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Last Updated: December 11, 2025

Amoxicillin; clarithromycin; lansoprazole - Generic Drug Details


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What are the generic sources for amoxicillin; clarithromycin; lansoprazole and what is the scope of patent protection?

Amoxicillin; clarithromycin; lansoprazole is the generic ingredient in two branded drugs marketed by Ani Pharms, Rising, Sandoz, and Takeda Pharms Usa, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for amoxicillin; clarithromycin; lansoprazole
Recent Clinical Trials for amoxicillin; clarithromycin; lansoprazole

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

SponsorPhase
National Taiwan University HospitalPHASE2
Nanjing First Hospital, Nanjing Medical UniversityEARLY_PHASE1
Fu Jen Catholic University HospitalPhase 4

See all amoxicillin; clarithromycin; lansoprazole clinical trials

US Patents and Regulatory Information for amoxicillin; clarithromycin; lansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 200218-001 Aug 30, 2013 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sandoz LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 202588-001 Mar 4, 2014 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Rising LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 206006-001 Oct 7, 2016 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for amoxicillin; clarithromycin; lansoprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 4,628,098*PED ⤷  Get Started Free
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 5,093,132*PED ⤷  Get Started Free
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 5,433,959*PED ⤷  Get Started Free
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 5,045,321*PED ⤷  Get Started Free
Takeda Pharms Usa PREVPAC (COPACKAGED) amoxicillin; clarithromycin; lansoprazole CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL 050757-001 Dec 2, 1997 5,013,743*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Amoxicillin, Clarithromycin, and Lansoprazole

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape surrounding amoxicillin, clarithromycin, and lansoprazole remains critical due to their widespread clinical use and significant market presence. These drugs, prescribed primarily for bacterial infections and acid-related disorders, have experienced evolving demand driven by factors such as bacterial resistance patterns, regulatory shifts, and treatment guidelines. This comprehensive analysis explores the current market dynamics and forecasts the financial trajectory for these medications, offering insights for industry stakeholders, investors, and healthcare policymakers.

Market Overview

Amoxicillin

Amoxicillin, a broad-spectrum penicillin antibiotic, remains a frontline agent for various bacterial infections, including respiratory tract infections, urinary tract infections, and skin infections. Its long-standing safety profile and generic availability have cemented its market dominance. The global amoxicillin market was valued at approximately USD 1.1 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 3% through 2030 [1].

Clarithromycin

Clarithromycin, a macrolide antibiotic, is primarily utilized for Helicobacter pylori eradication, respiratory infections, and skin conditions. The market faced disruptions owing to patent expirations, increased generic competition, and concerns related to antimicrobial resistance. The global clarithromycin market was valued at around USD 500 million in 2022 and is expected to grow modestly, with a CAGR of approximately 2% over the next decade [2].

Lansoprazole

Lansoprazole, a proton pump inhibitor (PPI), is extensively prescribed for gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. Its patent expiration in many regions has facilitated a surge in generic options, culminating in a competitive landscape with a declining price trend. The market value stood at near USD 2 billion in 2022, with projections for a slow CAGR of 1.5% until 2030 [3].

Market Drivers

Antimicrobial Resistance and Prescribing Trends

Rising antimicrobial resistance (AMR) has prompted revisions in prescribing guidelines, especially for clarithromycin. The World Health Organization (WHO) classifies certain strains as resistant, compelling clinicians to consider alternative therapies [4]. Conversely, the decreasing resistance rates in some regions bolster the sustained utility of amoxicillin and clarithromycin as first-line agents.

Generic Competition and Pricing Pressures

The expiration of patents and the entry of generic manufacturers for all three drugs have intensified price competition, leading to reduced drug prices and margins. For instance, amoxicillin’s generic availability has driven prices down by over 30% in North America over the past five years [5].

Regulatory Shifts and Approval Dynamics

Regulatory agencies have increased scrutiny concerning antimicrobial stewardship, which influences prescribing practices and market access. Additionally, new formulations or combination therapies (e.g., amoxicillin with clavulanic acid) can alter market dynamics by shifting demand.

Healthcare Access and Disease Burden

The prevalence of bacterial infections and acid-related disorders continues to sustain demand. The global burden of Helicobacter pylori infection affects clarithromycin’s use, especially in developing countries. Meanwhile, the rising incidence of GERD supports PPI market stability, albeit with increasing substitution by newer medications.

Innovation and Formulation Developments

Limited innovation with these established drugs results in minimal new patent protections. However, sustained research into combination therapies and novel delivery mechanisms could influence future growth patterns.

Financial Trajectory Analysis

Revenue Forecasts and Market Trends

The combined revenue of these drugs is poised to exhibit modest but steady growth through 2030, driven by global healthcare needs. Major markets like North America and Europe will continue to dominate, although emerging markets in Asia-Pacific and Latin America are expected to see faster growth owing to increasing healthcare access and infectious disease burden.

