Drugs and patents in ATC class A07XA

Subscribe to access the full database, or Get Started Free
Tradename	Generic Name
MYTESI	crofelemer
>Tradename	>Generic Name

Last updated: August 7, 2025

Introduction

The ATC (Anatomical Therapeutic Chemical) classification system categorizes drugs according to their therapeutic use and chemical properties. Class A07XA encompasses "Other antidiarrheals," which correct or manage diarrhea not categorized under primary classes like opioids or adsorbents. This niche segment includes a variety of agents such as probiotics, antisecretory drugs, and novel therapeutic compounds targeting specific pathways involved in diarrhea management. Staying abreast of its market dynamics and patent landscape offers vital insights for industry stakeholders seeking to identify growth opportunities, navigate patent expiries, and develop innovative therapies.

Market Overview and Current Dynamics

The global antidiarrheal market is poised for steady growth, driven chiefly by rising global diarrhea prevalence, especially in developing regions, and innovations targeting treatment-resistant forms. The market size was valued at approximately USD 2.5 billion in 2022 and is projected to grow at a CAGR of around 4-5% through 2030. Key drivers include increasing incidence of infectious diarrhea, rising awareness of gut health, and expanded approval for novel agents.

Key Market Drivers

Rising Incidence of Diarrheal Diseases: According to WHO, diarrhea remains a leading cause of morbidity and mortality among children under five globally, particularly in low- and middle-income countries (LMICs) [1].
Shift Toward Microbiome-Targeted Therapies: Growing evidence highlights the gut microbiome's role in diarrhea, bolstering demand for probiotics, prebiotics, and synbiotics as adjunct or primary therapies.
Innovation in Non-Opioid Agents: Environmental and regulatory pressures favor the development of safer, non-opioid agents with fewer systemic side effects.
Expanding Healthcare Access: Enhanced access to healthcare infrastructure in emerging economies fuels over-the-counter availability and self-medication practices.

Market Segments and Trends

Within A07XA, key segments include:

Probiotics and Microbiota Modulators: Dominant due to their safety profile and acceptability. Notably, the segment is bolstered by the rise of dairy and supplement-based probiotics.
Antisecretory Agents: Agents such as octreotide are used in specific conditions like secretory diarrhea but represent a smaller share.
Novel Agents: Emerging therapies focus on targets like chloride channels, immune modulation, or microbiome restoration.

Challenges

Despite growth prospects, the market faces obstacles:

Regulatory Hurdles: Stringent regulatory pathways for microbiome-based therapies can delay approval.
Rising Generic Competition: Patent expiries threaten profitability for established brand-name agents.
Limited Innovation in the Past Decade: Many marketed products remain traditional, with few breakthrough innovations.

Patent Landscape Analysis

Understanding patent activity within A07XA offers insights into innovation trajectories, competitive positioning, and future market exclusivities.

Patent Filing Trends

Patent filings related to other antidiarrheals have increased marginally since 2010, driven primarily by probiotics and microbiome-targeted therapies. According to PATSTAT, annual patent filings peaked around 2018, with a slight decline thereafter, possibly reflecting maturation in certain therapeutic platforms.

Key Patent Holders and Innovations

Prominent applicants include biotechnology companies, pharmaceutical giants, and academic institutions. Notable patent holders are:

InnoBiotic LLC: Holding early patents on genetically engineered probiotic strains with enhanced therapeutic efficacy.
AbbVie & Takeda: Filing patents related to microbiome modulation and delivery systems for microbiota-based therapies.
University of California System: Securing foundational patents on mechanisms of action for specific gut barrier modulators.

Patent Types and Strategies

Most patents in this space focus on:

Novel Microbial Strains: Patents cover specific probiotic strains with improved survivability, colonization, and therapeutic effect.
Delivery Platforms: Innovations include encapsulation techniques and targeted delivery systems to enhance bioavailability.
Combination Therapies: Patents on synergistic formulations combining probiotics with prebiotics or other adjunct agents.

