Drugs and patents in ATC class A07EC - Aminosalicylic acid and similar agents

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Tradename	Generic Name
AZULFIDINE	sulfasalazine
AZULFIDINE EN-TABS	sulfasalazine
SULFASALAZINE	sulfasalazine
S.A.S.-500	sulfasalazine
DIPENTUM	olsalazine sodium
BALSALAZIDE DISODIUM	balsalazide disodium
>Tradename	>Generic Name

Last updated: July 30, 2025

Introduction

The ATC (Anatomical Therapeutic Chemical) Classification System categorizes drugs into groups based on their therapeutic use and chemical characteristics. Class A07EC pertains specifically to aminosalicylic acid and similar agents, primarily used in managing tuberculosis (TB) and related infectious diseases. Over the past decade, market dynamics in this sector have evolved due to rising antimicrobial resistance, innovative drug development, and shifting regulatory landscapes. Understanding these factors, along with the patent landscape, is critical for stakeholders aiming to navigate this specialized niche effectively.

Market Overview

Historical Context and Current Market Size

Aminosalicylic acid (PAS), first discovered in the 1940s, has long been employed as a second-line agent for multi-drug resistant tuberculosis (MDR-TB). Despite being an established drug, the global TB market remains substantial, estimated to generate over $1.5 billion USD annually, with aminosalicylic acid constituting a key component in complex treatment regimens (WHO, 2022).

The demand for aminosalicylic acid and analogs remains concentrated in regions with high TB burden, namely India, China, Russia, and parts of Africa. Arrays of generic formulations dominate the landscape, though the market for innovative formulations or derivatives remains limited but gradually expanding.

Market Drivers

Rising Multidrug-Resistant Tuberculosis (MDR-TB): The increase in MDR-TB cases, estimated at around 400,000 globally in 2021, directly fuels demand for second-line agents, including aminosalicylic acid (WHO, 2022). The absence of new antibiotics has further cemented aminosalicylic acid’s role.
Emergence of Extensively Drug-Resistant TB (XDR-TB): XDR-TB cases have prompted utilizing existing drugs in novel combinations, sustaining market relevance.
Regulatory Endorsements and WHO Guidelines: The World Health Organization's (WHO) inclusion of aminosalicylic acid in standardized MDR-TB treatment regimens helps sustain demand and informs clinical practices.
Developments in Drug Delivery: Novel formulations aimed at improving bioavailability or reducing adverse effects may expand market reach.

Emerging Trends and Challenges

Antimicrobial Resistance (AMR): Although existing, there is concern about resistance development against aminosalicylic acid, emphasizing the need for new analogs.
Limited Innovation: The drug class is characterized by a paucity of publicly disclosed new chemical entities (NCEs), primarily due to the scientific challenges and limited profitability, especially outside high-burden nations.
Generic Competition: The patent expirations of several formulations have led to a proliferation of generic versions, intensifying price competition but also reducing margins for innovators.
Supply Chain Constraints: Manufacturing complexities and procurement policies influence global availability, particularly in resource-limited settings.

Patent Landscape Analysis

Primary Patent Holdings and Patent Expiry Timeline

Patent protection is fundamental to sustaining innovation financially. The patent landscape for aminosalicylic acid and its analogs reveals limited active patents in recent years, since most foundational patents expired decades ago (early 1980s). Our analysis indicates:

Initial Patents (1950s-1970s): Core chemical patents granted to original discoverers, now expired.
Secondary Patents (1980s-2000s): Focused on formulation improvements, methods of synthesis, and specific uses. These patents have largely expired or are close to expiry.
Recent Patent Filings (2010s onward): Focused on drug delivery systems, combination therapies, and biomarkers for resistance detection. However, most are either pending, have narrow claims, or are filed in specific jurisdictions (e.g., US, EU, China).

Innovations in Related Agents

Few high-profile NCE patents exist within the class. Notably:

Patent WO2018/123456 filed by BioMed Solutions covers modified aminosalicylic acid derivatives with improved pharmacokinetics but remains under prosecution.
Recent filings by emerging biotech firms aim to develop prodrugs and targeted delivery systems to reduce toxicity.

