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Last Updated: December 22, 2024

PEG-LYTE Drug Patent Profile


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When do Peg-lyte patents expire, and what generic alternatives are available?

Peg-lyte is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in PEG-LYTE is polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous. There are four hundred and twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous profile page.

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Summary for PEG-LYTE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 168
DailyMed Link:PEG-LYTE at DailyMed
Drug patent expirations by year for PEG-LYTE

US Patents and Regulatory Information for PEG-LYTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz PEG-LYTE polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous FOR SUSPENSION;ORAL 073098-001 Aug 31, 1993 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PEG-LYTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of PEGylated Drugs: A Comprehensive Overview

Introduction to PEGylated Drugs

PEGylated drugs, which involve the attachment of polyethylene glycol (PEG) to biomedical molecules, have been transforming the pharmaceutical industry by enhancing the pharmacokinetic and pharmacodynamic properties of various drugs. This process, known as PEGylation, improves the stability, solubility, and half-life of proteins, peptides, and small-molecule drugs, making them more effective and safer for patients.

Market Size and Growth Projections

The global PEGylated drugs market is experiencing significant growth, driven by advancements in drug delivery systems and increasing demand for more effective and safer therapeutic options.

  • The market is projected to grow from USD 8.16 billion in 2024 to USD 17.80 billion by 2032, exhibiting a compound annual growth rate (CAGR) that underscores the robust expansion of this sector[1].
  • Similarly, the PEGylation proteins market is expected to grow from USD 1.93 billion in 2023 to around USD 5.59 billion by 2033, with a CAGR of 11.2% from 2024 to 2033[3].

Key Drivers of Market Growth

Several factors are driving the growth of the PEGylated drugs market:

Technological Advancements

Technological advancements in drug delivery systems are a major driver. PEGylation enhances the stability and pharmacological properties of proteins, peptides, and small-molecule drugs, making them more effective and longer-lasting[3].

Increasing Pharmaceutical Research and Development

Global growth in pharmaceutical research and development is another significant factor. The emphasis on developing new and improved therapeutic agents has led to increased investment in PEGylation technologies[5].

Expanding Applications

PEGylated drugs are being used across a wide range of indications, including cancer, gout, hemophilia, and hepatitis. The cancer application segment, for instance, is poised to grow at a CAGR of 13.5% from 2024 to 2033[3].

Regional Analysis

The market for PEGylated drugs is geographically diverse, with different regions exhibiting varying growth patterns:

North America

North America holds a significant market share, driven by the presence of major pharmaceutical and biotechnology companies. The U.S. PEGylation proteins market is expected to reach around USD 1,460 million by 2033, growing at a CAGR of 11.9% from 2024 to 2033[3].

Europe

Europe is another lucrative region, anchored in its well-established pharmaceutical industry, stringent regulatory compliance, and robust healthcare infrastructure. The region's emphasis on research and development further contributes to its growth[5].

Asia-Pacific

The Asia-Pacific region is poised for rapid growth, driven by the burgeoning pharmaceutical sector, increasing healthcare investments, and a rapidly evolving market landscape[5].

Market Segmentation

The PEGylated drugs market is segmented based on several criteria:

By Molecule

  • Proteins
  • FAB’ Fragment
  • Enzyme
  • Aptamer

These segments are crucial as they cater to different therapeutic needs and have varying market shares and growth rates[1].

By Indication

  • Cancer
  • Gout
  • Hemophilia
  • Hepatitis

Each indication has its own set of challenges and opportunities, influencing the overall market dynamics[1].

By End User

  • Pharmaceutical & Biotechnology Companies
  • Research Institutions
  • Hospitals and Clinics

The pharmaceutical and biotechnology companies segment accounted for a revenue share of 42% in 2023, highlighting their dominant role in the market[3].

Financial Trajectory

The financial trajectory of the PEGylated drugs market is promising, with significant investments and revenue growth anticipated:

  • The global PEGylation proteins market is expected to reach around USD 5.59 billion by 2033, growing at a CAGR of 11.2% from 2024 to 2033[3].
  • The pharmaceutical grade polyethylene glycol (PEG) market is projected to reach USD 1,731.73 million by 2030, growing at a CAGR of 5.87% from 2024 to 2030[5].

Challenges and Opportunities

While the market is growing, there are challenges and opportunities to consider:

Challenges

  • Regulatory compliance and stringent approval processes can be barriers to entry and growth.
  • High development costs and the need for continuous innovation can be challenging for smaller players.

Opportunities

  • The expanding applications of PEGylated drugs across various therapeutic areas offer significant growth opportunities.
  • Technological advancements and collaborations between pharmaceutical companies and research institutions can drive innovation and market expansion.

Impact on Patient Care

PEGylated drugs have a profound impact on patient care by:

Enhancing Drug Stability and Half-Life

PEGylation improves the pharmacokinetic behavior of drugs, making them more stable and longer-lasting, which can lead to better patient outcomes[3].

Reducing Adverse Effects

For example, in bowel preparation products like Bi-PEGLYTE®, PEGylation can reduce adverse effects such as nausea, vomiting, and abdominal pain compared to traditional preparations[4].

Key Takeaways

  • The global PEGylated drugs market is projected to grow significantly, driven by technological advancements and increasing demand.
  • The market is segmented by molecule, indication, and end user, with pharmaceutical and biotechnology companies playing a dominant role.
  • Regional growth varies, with North America, Europe, and the Asia-Pacific region being key markets.
  • PEGylated drugs enhance drug stability, reduce adverse effects, and improve patient outcomes.

FAQs

What is PEGylation?

PEGylation is the process of attaching polyethylene glycol (PEG) to biomedical molecules to enhance their pharmacokinetic and pharmacodynamic properties.

What are the key applications of PEGylated drugs?

PEGylated drugs are used across various indications, including cancer, gout, hemophilia, and hepatitis.

What drives the growth of the PEGylated drugs market?

Technological advancements in drug delivery systems, increasing pharmaceutical research and development, and expanding applications are key drivers.

Which regions are leading the growth in the PEGylated drugs market?

North America, Europe, and the Asia-Pacific region are the leading markets, driven by their robust pharmaceutical industries and healthcare infrastructures.

How do PEGylated drugs impact patient care?

PEGylated drugs enhance drug stability and half-life, reduce adverse effects, and improve patient outcomes.

Sources

  1. Market Research Future: PEGylated Drugs Market Size, Share and Industry Analysis, 2032.
  2. Investopedia: Price/Earnings-to-Growth (PEG) Ratio: What It Is and the Formula.
  3. BioSpace: PEGylation Proteins Market Size to Worth Around US$ 5.59 Billion by 2033.
  4. Health Canada: bi-peglyte - [Product Monograph Template - Standard].
  5. Verified Market Research: Pharmaceutical Grade Polyethylene Glycol (PEG) Market Size And Forecast.

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