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

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

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

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

US Patents:	0
Tradenames:	14
Applicants:	12
NDAs:	15
Clinical Trials:	1
DailyMed Link:	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE at DailyMed

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

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 clinical trials

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	PEG 3350 AND ELECTROLYTES	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	090928-001	Jan 28, 2010		DISCN	No	No
Novel Labs Inc	PEG 3350 AND ELECTROLYTES	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	090186-001	Jun 1, 2009		RX	No	No
Norvium Bioscience	COLYTE	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	018983-004	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
Novel Labs Inc	PEG 3350 AND ELECTROLYTES	polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous	FOR SOLUTION;ORAL	090231-001	Jun 1, 2009	AA	RX	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

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE Market Analysis and Financial Projection Experimental

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

Introduction

Polyethylene Glycol 3350 (PEG-3350) combined with electrolytes such as potassium chloride, sodium bicarbonate, and sodium chloride is a widely used formulation for bowel cleansing, particularly before colonoscopy. This article delves into the market dynamics and financial trajectory of this drug combination.

Market Overview

The market for bowel cleansing preparations is driven by the increasing need for colonoscopies, which are crucial for the early detection and prevention of colorectal cancer. PEG-3350 based solutions are among the most commonly prescribed due to their efficacy and safety profile.

Key Players and Market Share

The market for PEG-3350 based bowel cleansing solutions is dominated by several key players, including Novel Laboratories, Inc., and other pharmaceutical companies that manufacture similar formulations like TriLyte and NuLYTELY. These companies have a significant market share due to their established brands and extensive distribution networks[3][5].

Market Size and Growth

The global market for bowel cleansing preparations has been growing steadily, driven by an increase in the number of colonoscopies performed annually. The market size is expected to continue growing as the prevalence of colorectal cancer and other gastrointestinal disorders increases, particularly in aging populations.

Financial Performance

The financial performance of PEG-3350 based bowel cleansing solutions is robust, with these products generating substantial revenue for pharmaceutical companies. The cost-effectiveness and wide acceptance of these solutions contribute to their financial success. For instance, the average cost of a 4-liter jug of PEG-3350 with electrolytes is relatively affordable, making it a preferred choice for both patients and healthcare providers[3][5].

Pricing Strategies

Pricing strategies for PEG-3350 based solutions vary by region and are influenced by factors such as regulatory environments, competition, and reimbursement policies. Generally, these products are priced competitively to ensure market penetration while maintaining profitability.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of PEG-3350 based bowel cleansing solutions. These products are subject to strict FDA regulations, including post-marketing studies to assess systemic exposure and pharmacokinetics. Compliance with these regulations is essential for maintaining market approval and ensuring patient safety[2].

Clinical and Safety Data

The safety and efficacy of PEG-3350 based solutions are well-documented. These products are indicated for bowel cleansing in adults and pediatric patients aged 6 months or older. However, they must be used with caution in certain patient populations, such as those with severe ulcerative colitis or young children, where there is a risk of hypoglycemia and electrolyte imbalances[1][5].

Pharmacokinetics and Pharmacodynamics

The primary mode of action of PEG-3350 is through its osmotic effect, which retains water in the colon and produces a watery stool. The addition of electrolytes like sodium chloride, sodium bicarbonate, and potassium chloride helps maintain electrolyte balance during the bowel cleansing process. Minimal systemic absorption of PEG-3350 ensures that the solution is primarily eliminated in the feces, with absorbed portions appearing in the urine[2][5].

Competitive Landscape

The competitive landscape for bowel cleansing preparations is characterized by several FDA-approved products, including HalfLytely, NuLYTELY, and TriLyte. These products compete based on factors such as efficacy, safety profile, taste, and ease of administration. The market is also influenced by generic and branded versions of these formulations[3][5].

Future Outlook

The future outlook for PEG-3350 based bowel cleansing solutions is positive, driven by increasing demand for colonoscopies and the need for effective and safe bowel cleansing agents. Advances in formulation and administration methods, such as improved flavors and reduced volume preparations, are expected to further enhance market growth.

Challenges and Opportunities

Despite the positive outlook, there are challenges such as the need for ongoing post-marketing studies to ensure safety, particularly in pediatric populations. Opportunities exist in expanding the market through increased awareness and education about the importance of colonoscopies, as well as developing new formulations that address specific patient needs.

Key Takeaways

• Market Growth: The market for PEG-3350 based bowel cleansing solutions is growing due to increased demand for colonoscopies.
• Financial Performance: These products generate significant revenue due to their cost-effectiveness and wide acceptance.
• Regulatory Compliance: Strict FDA regulations must be adhered to, including post-marketing studies.
• Safety and Efficacy: Well-documented safety and efficacy profiles support their use in various patient populations.
• Competitive Landscape: The market is competitive with several FDA-approved products vying for market share.

FAQs

Q: What is the primary use of PEG-3350 with electrolytes? A: The primary use is for bowel cleansing prior to colonoscopy.

Q: What are the key ingredients in PEG-3350 based bowel cleansing solutions? A: The key ingredients include polyethylene glycol 3350, sodium chloride, sodium bicarbonate, and potassium chloride.

Q: How is the solution prepared? A: The solution is prepared by dissolving the powdered ingredients in 4 liters of water and shaking vigorously to ensure dissolution.

Q: What are the potential side effects of PEG-3350 based solutions? A: Potential side effects include diarrhea, dehydration, and electrolyte imbalances, particularly in young children and patients with severe ulcerative colitis.

Q: Are PEG-3350 based solutions safe for pediatric use? A: Yes, they are safe for pediatric use in children aged 6 months or older, but must be carefully monitored for possible hypoglycemia and electrolyte imbalances.

Cited Sources

1. Novel Laboratories, Inc. - PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution[1].
2. FDA - 203595Orig1s000 Clinical Pharmacology Review[2].
3. RxList - TriLyte Drug Information[3].
4. PubChem - Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride[4].
5. Drugs.com - PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution[5].