pandemic’s impact on healthcare workflows.

Market Segmentation and Key Applications

• Osmotic Laxatives: Polyethylene glycol 3350 predominantly treats chronic constipation and bowel preparation. The segment sustains robust growth due to aging demographics and a shift toward minimally invasive bowel cleansing procedures.
• Electrolyte Replenishment: Potassium chloride, sodium bicarbonate, and sodium chloride form core ingredients in formulations for saline infusions, rehydration solutions, and treatments for electrolyte depletion, especially in patients with dehydration from diarrhea or vomiting.
• Multi-Component Formulations: Combination drugs incorporating these ingredients are formulated for ease of administration, enhancing compliance and clinical efficacy.

Market Drivers

Increasing Prevalence of Gastrointestinal and Electrolyte Disorders

Globally rising cases of constipation, dehydration, and electrolyte imbalance propel demand. WHO estimates over 2.5 billion individuals suffer from chronic constipation, expanding the market for PEG-based products [1].

Aging Population and Chronic Disease Burden

Demographic shifts underscore an expanding elderly population with heightened susceptibility to gastrointestinal and electrolyte issues, which in turn boosts the market for these medications.

Healthcare System Expansion and Investment

Emerging markets, notably in Asia-Pacific, exhibit intense investment in healthcare infrastructure, catalyzing procurement and distribution of these drugs. Additionally, increased hospitalizations due to infectious diseases and chronic conditions amplify usage.

Regulatory Support and Patent Expirations

Regulatory approvals for novel formulations, combined with the patent expiration of some branded products, create opportunities for generic manufacturers, broadening access and driving price competition.

Technological and Manufacturing Innovations

Advancements in formulation technology enhance bioavailability, stability, and patient compliance, further stimulating market growth.

Market Challenges

Stringent Regulatory Frameworks

Regulatory agencies like the FDA and EMA enforce rigorous standards for safety and efficacy, potentially prolonging drug approval processes and increasing compliance costs.

Pricing Pressures and Reimbursement Policies

Healthcare payers worldwide seek cost-effective therapies, exerting downward pressure on drug prices and affecting profit margins, particularly for generic manufacturers.

Competition from Alternative Treatments

Emerging therapies and natural remedies, along with non-pharmacological interventions, pose substitution threats in certain applications.

Supply Chain and Raw Material Constraints

Volatility in raw material costs and disruptions—exacerbated by geopolitical tensions and pandemic-related logistics issues—can influence manufacturing costs and market availability.

Financial Trajectory and Forecasts

Historical Financial Performance

The global market for osmotic laxatives and electrolyte therapies, dominated by PEG 3350 and electrolytes, was valued at approximately USD 2.9 billion in 2021, with a CAGR of around 4.8% projected through 2030 [2]. The dominance of generic products, especially in mature markets, has constrained margins but facilitated widespread access.

Projected Growth and Revenue Drivers

Northern Hemisphere markets, particularly North America and Europe, will continue to lead, driven by high adoption rates and robust healthcare infrastructure. The Asia-Pacific region is forecasted for the most rapid growth, with an expected CAGR of over 6% through 2030, fueled by healthcare expansion and the growing burden of gastrointestinal and electrolyte disorders.

Innovative Formulations and Market Entry

Emergence of novel drug delivery systems—such as sustained-release formulations and combination therapy tablets—are anticipated to enhance market share and generate incremental revenue streams.

Impact of COVID-19

The pandemic temporarily disrupted supply chains and deferred elective procedures, but it also heightened awareness around hydration and electrolyte balance, intensifying demand in acute care settings. Post-pandemic recovery continues to support both volume and value growth.

Competitive Landscape

Large pharmaceutical companies like GlaxoSmithKline, Sanofi, and generic manufacturers such as Teva and Pfizer dominate the market, with public and private sector investments in biosimilar and generic drugs aligning with lower-cost provider strategies.

Future Outlook

By 2030, the market's valuation is projected to reach USD 4.5–5 billion, reflecting sustained demand, innovation, and geographical expansion. The growth trajectory depends significantly on regulatory policies, patent landscape shifts, and the pace of technological adaptation.

Regulatory and Market Access Considerations

Regulatory bodies are increasingly emphasizing safety profiles, pharmacovigilance, and manufacturing standards, especially in emerging markets. Companies that effectively navigate these frameworks and secure approvals for novel formulations or combinations can capitalize on unmet needs and accelerate revenue growth.

Market access strategies, including establishing collaborations with healthcare providers and payers, are vital. The integration of real-world evidence to support clinical efficacy and cost-savings offers competitive advantages.

Conclusion

The pharmaceutical landscape for PEG 3350, potassium chloride, sodium bicarbonate, and sodium chloride integrations presents lucrative opportunities, driven by demographic trends, rising disease prevalence, and technological advances. While challenges such as regulatory hurdles and pricing pressures persist, strategic innovation and market expansion, particularly into emerging economies, are poised to shape robust financial trajectories for industry players.

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Key Takeaways

• The global market for combination therapies involving PEG 3350 and electrolytes is projected to grow at a CAGR of approximately 5-6% until 2030.
• Increasing prevalence of GI and electrolyte disorders, coupled with demographic shifts, constitute primary growth drivers.
• Innovation in drug formulations, along with expanding healthcare infrastructure in developing regions, will sustain revenue growth.
• Competition from generics and regulatory challenges necessitate strategic positioning, including value demonstration and supply chain resilience.
• Companies should focus on regulatory compliance, geographical expansion, and innovative delivery systems to maximize market share and profitability.

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FAQs

1. What factors are driving the demand for PEG 3350 and electrolyte-based combination drugs?
Rising cases of constipation, dehydration, and electrolyte imbalances, especially among aging populations and hospitalized patients, are primary drivers. Technological advancements and increasing healthcare investments also contribute.

2. How does regulatory approval impact the financial prospects of these drugs?
Stringent safety and efficacy standards can delay market entry and increase costs, but successful approvals and subsequent patent protections can lead to high-margin products and market dominance.

3. What are the main challenges facing manufacturers in this market?
Limited pricing flexibility, raw material cost volatility, regulatory compliance demands, and competition from generics pose ongoing challenges.

4. Which emerging markets offer the greatest growth potential?
Asia-Pacific countries like China and India exhibit significant expansion potential due to rising healthcare spending, increasing disease burden, and supportive regulatory reforms.

5. How might technological innovation influence future market dynamics?
Advances in drug delivery mechanisms, combination formulations, and personalized medicine will enhance efficacy, compliance, and market penetration, shaping future growth trends.

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Sources
[1] World Health Organization. (2020). Gastrointestinal Disorders Report.
[2] Market Research Future. (2022). Global Laxatives and Electrolytes Market Analysis.