Pricing and Revenue Margins

Intense generic competition is expected to exert ongoing downward pressure on unit prices. However, larger volumes and increased prescribing in developing regions can offset margin compression. For example, countries with high H. pylori prevalence are likely to sustain clarithromycin sales despite generics’ entry.

Impact of Resistance and Stewardship Initiatives

Growth trajectories may be influenced by antimicrobial stewardship efforts aimed at curbing misuse. Restrictions or guidelines limiting use can temporarily suppress sales, but longer-term, these may promote the development of more targeted antibiotics, reshaping the market landscape.

Emerging Opportunities

Combination therapies, such as amoxicillin-clavulanate and PPI-based regimens, can provide new revenue streams. Additionally, proprietary formulations, extended-release options, and adjunctive therapies could extend market exclusivity and R&D investment returns.

Market Risks and Challenges

Key risks include escalating antimicrobial resistance, regulatory restrictions, and pricing controls in several jurisdictions. Furthermore, the advent of novel treatments, such as microbiome-based therapies, could challenge the long-term dominance of traditional antibiotics.

Regulatory and Competitive Landscape

Major pharmaceutical firms (e.g., GlaxoSmithKline, AstraZeneca, and Teva) dominate manufacturing, leveraging extensive production networks and market penetration. Regulatory agencies—from the FDA to the EMA—continue to impose standards that may delay approval or restrict certain formulations.

The entry of biosimilars or generic equivalents has reshaped competitive dynamics, often eroding profitability. Patent cliffs for key formulations precipitate short-term revenue declines but offer opportunities for generics manufacturers to increase market share.

Strategic Considerations for Industry Stakeholders

  • Invest in R&D: Focus on innovative formulations and combination therapies to extend market exclusivity.
  • Monitor Resistance Trends: Adjust prescribing practices and develop new antibiotics to address resistance patterns.
  • Expand in Emerging Markets: Address unmet needs and leverage increasing healthcare infrastructure.
  • Optimize Pricing Strategies: Balance affordability with margin preservation amid competitive pressures.
  • Engage in Stewardship and Regulation: Collaborate with policymakers to develop sustainable antimicrobial use policies.

Conclusion

The market for amoxicillin, clarithromycin, and lansoprazole exhibits resilience characterized by steady but moderated growth amid a landscape of increasing generic competition, regulatory oversight, and antimicrobial resistance concerns. While the overall financial trajectory indicates modest expansion opportunities, strategic innovation and market diversification remain essential for stakeholders aiming to optimize returns and support sustainable healthcare delivery.


Key Takeaways

  • The combined market value of amoxicillin, clarithromycin, and lansoprazole is projected to grow modestly through 2030, mainly driven by emerging economies and increasing disease prevalence.
  • Generic competition and pricing pressures pose significant challenges, although new formulations and combination therapies present growth avenues.
  • Antimicrobial resistance and stewardship initiatives will influence prescribing trends and market dynamics, necessitating continuous innovation.
  • Developing regions offer substantial growth opportunities due to rising healthcare access and infectious disease burden.
  • Strategic investments in research, regulatory engagement, and market expansion are crucial to harvesting the full potential of these established drugs.

FAQs

  1. What factors most significantly impact the market sales of amoxicillin, clarithromycin, and lansoprazole?
    Antimicrobial resistance patterns, generic drug competition, healthcare access, and prescribing guidelines primarily influence market sales. Regulatory policies and emerging treatment alternatives also play roles.

  2. How does antimicrobial resistance affect the future of these drugs?
    Increasing resistance can diminish effectiveness, leading to reduced prescriptions and prompting the need for new antibiotics or combination therapies. Stewardship efforts aim to balance use and preserve efficacy.

  3. Are there new formulations or combinations planned for these drugs?
    While limited innovation exists currently, efforts are underway to develop combination therapies (e.g., clarithromycin with other agents) and extended-release formulations, aimed at improving compliance and efficacy.

  4. What is the impact of patent expirations on market revenues?
    Patent expirations facilitate generic entry, lowering prices and margins but also expanding access and volume, which can offset revenue decline through increased overall sales, especially in emerging markets.

  5. Which regions offer the most significant growth opportunities for these drugs?
    Asia-Pacific, Latin America, and parts of Africa present considerable opportunities due to expanding healthcare infrastructure, high disease burden, and unmet medical needs.


References

  1. [1] MarketWatch, "Global Amoxicillin Market Size, Share & Trends Analysis," 2022.
  2. [2] Grand View Research, "Clarithromycin Market Analysis," 2022.
  3. [3] MarketsandMarkets, "Proton Pump Inhibitors Market Forecast," 2022.
  4. [4] WHO Report on Antimicrobial Resistance, 2021.
  5. [5] IQVIA, "Global Trends in Antibiotic Pricing," 2022.

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