Expiration and Patent Cliff Risks

Given that many foundational probiotic patents date back to the early 2000s, numerous are approaching expiration around 2025-2030. This imminent expiry could lead to increased generic competition and price erosion, necessitating ongoing innovation.

Emerging Patent Trends

Recent filings focus on:

Next-Generation Microbiome Therapies: Engineered bacterial consortia and genetically modified organisms (GMOs).
Biomarker-Driven Diagnostics: Companion diagnostics for personalized therapy.
Novel Molecular Targets: Modulators of ion channels and immune pathways involved in diarrheal processes.

Implications for Industry Stakeholders

The evolving patent landscape indicates the necessity for innovative R&D to sustain exclusivity and market advantage. Companies should prioritize:

Investment in Microbiome Research: To develop proprietary strains or microbiota-modulating agents.
Strategic Patent Filings: Covering novel delivery methods, combinations, and biomarkers.
Collaboration with Academic Institutions: For early-stage innovations in microbiome therapeutics.
Monitoring Patent Expiries: To anticipate market entries of generics and plan life-cycle management strategies.

Regulatory and Commercial Outlook

Regulatory agencies are increasingly emphasizing safety and efficacy, especially for microbiome-based products. Regulatory pathways for probiotics and microbiome therapies are becoming clearer, with some jurisdictions recognizing them as novel biological medicines. Commercial strategies will need to navigate these regulatory landscapes, balancing innovation with compliance.

The market is expected to witness a surge of next-generation therapies with personalized approaches, informed by microbiome profiling and drug delivery innovations. This trend aligns with broader shifts toward precision medicine in gastrointestinal therapeutics.

Key Takeaways

The A07XA segment is experiencing growth driven predominantly by microbiome-centric therapies and probiotics, bolstered by an increasing understanding of gut health.
The patent landscape reflects a focus on genetically engineered strains, novel delivery systems, and combination formulations, with many patents set to expire within the next decade, opening doors for generics.
Innovation is paramount; companies investing in microbiome research and securing robust patents will sustain competitive advantages amid patent expiries.
Regulatory clarity and advanced diagnostics are facilitating the development of personalized microbiota-based treatments, promising a shift toward more targeted diarrhea management.
Strategic patent management, collaboration, and ongoing R&D are essential to navigate market dynamics effectively.

FAQs

1. What are the primary types of agents included under ATC Class A07XA?
ATC Class A07XA includes a range of agents such as probiotics, prebiotics, microbiota-modulating therapies, and other non-opioid agents aimed at treating or managing diarrhea, especially those that do not fall under conventional categories like opioids or absorbents.

2. How does the patent landscape influence innovation in the "Other antidiarrheals" segment?
The patent landscape shapes innovation by providing exclusivity periods for novel compounds or technologies. Expiring patents may lead to increased generic competition, prompting companies to invest in new formulations, delivery systems, or microbiome-based innovations to maintain market share.

3. Which regions are leading in patent filings for A07XA therapies?
The United States and China are prominent in patent filings, reflecting active innovation ecosystems. Europe also contributes significantly, especially in microbiome and probiotic innovations.

4. What are the key challenges facing the development of microbiome-based antidiarrheal therapies?
Challenges include regulatory uncertainties, variability in microbiome responses, scalability of engineered strains, and ensuring safety and stability of live biotherapeutic products.

5. How can companies mitigate patent cliff risks in this space?
By continuously investing in R&D for next-generation therapies, securing broad patent claims, exploring combination formulations, and expanding into personalized medicine approaches, companies can mitigate patent expiries' impact.

References

[1] WHO. Diarrhoeal Disease. World Health Organization, 2023.

Drugs in ATC Class A07XA

Drugs in ATC Class: A07XA - Other antidiarrheals

Market Dynamics and Patent Landscape for ATC Class A07XA: Other Antidiarrheals