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

What are the generic drug sources for polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous and what is the scope of freedom to operate?

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous is the generic ingredient in twelve branded drugs marketed by Quagen, Braintree, Extrovis, Novel Labs Inc, Paddock Llc, Strides Pharma, Vintage Pharms, Dynapharm, E Z Em, Goldline, and Sandoz, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

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

US Patents:	0
Tradenames:	12
Applicants:	11
NDAs:	13
Finished Product Suppliers / Packagers:	6
Clinical Trials:	1
DailyMed Link:	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS at DailyMed

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

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; SODIUM SULFATE ANHYDROUS clinical trials

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

Drug Class	Osmotic Laxative Potassium Salt
Mechanism of Action	Osmotic 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; SODIUM SULFATE ANHYDROUS

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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

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; SODIUM SULFATE ANHYDROUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vintage Pharms	GO-EVAC	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SUSPENSION;ORAL	073433-001	Apr 28, 1992		DISCN	No	No
Dynapharm	COLOVAGE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SUSPENSION;ORAL	071320-001	Apr 20, 1988		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
Braintree	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011-001	Jul 13, 1984	AA	RX	Yes	Yes

Market Dynamics and Financial Trajectory for Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous

Last updated: July 31, 2025

Introduction

The pharmaceuticals and over-the-counter (OTC) markets extensively utilize key active ingredients such as polyethylene glycol 3350 (PEG 3350), potassium chloride, sodium bicarbonate, sodium chloride, and sodium sulfate anhydrous. These compounds serve critical roles in laxatives, electrolyte replenishment, and alkalinity regulation, underpinning their longstanding commercial viability. Understanding the evolving market dynamics and financial trajectories surrounding these components is imperative for stakeholders aiming to capitalize on current opportunities and anticipate future trends.

Market Overview

Polyethylene Glycol 3350 (PEG 3350)

PEG 3350 is predominantly used as an osmotic laxative for treating occasional constipation and bowel cleansing procedures. The segment's growth is driven by aging populations, increasing prescription rates, and a burgeoning demand for OTC solutions. The global PEG market was valued at approximately USD 295 million in 2021 and is projected to grow at a CAGR of around 6% through 2028 (CAGR estimation based on industry reports).

Potassium Chloride

Used chiefly as an electrolyte replenisher and in cardiac treatment for potassium deficiency, potassium chloride's market is influenced by a combination of prescription and OTC sectors. The expanding prevalence of cardiovascular diseases and electrolyte imbalance conditions bolsters demand. The market was estimated at USD 2.1 billion in 2021, with a projected CAGR of 4-5% over the next five years.

Sodium Bicarbonate

Sodium bicarbonate, a versatile agent in gastric acidity management, acidosis correction, and as an emergency buffer, witnesses robust growth driven by hospital and OTC sectors. The global sodium bicarbonate market surpassed USD 450 million in 2021, with annual growth forecasts of approximately 4%.

Sodium Chloride

Utilized in rehydration, intravenous fluids, and as a compensatory electrolyte, sodium chloride's market remains stable but with steady growth prospects. The market's valued at over USD 1.8 billion, driven by medical, food, and industrial applications, expanding at a CAGR of around 3-4%.

Sodium Sulfate Anhydrous

Primarily employed in pharmaceutical industry as a laxative and in production processes, sodium sulfate anhydrous’s market is relatively niche but contains growth opportunities in generic laxatives and manufacturing sectors. Its estimated market value is smaller but growing at a CAGR of 4-6%.

Market Dynamics

Drivers

• Demographic Shifts: Aging populations globally increase prevalence of gastrointestinal and electrolyte imbalance conditions, elevating demand.
• Chronic Disease Prevalence: Rising cardiovascular and metabolic disorders directly influence the need for electrolyte solutions such as potassium chloride.
• Regulatory Approvals and OTC Accessibility: Increased regulatory approvals and OTC formulations bolster consumer access, expanding markets.
• Technological Advancements: Innovations in drug formulation enhance efficacy and safety, sparking growth across these compounds.
• Manufacturing Scalability: Cost-effective production, especially in emerging markets, contributes to competitive pricing and wider availability.

