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POLYETHYLENE GLYCOL 3350 - Generic Drug Details

What are the generic drug sources for polyethylene glycol 3350 and what is the scope of patent protection?

Polyethylene glycol 3350 is the generic ingredient in twenty-two branded drugs marketed by Lannett Co Inc, Bayer Healthcare Llc, Ani Pharms, Annora Pharma, Aurobindo Pharma Ltd, Breckenridge Pharm, Elysium, Lgm Pharma, Mylan, Nexgen Pharma Inc, Novel Labs Inc, Nuvo Pharms Inc, Paddock Llc, Ppi-dac, Strides Pharma, Teva Pharms, L Perrigo Co, Braintree, Nostrum Labs Inc, Rising, Aurobindo Pharma Usa, Hospira, Norvium Bioscience, Vintage Pharms, Dynapharm, E Z Em, Goldline, and Sandoz, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for polyethylene glycol 3350. Sixty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for POLYETHYLENE GLYCOL 3350

US Patents:	0
Tradenames:	22
Applicants:	28
NDAs:	41
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	65
Raw Ingredient (Bulk) Api Vendors:	218
Clinical Trials:	305
What excipients (inactive ingredients) are in POLYETHYLENE GLYCOL 3350?	POLYETHYLENE GLYCOL 3350 excipients list
DailyMed Link:	POLYETHYLENE GLYCOL 3350 at DailyMed

See drug sales revenues for POLYETHYLENE GLYCOL 3350

Recent Clinical Trials for POLYETHYLENE GLYCOL 3350

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

Sponsor	Phase
University Hospitals Cleveland Medical Center	Phase 4
Changchun GeneScience Pharmaceutical Co., Ltd.	Phase 1
Jinling Hospital, China	N/A

See all POLYETHYLENE GLYCOL 3350 clinical trials

Generic filers with tentative approvals for POLYETHYLENE GLYCOL 3350

Applicant	Application No.	Strength	Dosage Form
		2MG; 5MG	SOLUTION; ORAL AND TABLET; DELAYED RELEASE

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for POLYETHYLENE GLYCOL 3350

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Stimulation Large Intestine Fluid/Electrolyte Secretion

US Patents and Regulatory Information for POLYETHYLENE GLYCOL 3350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nuvo Pharms Inc	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	206105-001	Oct 28, 2016		OTC	No	No
Novel Labs Inc	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	091077-001	Oct 6, 2009		OTC	No	No
Bayer Healthcare Llc	MIRALAX	polyethylene glycol 3350	FOR SOLUTION;ORAL	022015-001	Oct 6, 2006		OTC	Yes	Yes
Strides Pharma	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	203928-001	Aug 24, 2016		OTC	No	No
Nexgen Pharma Inc	POLYETHYLENE GLYCOL 3350	polyethylene glycol 3350	FOR SOLUTION;ORAL	077706-001	Sep 27, 2006		DISCN	No	No

POLYETHYLENE GLYCOL 3350 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Polyethylene Glycol 3350

Introduction

Polyethylene glycol 3350 (PEG 3350) is a versatile polymer with a wide range of applications, particularly in the healthcare sector. This article delves into the market dynamics and financial trajectory of PEG 3350, highlighting its growth drivers, challenges, and future outlook.

Market Size and Growth

The global PEG 3350 market is poised for significant growth. It is estimated to reach USD 3.09 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.29% during the forecast period[1].

Regional Market Analysis

Asia-Pacific Region

The Asia-Pacific region is the fastest-growing market for PEG 3350, driven by an increasing geriatric population, adoption of sedentary lifestyles, and rising prevalence of colorectal cancer. These factors contribute to a higher demand for PEG 3350 in this region[1].

Developing Economies

Developing economies present opportunities for the PEG 3350 market due to their growing R&D sectors and improving healthcare infrastructure. However, economic constraints in these regions can slow the growth of the healthcare industry, affecting the market's overall expansion[1].

Product Type and Market Share

Powder Segment

The powder form of PEG 3350 held the largest market share in 2022, accounting for approximately 62.84% of the market. This dominance is due to the ease of use and versatility of the powder form in various medical applications[1].

Applications and Uses

Healthcare Sector

PEG 3350 is widely used in the healthcare sector, particularly for treating constipation and preparing patients for colonoscopy procedures. Its efficacy in managing idiopathic constipation is well-documented, with studies showing that PEG 3350 plus electrolytes (PEG+E) is more effective and cost-efficient than lactulose[2].

