Drugs and patents in ATC class A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

Last updated: July 28, 2025

Introduction

The ATC Classification System designated A02B encompasses pharmaceuticals used in the treatment of peptic ulcers and gastro-oesophageal reflux disease (GORD). These conditions affect millions globally and generate significant pharmaceutical R&D investments due to their high prevalence, chronicity, and unmet medical needs. The evolving market landscape is influenced by technological innovations, patent expirations, regulatory changes, and rising demand for effective therapies. Analyzing this field's current patents offers insights into strategic positioning and future innovation trajectories.

Market Overview and Key Players

Global Market Size and Growth

The global market for drugs targeting peptic ulcers and GORD was valued at approximately USD 10 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of around 3-4% through 2030 [1]. The increase in lifestyle-related risk factors, including obesity and dietary habits, sustains demand. Moreover, aging populations in developed countries contribute to higher prevalence rates.

Therapeutic Landscape

Historically, proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids formed the core treatments:

Proton Pump Inhibitors (PPIs): Esomeprazole, omeprazole, pantoprazole, rabeprazole, and dexlansoprazole dominate the market with high efficacy in acid suppression [2].
H2 Receptor Antagonists: Ranitidine (withdrawn in some markets due to safety concerns), famotidine, nizatidine.
Alginates and Antacids: Often used as adjuncts.

Emerging Trends

Recent trends focus on:

Novel PPI formulations with improved pharmacokinetics and reduced side effects.
Potassium-competitive acid blockers (P-CABs): Such as vonoprazan, offering faster, sustained acid suppression.
Ghrelin receptor antagonists and biologics: Under investigation for refractory cases.
Personalized medicine approaches based on genetic and microbiome profiling.

Major Market Participants

Key pharmaceutical companies include:

AstraZeneca: Leading with Nexium (esomeprazole).
Takeda Pharmaceuticals: Produces Takeda's P-CAB vonoprazan.
Pfizer: Formerly a major player with Protonix.
Kalbe Farma: Focused regionally.
Innovator companies investing in biologic and targeted therapies.

Patent Landscape Analysis

Patent Filing Trends

Patent filings for A02B drugs have experienced fluctuations reflecting innovation cycles, patent expirations, and strategic patenting. Notably:

Peak activity: occurred between 2000 and 2015, driven by generic entries and first-generation PPI disclosures [3].
Recent filings: focus on extended-release formulations, combination therapies, and P-CABs, especially vonoprazan.

Patent Expirations and Implications

Major patents on first-generation PPIs, including omeprazole and esomeprazole, expired around 2015 and 2018, respectively, opening markets to generics. This has prompted innovation in:

Formulation patents: sustained exclusivity through delayed biosimilar entry.
Method-of-use patents: protecting combination therapeutics or novel dosing regimens.
Innovative compounds: P-CABs, such as vonoprazan, have fewer patent expirations and are expanding market share.

Notable Patent Filings

Recent patent applications are exploring:

Next-generation PPIs with improved stability and faster onset.
Combination therapies targeting Helicobacter pylori eradication to reduce ulcer recurrence.
Biologics and peptides targeting underlying pathophysiology.

Relevant patents include those filed by Takeda on vonoprazan derivatives and formulations, as well as Pfizer’s innovations in PPI delivery systems [4].

Patent Challenges and Litigation

Major patent litigations involve brand-name pharmaceutical companies defending their core formulations against attempts by generics to challenge validity. The Hatch-Waxman framework has facilitated patent term extensions but also heightened patent challenge activity.

Regulatory Environment and Market Impact

Regulatory agencies such as FDA and EMA prioritize safety and efficacy, prompting post-marketing surveillance, especially for long-term use of PPIs linked to adverse effects. Patent protections can influence the timing of market entry for generics and biosimilars.

Innovative drugs, especially P-CABs, typically undergo rigorous clinical trials and gain market exclusivity. While patents offer protection, some strategies—like patent thickets and secondary patents—are employed to extend market monopoly.

