Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride - Generic Drug Details

What are the generic drug 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, Azurity, 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
Strides Pharma	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride	FOR SOLUTION;ORAL	204559-001	Apr 13, 2015	AA	RX	No	No
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
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
Goldline	GLYCOPREP	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SUSPENSION;ORAL	072319-001	Dec 23, 1988		DISCN	No	No
Azurity	GOLYTELY	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	019011-002	Jun 2, 1992		DISCN	Yes	No

Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for the Drug Combination of Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride?

The combination of polyethylene glycol 3350 (PEG 3350), potassium chloride, sodium bicarbonate, and sodium chloride is primarily employed in bowel preparation for colonoscopy procedures. The global market for this drug class is influenced by several factors.

Market Drivers

1. Growing Prevalence of Gastrointestinal Disorders
   The rise in colorectal cancer incidence and gastrointestinal diseases increases demand for diagnostic procedures, boosting need for bowel prep solutions.

2. Expanding Screening Programs
   Governments and healthcare organizations worldwide emphasize colonoscopies, especially in screening protocols starting at age 45–50, driving higher utilization of bowel cleansing agents.

3. Patient Preference for Oral Powder Formulations
   The preference for oral powders over invasive alternatives enhances adherence, supporting sales growth.

4. Regulatory Approvals and Product Launches
   Continued approvals and new formulations enhance market presence. For example, in 2020, the FDA approved various bowel prep products incorporating this combination.

Market Restraints

• Side Effects and Tolerability Issues
  Gastrointestinal distress and electrolyte imbalances associated with PEG-based solutions limit their use in some patient populations.

• Availability of Alternatives
  Other bowel prep regimens like sodium phosphate-based agents or low-volume solutions compete on efficacy and tolerability.

• Cost Factors
  The expense of branded products influences adoption in emerging markets.

Market Size & Forecast

• The global bowel cleansing market was valued at approximately $1.2 billion in 2022.
• Compound annual growth rate (CAGR) estimates range from 5% to 7% during 2023–2028.
• The Asia-Pacific region shows the fastest growth, attributed to increasing healthcare spending and urbanization.

Competitive Landscape

Major pharmaceutical companies, including Ferring Pharmaceuticals, Olympus, and Takeda Pharmaceuticals, lead the market, offering products like MoviPrep, PicoSalax, and other PEG-based solutions. Patent expirations are expected to influence market share redistribution.

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What Is the Financial Trajectory of This Drug Combination?

Revenue Projections and Trends

• Historical Revenue
  Sales of bowel prep agents using the PEG 3350- potassium chloride, sodium bicarbonate, and sodium chloride combination have expanded steadily through new product entries and increased screening.

• Forecasted Growth
  Market analysts project revenues reaching approximately $1.7 billion by 2028, with CAGR around 6%, based on increased screening rates and new formulations.

Key Financial Indicators

Year	Estimated Market Size (USD)	Growth Rate (%)
2022	1.2 billion	—
2023	1.27 billion	5.8%
2024	1.35 billion	6.3%
2025	1.43 billion	6.0%
2026	1.52 billion	6.0%
2027	1.61 billion	5.9%
2028	1.70 billion	5.6%

Profitability and Investment Outlook

• Margins are variable depending on formulation costs, patent status, and competition.
• R&D investments focus on improving tolerability, reducing electrolyte Imbalances, and developing targeted formulations.
• Mergers and acquisitions are common as companies seek market share expansion capabilities.

Regulatory and Patent Impact

• Patent expirations for key products starting 2024 may lead to generic competition, impacting prices and margins.
• Stringent regulatory requirements, especially regarding safety and electrolyte management, may influence R&D expenses and time-to-market.

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What Are the Key Drivers and Restraints Shaping Future Trends?

• Drivers: Increasing colorectal cancer screening, innovations in drug formulation to enhance tolerability, and expanding healthcare access in emerging markets.

• Restraints: Safety concerns related to electrolyte disturbances, increased competition, and pricing pressures from generics.

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Key Takeaways

The market for bowel preparation solutions comprising polyethylene glycol 3350; potassium chloride; sodium bicarbonate; and sodium chloride is poised for steady growth through 2028. Drivers include rising screening rates and patient preference; restraints revolve around safety and competition. Financial trajectories suggest revenues expanding from $1.2 billion in 2022 to around $1.7 billion in 2028, with profits susceptible to patent expirations and regulatory developments.

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FAQs

1. What are the primary indications for drugs containing this combination?
   They are used for bowel cleansing before colonoscopy procedures to remove fecal matter and improve visualization.

2. How do safety concerns affect market growth?
   Electrolyte imbalances and gastrointestinal side effects restrict use in certain populations, potentially limiting market expansion.

3. Which regions lead in market adoption?
   North America, Europe, and emerging Asia-Pacific markets show high adoption, driven by screening programs and healthcare infrastructure.

4. What impact will patent expiries have on market competition?
   Patent expiries starting around 2024 could lead to increased generic competition, reducing prices and profit margins.

5. Are new formulations expected to influence the market?
   Yes, innovations focusing on improved tolerability, reduced side effects, and easier administration are anticipated to stimulate revenue growth.

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Sources

[1] Markets and Markets. "Bowel Preparation Market," 2022.
[2] IQVIA. "Global Gastrointestinal Drugs Market Analysis," 2023.
[3] U.S. Food & Drug Administration. "Regulatory Approvals for Bowel Prep Agents," 2020.
[4] Mordor Intelligence. "Gastrointestinal Drugs Market," 2023.

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(Note: All data are estimates based on publicly available reports and may vary with actual market conditions.)