Pharmaceutical Industry

In the pharmaceutical industry, PEG 3350 acts as an inactive ingredient, serving as a wetting and thickening agent in ointments, creams, and tablets. It also enhances the solubility and bioavailability of weakly water-soluble drugs[4].

Economic Impact

Cost-Effectiveness

A study from the UK's National Health Service (NHS) highlighted that using PEG+E instead of lactulose reduces the expected 3-monthly NHS cost by £11 per patient. Additionally, PEG+E doubles the percentage of patients successfully treated at 3 months, making it a more cost-effective option[2].

Resource Utilization

The economic impact of PEG 3350 extends beyond drug acquisition costs. General practitioner visits and district nurse domiciliary visits are significant cost drivers. However, the overall cost management is more efficient with PEG+E compared to lactulose[2].

Market Drivers

Increasing Prevalence of Colorectal Cancer

The rising prevalence of colorectal cancer, especially in regions like India and the Middle East, drives the demand for PEG 3350. This trend is expected to continue, contributing to market growth[1].

Aging Population

An increasing aging population globally creates lucrative opportunities for PEG 3350 manufacturers. Older adults are more prone to constipation and other gastrointestinal issues, increasing the need for effective treatments like PEG 3350[1].

Sedentary Lifestyle and Physical Inactivity

The adoption of sedentary lifestyles and physical inactivity among the population contributes to higher rates of constipation and other health issues, further boosting the demand for PEG 3350[1].

Market Challenges

Competition from Alternative Products

Despite the growth potential, the PEG 3350 market faces competition from alternative products. This competition can hamper market growth, making it essential for manufacturers to focus on product differentiation and efficacy[1].

Regulatory Framework

USP Standards

The United States Pharmacopeia (USP) has revised the monograph for PEG 3350 to widen the specification for formaldehyde and acetaldehyde, ensuring the quality and safety of PEG 3350 in drug products[5].

Future Outlook

Global Market Projections

The global polyethylene glycol market, which includes PEG 3350, is expected to reach USD 8,025.05 million by 2030, growing at a CAGR of 6.4% during the forecast period. This growth is driven by increasing demand in the pharmaceutical and healthcare sectors[4].

Emerging Markets

Developing economies will continue to offer growth opportunities as their healthcare infrastructure improves and the demand for effective treatments increases. Manufacturers are likely to expand their reach in these regions to capitalize on the growing market[1].

Key Takeaways

• The global PEG 3350 market is projected to reach USD 3.09 billion by 2032, growing at a CAGR of 6.29%.
• The Asia-Pacific region is the fastest-growing market due to an aging population and rising prevalence of colorectal cancer.
• PEG 3350 is cost-effective and more efficacious than alternatives like lactulose in treating constipation.
• The market faces competition from alternative products but is driven by an increasing aging population and sedentary lifestyles.
• Regulatory standards, such as those set by the USP, ensure the quality and safety of PEG 3350.

FAQs

Q: What is the expected market size of PEG 3350 by 2032?

A: The global PEG 3350 market is estimated to reach USD 3.09 billion by 2032[1].

Q: Which region is the fastest-growing market for PEG 3350?

A: The Asia-Pacific region is the fastest-growing market for PEG 3350, driven by an aging population and rising prevalence of colorectal cancer[1].

Q: What are the primary applications of PEG 3350 in the healthcare sector?

A: PEG 3350 is primarily used for treating constipation and preparing patients for colonoscopy procedures. It also serves as a wetting and thickening agent in pharmaceutical formulations[2][4].

Q: How does PEG 3350 compare to lactulose in terms of cost and efficacy?

A: PEG 3350 plus electrolytes (PEG+E) is more cost-effective and efficacious than lactulose, reducing NHS costs and doubling the percentage of successfully treated patients[2].

Q: What regulatory standards govern the quality of PEG 3350?

A: The United States Pharmacopeia (USP) sets standards for PEG 3350, ensuring its quality and safety in drug products[5].

Sources

1. Market Research Future: PEG 3350 Market Trends, Growth, Forecast 2032 | MRFR
2. PubMed: Economic impact of low dose polyethylene glycol 3350 plus electrolytes compared with lactulose in the treatment of idiopathic constipation
3. Biospace: Macrogol/Polyethylene Glycol (PEG) Market Growth 2022-2030
4. Data Bridge Market Research: Polyethylene Glycol Market Size, Outlook, & Industry Trends By 2030
5. USP-NF: Polyethylene Glycol 3350 - USP-NF