Future Outlook and Innovation Opportunities

The future of A02B drugs lies in:

Addressing unmet needs in refractory or complicated GORD cases.
Developing safer, more effective long-term therapies with reduced side effects.
Harnessing personalized medicine for tailored treatment strategies.
Exploring biologic and peptide-based therapeutics as alternatives to small molecules.

Patent activity suggests robust pipeline innovation, with companies securing broad claims in novel compound classes and advanced formulations. The landscape indicates increasing diversification beyond traditional PPIs into biologics and combination therapies.

Key Challenges

Patent expiries leading to generic competition.
Safety concerns with long-term PPI use, influencing regulatory and market dynamics.
Competition from emerging drug classes like P-CABs.
Patent litigation and difficulty in securing broad patent claims.

Strategic Considerations for Stakeholders

Innovator companies must focus on extending patent life via formulations, combinations, and new derivatives.
Generics and biosimilars are poised for growth post-patent expiry, emphasizing the importance of patent challenge strategies.
Investors should monitor patent filings related to P-CABs and biologics for emerging opportunities.

Conclusion

The pharmacological landscape for peptic ulcer and GORD drugs within ATC Class A02B is dynamic, driven by innovation, patent strategies, and regulatory landscapes. While first-generation PPIs dominate, the surge in P-CAB research and biologic therapeutics signals a transformative period. Effective patent management remains critical for market exclusivity, with ongoing innovations promising to improve clinical outcomes and address unmet needs.

Key Takeaways

The A02B market is mature but continues to evolve with innovation in P-CABs and biologics.
Patent expiries have opened markets for generics; however, strategic patenting sustains exclusivity for novel formulations and derivatives.
Investment in personalized therapies and safer drugs is game-changing for future development.
Patent filings indicate a focus on next-generation acid suppressants with improved safety profiles.
Regulatory and patent challenges shape the competitive landscape, emphasizing the importance of robust patent strategies.

FAQs

Q1: How have patent expirations affected the market for traditional PPIs?

A: Patent expirations on first-generation PPIs like omeprazole have led to a surge in generic options, increasing affordability and market penetration but diminishing revenue streams for original patent holders. This has incentivized innovator companies to develop next-generation drugs with extended patents or improved efficacy.

Q2: What role do P-CABs play in the future landscape of A02B drugs?

A: Potassium-competitive acid blockers (P-CABs), such as vonoprazan, offer faster, more sustained acid suppression than PPIs. They are currently under patent protection and are gaining market share, representing a significant innovation trajectory with potential to disrupt traditional therapy paradigms.

Q3: Are biologics a significant part of the patent landscape for A02B drugs?

A: While biologics are still emerging in this therapeutic area, ongoing research into peptide-based and biologic agents targeting underlying mechanisms offers promising patent filings. However, most current patents focus on small-molecule compounds and formulations.

Q4: How do patent strategies influence the development of combination therapies in this field?

A: Companies pursue patents on specific combinations, dosing methods, and formulations to extend exclusivity and protect against competitors. These patents can delay generic competition and foster innovation in multi-target treatments.

Q5: What challenges do innovators face in securing broad patent protection for new drugs in this class?

A: Challenges include patentability hurdles due to prior art, risk of patent invalidation, patent thickets making effective exclusion difficult, and regulatory scrutiny. Companies must craft comprehensive claims and navigate complex legal landscapes to maintain competitive advantage.

References

[1] MarketWatch, “Gastrointestinal Drugs Market Size and Trends,” 2022.

[2] Grand View Research, “Proton Pump Inhibitors Market Analysis,” 2021.

[3] WHO Patent Database, “Patent Filing Trends in Gastrointestinal Pharmacology,” 2010–2022.

[4] Patent Landscape Reports, Various, 2022.

Drugs in ATC Class A02B

Subclasses in ATC: A02B - DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

Market Dynamics and Patent Landscape for ATC Class A02B — Drugs for Peptic Ulcer and Gastro-Oesophageal Reflux Disease (GORD)