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Last Updated: December 22, 2024

Acetylcysteine lysine - Generic Drug Details


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What are the generic drug sources for acetylcysteine lysine and what is the scope of patent protection?

Acetylcysteine lysine is the generic ingredient in one branded drug marketed by Galephar and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for acetylcysteine lysine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
Patent Applications: 190
DailyMed Link:acetylcysteine lysine at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for acetylcysteine lysine
Generic Entry Date for acetylcysteine lysine*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
FOR SOLUTION;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for acetylcysteine lysine

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

SponsorPhase
Joel LavinePhase 1/Phase 2
Raptor Pharmaceuticals Corp.Phase 1/Phase 2

See all acetylcysteine lysine clinical trials

US Patents and Regulatory Information for acetylcysteine lysine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galephar LEGUBETI acetylcysteine lysine FOR SOLUTION;ORAL 215040-002 Feb 13, 2024 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Galephar LEGUBETI acetylcysteine lysine FOR SOLUTION;ORAL 215040-001 Feb 13, 2024 DISCN Yes 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

Acetylcysteine lysine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetylcysteine and Lysine

Introduction

The markets for acetylcysteine and lysine are dynamic and growing, driven by various factors including increasing health awareness, technological advancements, and expanding therapeutic applications. Here, we delve into the market dynamics and financial trajectories of these compounds.

Acetylcysteine Market Overview

Global Market Size and Growth

The global acetylcysteine market is substantial and growing rapidly. As of 2024, the market size was valued at USD 2.11 billion and is projected to reach around USD 14.69 billion by 2034, growing at a CAGR of 21.4% from 2024 to 2034[3].

Regional Market Share

North America dominates the acetylcysteine market, capturing a significant share due to the high prevalence of respiratory conditions such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis. The U.S. market alone was estimated at USD 480 million in 2023 and is expected to grow to USD 4,100 million by 2034 at a CAGR of 21.6%[3].

Application and Product Types

Acetylcysteine is used in various forms, including tablets, tracheal drips, and sprays. The spray segment is anticipated to witness rapid growth due to its convenience and effectiveness in managing respiratory conditions. Advances in spray technology have enhanced the efficacy of acetylcysteine sprays, making them a preferred choice for patients[3].

Therapeutic Applications

Acetylcysteine is widely used for treating acetaminophen overdose and as a mucolytic agent. Ongoing research explores its potential in treating liver failure, cancer, and other medical conditions, further expanding its therapeutic applications[3].

Lysine Market Overview

Global Market Size and Growth

The global lysine market was valued at USD 1.26 billion in 2023 and is expected to grow at a CAGR of 8.2% from 2024 to 2030. This growth is driven by the increasing demand for protein-rich diets and the critical role lysine plays in animal nutrition[1].

Regional Market Share

The Asia Pacific region holds the largest market share, accounting for 39.6% of the global lysine market in 2023. This is due to rapid urbanization and increasing meat consumption. North America and Europe also hold significant shares, driven by robust pharmaceutical infrastructure and the animal feed industry[1].

Applications in Animal Nutrition

Lysine is essential for enhancing livestock growth and meat quality, particularly in intensive livestock farming systems. Its supplementation in animal feed has significantly influenced the lysine market, especially in regions with high meat consumption[1].

Health and Wellness

Lysine is also valued for its health benefits in human diets, including collagen synthesis and calcium absorption. Health-conscious consumers are increasingly seeking lysine-rich foods, contributing to the demand in the food and beverage sector[1].

Market Drivers

Increasing Health Awareness

Both acetylcysteine and lysine markets are driven by increasing health awareness. Consumers are recognizing the importance of these compounds in their diets and for therapeutic purposes, leading to higher demand[1][3].

Technological Advancements

Innovations in production technology have enabled efficient manufacturing processes for both acetylcysteine and lysine. For acetylcysteine, advancements in spray technology have improved drug delivery mechanisms, while for lysine, innovations have enhanced its production and use in animal feed[1][3].

Expanding Therapeutic Applications

Acetylcysteine is being explored for new therapeutic applications, including liver failure and cancer treatment. Lysine, on the other hand, is seeing increased use in health and wellness products due to its role in collagen synthesis and calcium absorption[1][3].

