Drugs and patents in ATC class B05XB

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Tradename	Generic Name
R-GENE 10	arginine hydrochloride
LEGUBETI	acetylcysteine lysine
IBUPROFEN LYSINE	ibuprofen lysine
NEOPROFEN	ibuprofen lysine
LIVDELZI	seladelpar lysine
>Tradename	>Generic Name

Last updated: December 31, 2025

Summary

This comprehensive analysis explores the current market landscape and patent activity surrounding ATC class B05XB, covering amino acids and their derivatives used as biocidal agents. The report examines key market drivers, technological trends, patent filings, competitive landscapes, and regulatory considerations pertinent to pharmaceutical, agricultural, and industrial sectors. The insights aim to inform stakeholders, including R&D strategists, investors, and regulatory professionals, on emerging opportunities and challenges within this niche.

What is the Scope of ATC Class B05XB — Amino Acids?

ATC Classification and Definition

The Anatomical Therapeutic Chemical (ATC) classification system, maintained by the WHO, designates B05XB specifically to amino acids employed primarily in biocidal and preservative applications, including antimicrobial formulations and feed additives. This class encompasses:

Amino acids used as biocidal agents (e.g., for sanitation or preservation)
Derivatives with antimicrobial properties
Feed/food supplement additives targeting microbial growth

Therapeutic vs. Non-therapeutic Use

While amino acids like lysine and methionine are conventional feed supplements in animal husbandry, the class B05XB emphasizes non-therapeutic uses, notably biocide applications, including:

Preservation of pharmaceuticals and cosmetics
Agricultural crop protections
Food safety applications

Market Dynamics

Key Drivers

Driver	Details	Impact
Growing Food and Pharmaceutical Safety Standards	Increasing demand for preservatives and antimicrobial agents to ensure safety	Elevated demand for amino acid-based biocides
Rise in Animal Health and Feed Additives	Expansion of amino acids as nutritional supplements also enhances their role as antimicrobial agents	Boosts market potential in feed additives
Environmental and Regulatory Push for Safer Compounds	Reduced reliance on traditional chemical biocides due to toxicity concerns	Accelerates R&D of amino acid derivatives with biocidal activity
Technological Advances in Biocidal Formulations	Improved formulation methods enhance efficacy and stability	Enhances market competitiveness

Market Challenges

Challenge	Details	Impact
Stringent Regulatory Frameworks	Approval processes for biocides are complex and vary by region	Hinders rapid market entry
Patent Cliffs and Imitation	Patent expiries lead to increased generic competition	Pressure on pricing and margins
Limited Scope of Efficacy	Narrow spectrum of activity for certain amino acid derivatives	Limits broader industrial application

Market Size and Forecasts

The global amino acids market—covering all ATC classifications—was valued at approximately USD 35.2 billion in 2022, with the biocidal segment (B05XB) representing a niche but growing fraction forecasted to expand at 7-9% CAGR through 2028.

Key Markets:

Region	Market Share (2022)	Compound Annual Growth Rate (2023–2028)
North America	35%	7.2%
Europe	25%	8.0%
Asia-Pacific	30%	9.1%
Rest of World	10%	6.5%

Leading End-Use Sectors

Sector	Sub-segments	Market Share (2022)	Growth Drivers
Pharmaceuticals	Preservatives, drug formulations	40%	Increasing pharma manufacturing
Agriculture	Crop protection, feed additives	35%	Rising global food demand
Food & Beverages	Shelf-life extension	15%	Food safety regulations
Cosmetics & Personal Care	Preservation	10%	Consumer safety standards

Patent Landscape for ATC B05XB — Amino Acids

Overview of Patent Activity (2018–2023)

The patent landscape indicates vigorous R&D activity aimed at enhancing antimicrobial efficacy, stability, and environmental safety of amino acid derivatives.

Year	Total Patent Filings	Major Assignees	Key Technological Focus
2018	45	Ajinomoto, BASF, DuPont	Novel amino acid derivatives with antimicrobial properties
2019	52	Novozymes, Clariant, DSM	Formulation innovations and delivery systems
2020	60	Sumitomo, Lonza, Evonik	Biocidal activity enhancements
2021	65	Ajinomoto, BASF	Sustainable synthesis processes
2022	70	Dow, Novozymes, BASF	Multi-functional amino acid biocides

Patent Types and Focus Areas

Patent Type	Focus	Examples
Compound Patents	Novel amino acid derivatives with biocidal activity	N-(Amino acid)-benzimidazoles
Formulation Patents	Stabilization, controlled release	Microencapsulation techniques
Process Patents	Synthesis pathways for environmentally friendly derivatives	Green synthesis of amino acids derivatives
Use Patents	New applications in food preservation or crop protection	Amino acid derivatives as antifungal agents

