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Last Updated: December 16, 2025

AMOXICILLIN PEDIATRIC Drug Patent Profile


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When do Amoxicillin Pediatric patents expire, and what generic alternatives are available?

Amoxicillin Pediatric is a drug marketed by Teva and is included in one NDA.

The generic ingredient in AMOXICILLIN PEDIATRIC is amoxicillin. There are forty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Amoxicillin Pediatric

A generic version of AMOXICILLIN PEDIATRIC was approved as amoxicillin by TEVA on December 22nd, 1992.

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Summary for AMOXICILLIN PEDIATRIC
Drug patent expirations by year for AMOXICILLIN PEDIATRIC
Recent Clinical Trials for AMOXICILLIN PEDIATRIC

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SponsorPhase
Assistance Publique - Hpitaux de ParisPHASE4
University College, LondonPHASE2
Samsung Medical CenterPHASE4

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Pharmacology for AMOXICILLIN PEDIATRIC

US Patents and Regulatory Information for AMOXICILLIN PEDIATRIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva AMOXICILLIN PEDIATRIC amoxicillin FOR SUSPENSION;ORAL 061931-003 Dec 1, 1982 AB RX No 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

Last updated: August 5, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Amoxicillin Pediatric


Introduction

Amoxicillin Pediatric, a widely prescribed antibiotic in pediatric medicine, remains a cornerstone in treating common bacterial infections such as otitis media, pneumonia, and throat infections. With its proven efficacy, safety profile, and affordability, Amoxicillin Pediatric continues to dominate the pediatric antibiotic market. This article examines the current market dynamics and financial trajectory of Amoxicillin Pediatric, emphasizing factors shaping its future growth, competitive landscape, and investment considerations.


Market Overview

Amoxicillin Pediatric belongs to the penicillin class of antibiotics, approved for pediatric use for decades [1]. Its widespread utilization has resulted in a well-established market with consistent demand from healthcare providers worldwide. Despite the advent of novel antibiotics, Amoxicillin maintains a dominant position due to its clinical reliability and cost-effectiveness.

The global pediatric antibiotics market, valued at approximately USD 4 billion in 2022 [2], is projected to grow at a compound annual growth rate (CAGR) of around 3-4% through the next five years, driven by increasing pediatric populations, rising antibiotic resistance awareness, and expanding healthcare access in emerging markets.


Market Drivers

1. Rising Pediatric Population and Infection Incidence
Increasing birth rates and awareness of early childhood infections contribute directly to the consistent demand for pediatric antibiotics. According to UN data, the global pediatric population (ages 0-14) is projected to reach over 2 billion by 2030, providing a vast potential customer base [3].

2. Growing Awareness of Antibiotic Treatments
Enhanced diagnostic capabilities and physician awareness campaigns have led to more targeted antibiotic prescriptions, solidifying Amoxicillin Pediatric as the first-line treatment for various bacterial infections in children [4].

3. Cost-Effectiveness and Accessibility
Amoxicillin's affordability significantly influences prescribing patterns, especially in low- and middle-income countries (LMICs) where healthcare budgets are constrained. The availability of generic formulations further amplifies this trend [5].

4. Rising Antibiotic Resistance and Stewardship Initiatives
Antimicrobial stewardship efforts aim to optimize antibiotic use, encouraging appropriate prescriptions of first-line agents like Amoxicillin. These initiatives uphold Amoxicillin's relevance within treatment guidelines, thereby stabilizing demand [6].


Market Challenges and Competitive Factors

1. Antibiotic Resistance
The emergence of resistant strains reducing Amoxicillin's effectiveness poses a threat to its longevity. Beta-lactamase-producing bacteria compromise Amoxicillin’s efficacy, prompting the need for combination therapies or alternative drugs [7].

2. Market Saturation and Patent Expiry
Most Amoxicillin Pediatric formulations are off-patent, leading to intense generic competition. Market saturation limits potential price increases, exerting downward pressure on revenues [8].

3. Regulatory and Policy Changes
Stringent regulations promoting antimicrobial stewardship may restrict prescribing or influence formulation standards, potentially affecting market volume.

4. Alternative Therapies
The advent of new antibiotics or vaccination strategies reduces bacterial infection incidences, indirectly impacting Amoxicillin Pediatric demand.