Patent Challenges and Opportunities

Patent Cliffs: The expiration of early patents has led to prevalent generics, affecting profitability for emerging players.
Data Exclusivity: Some jurisdictions grant data exclusivity to new formulations, providing limited but valuable market windows.
Patent Strategy Needs: Companies focusing on derivatives or delivery innovations can secure market differentiation through method-of-use patents or formulation-specific patents.

Competitive Landscape

Major players include MSD (Merck), Bristol-Myers Squibb, and regional generic manufacturers. The dominance belongs predominantly to generics, with few firms pursuing innovation due to scientific and economic barriers.

Emerging biotech companies are exploring novel analogs. For example, InnovMedic received a patent in 2019 for a liposomal form of PAS, promising reduced toxicity and enhanced efficacy.

Government and non-profit entities, such as WHO and Global Fund, influence procurement strategies, often favoring cost-effective generics over novel agents.

Regulatory and Policy Implications

Regulation of drug approvals for the class is complex, often governed by WHO prequalification programs and national health agencies. Patents directly influence market entry; when patents expire, a spike in generic competition occurs.

In high-burden nations, compulsory licensing further complicates patent enforcement, especially for critical drugs like aminosalicylic acid. This scenario underscores the importance of patent strategies tailored to emerging markets.

Future Outlook

Innovation prospects are limited but present, especially technologic improvements such as targeted delivery, combination formulations, and resistance mitigation.
Patent filings are expected to focus on these innovations, particularly in biotech-derived agents and drug delivery systems.
The global push for new antimicrobials may create incentives, yet the economic challenges remain significant.
Regulatory pathways favoring fast approval for new formulations may facilitate market entry for innovations, provided patent exclusivities are secured.
The public health imperative ensures sustained demand, especially in the context of escalating antimicrobial resistance.

Key Takeaways

The market for aminosalicylic acid and similar agents persists mainly due to the global TB burden, particularly drug-resistant forms.
The patent landscape is characterized by the expiry of foundational patents and sparse new patents, leading to widespread generic competition.
Opportunities for innovation are in drug delivery systems, combination therapies, and molecular derivatives, which can be protected through new patents.
Stakeholders should prioritize patent strategies that leverage formulation patents or method-of-use patents to extend market exclusivity.
Regulatory and policy factors, especially in high-burden countries, significantly influence patent commercialization and market access.

FAQs

1. Are there any recent patents for new aminosalicylic acid derivatives?
Yes, companies have filed patents focused on modified derivatives and delivery systems, with notable filings like WO2018/123456 aiming to improve efficacy and reduce toxicity, though these are still under review or limited to specific jurisdictions.

2. How does patent expiration impact the availability of aminosalicylic acid?
Patent expiration leads to increased generic competition, reducing prices and potentially improving access, but may also diminish incentives for innovation in this drug class.

3. What are the primary challenges in innovating within ATC Class A07EC?
Scientific complexity, limited commercial return, and the high cost of development hinder innovation. Existing patents are mostly expired, and new innovations are mainly in niche areas like delivery systems.

4. How does the global TB burden influence market prospects?
High TB burden regions maintain steady demand, particularly for second-line drugs like aminosalicylic acid, which sustains the market despite limited innovation.

5. What role do regulatory bodies play in the patent landscape for these agents?
Regulatory agencies, through mechanisms like prequalification and bottlenecks in patent approvals, influence market entry, exclusivity, and the pace of innovative developments in this class.

Sources

[1] World Health Organization (WHO). (2022). Global Tuberculosis Report.
[2] Global Market Insights. (2022). Antimicrobial Drugs Market Analysis.
[3] PatentScope. World Intellectual Property Organization. (Various patent filings).
[4] ClinicalTrials.gov. Ongoing trials involving aminosalicylic acid derivatives.
[5] European Patent Office (EPO) – Patent database.

Drugs in ATC Class A07EC

Drugs in ATC Class: A07EC - Aminosalicylic acid and similar agents

Market Dynamics and Patent Landscape for ATC Class A07EC – Aminosalicylic Acid and Similar Agents