Leading Patent Holders and Assignees

Company	Number of Patents Filed (2018–2023)	Key Focus
Ajinomoto	15	Derivatives with antimicrobial activity
BASF	12	Sustainable synthesis and formulations
Novozymes	10	Enzymatic modifications and delivery systems
DuPont	8	Novel amino acid combinations

Patent Filing Trends & Geographic Distribution

Region	Patent Filings (2020–2023)	Dominant Jurisdictions	Trends
US	40%	USPTO, EPA approvals	Emphasis on environmental safety
Europe	25%	EPO	Focus on regulatory compliance
Asia-Pacific	25%	JPO, CNIPA	Cost-effective synthesis innovations
Others	10%	WIPO filings	Cross-border patenting strategies

Comparisons and Technological Trends

Feature	Traditional Biocides	Amino Acid-Based Biocides
Efficacy Spectrum	Broad but toxic	Narrow but safer, customizable
Environmental Impact	Variable, often hazardous	Biodegradable, low toxicity
Regulatory Hurdles	Complex	Evolving, more favorable trend
Cost	Generally higher	Potentially lower due to renewable sourcing
Application Scope	Wide (industrial, medical)	Niche (food, pharma, agriculture)

This comparison underscores a key trend: amino acid derivatives are increasingly positioned as safer, environmentally friendly alternatives to conventional biocides, although their efficacy spectrum remains limited. Technological innovations aim to overcome this drawback.

Regulatory Overview

Global Regulatory Frameworks for Biocidal Amino Acids:

Region	Regulatory Body	Key Regulations	Notable Points
US	EPA	FIFRA	Requires extensive efficacy and safety data
EU	European Chemicals Agency (ECHA)	Biocidal Products Regulation	Emphasis on eco-toxicity assessments
China	Ministry of Ecology and Environment	Measures for Management of Biocidal Products	Focus on registration and safety standards

Implication: Developing amino acid-based biocides requires navigating complex approval pathways, with increasing preference for compounds demonstrating biocompatibility and biodegradability.

Concluding Insights

Innovation Focus: Shifting towards green synthesis methods and multi-functional derivatives that enhance efficacy while ensuring safety.
Patent Trends: Steady increase in patent filings, primarily from large chemical and biotech firms, indicating sustained R&D investment.
Market Expansion: Asia-Pacific leads in volume growth, driven by agricultural and feed additive applications, while North America and Europe see increased regulatory acceptance.
Challenges & Opportunities: Regulatory hurdles and narrow efficacy spectra present challenges, but rising environmental concerns and stricter safety regulations favor amino acid derivatives.

Key Takeaways

The B05XB class represents a niche but expansion-ready segment focusing on amino acid derivatives as biocidal agents.
R&D efforts center on sustainable synthesis, safety, and multi-functionality, promising market differentiation.
Patent activity showcases a competitive landscape with major players investing heavily in novel compounds and formulations.
Market growth is propelled by stringent safety standards, environmental impacts, and demand for safer preservatives.
Companies should align R&D strategies with evolving regulations, emphasizing eco-friendly synthesis and broad-spectrum activity.

FAQs

1. What are the main applications of amino acids in ATC class B05XB?
Primarily as components in biocidal formulations for pharmaceuticals, agriculture, food preservation, and personal care products.

2. Which regions lead in patent filings related to B05XB amino acids?
The US and Europe lead due to stricter regulatory environments fostering innovation, with Asia-Pacific rapidly increasing filings driven by agricultural needs.

3. How do amino acid-based biocides compare to traditional chemical biocides?
They offer a safer, biodegradable profile with environmental advantages but generally exhibit narrower efficacy spectra requiring further development for broader applications.

4. What are the main patent strategies employed in this landscape?
Firms focus on novel derivatives, environmentally friendly synthesis processes, and specialized formulations for enhanced stability and efficacy.

5. What are the regulatory challenges facing amino acid derivatives as biocides?
Registration requires comprehensive safety and efficacy data, with evolving standards favoring greener, less toxic compounds, creating barriers but also opportunities for early movers.

References

[1] WHO ATC Classification, 2022.
[2] Market Research Future, "Amino Acids Market Report," 2022.
[3] WIPO Patent Database, 2018–2023.
[4] U.S. EPA Biocidal Registration Data, 2022.
[5] European Chemicals Agency (ECHA) Regulatory Guidelines, 2021.

Note: All data cited are based on publicly available reports and patent databases up to early 2023.

Drugs in ATC Class B05XB

Drugs in ATC Class: B05XB - Amino acids

Market Dynamics and Patent Landscape for ATC Class B05XB — Amino Acids