Market Challenges

Logistical and Supply Chain Issues

The lysine market has faced challenges due to logistical issues and unpredictable consumer spending, leading to price surges. Similarly, the acetylcysteine market has been affected by the COVID-19 pandemic, although recovery is expected as the outbreak is controlled[1][4].

Competition

Both markets are highly competitive with numerous regional and international players. Companies like ADM, Evonik, and COFCO Biochemical in the lysine market, and various pharmaceutical companies in the acetylcysteine market, are investing in product innovation, facility expansion, and strategic partnerships to gain a competitive edge[1][3].

Financial Trajectory

Acetylcysteine

The financial trajectory for acetylcysteine is highly positive, with the market expected to grow from USD 2.11 billion in 2024 to USD 14.69 billion by 2034. This growth is driven by increasing demand for respiratory treatments and expanding therapeutic applications[3].

Lysine

The lysine market is also on a growth path, expected to grow at a CAGR of 8.2% from 2024 to 2030. The market value is projected to increase significantly due to the increasing demand for protein-rich diets and the critical role of lysine in animal nutrition[1].

Key Players and Strategies

Acetylcysteine

Key players in the acetylcysteine market are focusing on product innovation, expanding their product portfolios, and enhancing distribution channels. Strategic partnerships and investments in research and development are also key strategies to drive market growth[3].

Lysine

In the lysine market, companies are prioritizing product innovation, facility expansion, and distribution channel enhancement. Strategic partnerships and investments in efficient manufacturing processes are crucial for maintaining a competitive edge[1].

Future Outlook

Acetylcysteine

The future outlook for acetylcysteine is promising, with significant growth anticipated in the respiratory treatment segment. The expanding therapeutic applications and advancements in spray technology will continue to drive market growth[3].

Lysine

For lysine, the future looks bright with increasing demand from the animal feed industry and the health and wellness sector. Innovations in production technology and expanding product portfolios will contribute to the market's growth[1].

Illustrative Statistics

  • Acetylcysteine Market Size: Expected to reach USD 14.69 billion by 2034 from USD 2.11 billion in 2024[3].
  • Lysine Market Size: Valued at USD 1.26 billion in 2023, expected to grow at a CAGR of 8.2% from 2024 to 2030[1].
  • Regional Share: North America holds 39% of the acetylcysteine market, while the Asia Pacific holds 39.6% of the lysine market[1][3].

Quotes from Industry Experts

"The increasing prevalence of respiratory conditions and the expanding therapeutic applications are driving the acetylcysteine market forward." - Industry Analyst[3].

"Lysine's critical role in animal nutrition and its health benefits for humans are key factors in its market growth." - Market Researcher[1].

Key Takeaways

  • Growing Demand: Both acetylcysteine and lysine markets are driven by increasing demand for health and wellness products.
  • Technological Advancements: Innovations in production and delivery technologies are enhancing market growth.
  • Expanding Applications: Acetylcysteine is being explored for new therapeutic applications, while lysine is seeing increased use in health and wellness products.
  • Regional Dominance: North America dominates the acetylcysteine market, while the Asia Pacific leads in the lysine market.
  • Competitive Landscape: Both markets are highly competitive with key players focusing on innovation and strategic partnerships.

FAQs

1. What is the projected growth rate of the acetylcysteine market?

The acetylcysteine market is expected to grow at a CAGR of 21.4% from 2024 to 2034[3].

2. What are the primary applications of lysine?

Lysine is primarily used in animal nutrition to enhance livestock growth and meat quality, and in human diets for its health benefits such as collagen synthesis and calcium absorption[1].

3. Which region dominates the acetylcysteine market?

North America dominates the acetylcysteine market, capturing the largest market share due to the high prevalence of respiratory conditions[3].

4. How does technological advancement impact the lysine market?

Technological advancements in production processes have enabled efficient manufacturing of lysine, contributing to its market growth[1].

5. What are the future outlooks for the acetylcysteine and lysine markets?

Both markets are expected to grow significantly, driven by increasing demand for health and wellness products and expanding therapeutic applications[1][3].

Cited Sources:

  1. Grand View Research: Lysine Market Size, Share, Growth And Trends Report 2030[1].
  2. Department of Science and Technology: Molecular research shows path towards better treatment of kidney ailments[2].
  3. Precedence Research: Acetylcysteine Market Size, Share, Demand | CAGR Of 21.4%[3].
  4. SkyQuest: N-Acetylcysteine Market Report: Size, Share & Forecast | 2031[4].

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