Constraints

• Stringent Regulation: Regulatory hurdles and safety concerns, especially regarding electrolyte imbalance risks, inhibit market expansion.
• Price Pressures: Intense competition and generic proliferation compress margins.
• Supply Chain Disruptions: Raw material shortages and logistical challenges, exacerbated by global crises (e.g., COVID-19), impact manufacturing sustainability.
• Environmental and Safety Regulations: Stricter waste and disposal regulations necessitate sustainable manufacturing practices, increasing operational costs.

Emerging Trends

• Biotechnological Innovations: Development of novel formulations and delivery systems is improving patient compliance.
• Market Expansion in Emerging Economies: Growing healthcare infrastructures in Asia-Pacific and Latin America widen distribution channels.
• Strategic Mergers & Acquisitions: Consolidation among key manufacturers to bolster R&D and market share.

Financial Trajectory

Revenue Growth & Investment Outlook

The combined markets for these compounds are projected to generate revenues exceeding USD 5 billion by 2028, with PEG 3350 and potassium chloride constituting the largest segments. Investment flows are increasingly directed toward:

• Research & Development: Focused on improving safety profiles and bioavailability.
• Manufacturing Expansion: Upgrading facilities to meet regulatory standards and increase capacity.
• Market Penetration Strategies: Tailoring OTC and prescription offerings to regional consumer needs.

Profitability and Cost Factors

Profit margins face pressure from raw material costs, regulatory compliance, and competitive pricing. Nonetheless, high-volume sales, especially in low-cost manufacturing regions, sustain profitability. Strategic economies of scale and process optimization are pivotal for maintaining positive financial trajectories.

Impact of Patent Expiry and Generic Competition

Many formulations within these categories are approaching or have entered patent expiration, leading to intensified generic competition. This trend reduces prices but simultaneously incentivizes innovation and formulation enhancements, paving pathways for new entrants or improved product lines.

Competitive Landscape

Major players include Perrigo, Bayer, Baxter International, and generic manufacturers from emerging markets. The crowded marketplace necessitates differentiated R&D, quality standards, and strategic partnerships to sustain growth.

Regulatory & Policy Impacts

Regulations enacted by agencies such as the FDA, EMA, and regional health authorities significantly influence market trajectories. Emphasis on safety, traceability, and manufacturing audits can influence costs and time-to-market, affecting financial performance.

Forecasting Future Trends

The outlook indicates sustained growth with potential accelerations driven by technological innovations, expanding markets in developing countries, and evolving regulatory landscapes. Companies investing in R&D and supply chain resilience are poised to capitalize on these dynamics.

Key Takeaways

• Strategic positioning in emerging markets offers significant growth opportunities amid escalating global health issues.
• Innovation in formulation and delivery methods can differentiate products and command premium pricing.
• Monitoring regulatory landscapes is critical to anticipate market entry barriers and compliance costs.
• Cost management and supply chain resilience are vital to sustain profitability, especially against generic competition and raw material fluctuations.
• Collaborative R&D efforts can accelerate product development, aligning with evolving consumer and regulatory needs.

FAQs

1. What are the primary factors influencing the demand for polyethylene glycol 3350?
   The aging population, increasing gastrointestinal disorder diagnoses, and OTC product accessibility drive demand for PEG 3350.

2. How does the rise in cardiovascular diseases affect the potassium chloride market?
   The growing prevalence necessitates electrolyte replenishment, fueling prescription and OTC sales of potassium chloride.

3. What challenges do manufacturers face with sodium bicarbonate formulations?
   Regulatory safety standards and competition from alternative therapies pressurize margins; innovation in delivery is essential.

4. How does generic drug competition impact market profitability for these compounds?
   Patent expirations lead to price reductions and heightened competition, compressing profit margins but also stimulating product improvements.

5. What regional trends are emerging for these ingredients in non-Western markets?
   Rapid healthcare infrastructure development and regulatory reforms in Asia-Pacific and Latin America expand market opportunities.

References

1. Industry Market Reports. (2022). Global Pharmaceuticals Market Analysis.
2. Research and Markets. (2022). Digestive and Electrolyte Market Forecasts.
3. PR Newswire. (2022). Regulatory Trends in OTC Pharmacology.
4. Zion Market Research. (2022). Chemical Compounds in Pharmacology: Market Trends.
5. Statista. (2022). Market Size and Segment Growth in the Pharmaceutical Industry.