Financial Trajectory and Revenue Outlook

Historical Performance:
Amoxicillin Pediatric has historically generated stable revenues, with global sales estimated at USD 1.5–2 billion annually [2]. Its market share remains significant, especially in regions with limited healthcare expenditure.

Future Revenue Projections:
Considering current trends, the market is expected to grow modestly. The key factors include:

  • Increased Antibiotic Resistance: Necessitates combination therapies or alternative medications, potentially limiting growth.
  • Generic Competition: Sustains low prices, capping revenue expansion.
  • Geographic Expansion: Developing countries' expanding healthcare infrastructure and pediatric populations could boost sales. Strategic emphasis on LMICs could add USD 300-500 million annually over the next five years.

Impact of Formulation Innovation:
Innovations such as chewable tablets, dispersible formulations, and improved dosing regimens might command premium pricing, slightly enhancing margins.

Price Trends:
In developed markets, pricing pressures due to healthcare reforms and generic competition persist. However, in emerging markets, price sensitivity remains high, supporting volume-based growth rather than price hikes.


Market Players and Competitive Landscape

Leading generic manufacturers such as Teva, Mylan (Viatris), Sandoz, and local pharmaceutical companies dominate the space. Brand-name formulations like Amoxil (GlaxoSmithKline) maintain a niche but face declining market share due to patent expiries and generics.

Market consolidation, partnerships with distribution networks, and regional manufacturing capacities are pivotal strategies undertaken by key players to enhance market penetration and cost efficiencies.


Regulatory and Global Health Considerations

The World Health Organization (WHO) designates Amoxicillin as a core antibiotic priority, underscoring its role in combating antimicrobial resistance. Efforts toward quality assurance, patent management, and adherence to international standards influence market accessibility and profitability [9].


Opportunities and Future Trends

  • Innovative Formulations: Development of age-appropriate, palatable formulations could improve adherence and command higher prices.
  • Combination Therapies: Fixed-dose combinations with clavulanic acid can mitigate resistance issues and widen market applications.
  • Digital Health Integration: Leveraging telemedicine and electronic prescribing could increase utilization rates.

Key Takeaways

  • The Amoxicillin Pediatric market remains stable with predictable growth, driven primarily by pediatric population trends and healthcare access expansion.
  • Challenges such as antibiotic resistance, generic competition, and regulatory measures temper rapid revenue growth.
  • Emerging markets represent significant growth opportunities, provided manufacturers adapt formulations and distribution strategies.
  • Innovation in formulations and combination therapies can sustain market relevance and improve financial performance.
  • Strategic investments in research, regional manufacturing, and stewardship compliance are vital for long-term profitability.

FAQs

1. How does antibiotic resistance impact the Amoxicillin Pediatric market?
Resistance diminishes Amoxicillin's efficacy, prompting shifts toward combination therapies or alternative antibiotics, which may decrease demand and revenue over time.

2. Are there ongoing developments in Amoxicillin formulations for children?
Yes, manufacturers are exploring flavors, dispersible tablets, and liquid formulations to improve adherence, potentially enabling premium pricing.

3. What is the outlook for Amoxicillin Pediatric in emerging markets?
Growth potential is high, as increasing pediatric populations and expanding healthcare infrastructure lead to higher demand.

4. How do patent expiries influence Amoxicillin's market dynamics?
Patent expiries lead to a surge in generic competition, exerting downward pressure on prices and margins.

5. What role do global health initiatives play in the Amoxicillin Pediatric market?
Organizations like WHO promote access and quality standards, influencing market regulation and encouraging responsible antibiotic use, which impacts supply and demand.


References

[1] WHO. (2019). "Antimicrobial resistance: global report on surveillance."
[2] MarketWatch. (2022). "Global Pediatric Antibiotics Market Size & Trends."
[3] United Nations. (2021). "World Population Prospects."
[4] CDC. (2020). "Antibiotic Use in Children."
[5] IMS Health. (2021). "Generic drug market trends."
[6] CDC Antibiotic Stewardship Program. (2022). "Best Practices."
[7] Bush, K., Jacoby, G. A. (2010). "Updated functional classification of β-lactamases." Clinical Microbiology Reviews.
[8] IMS Institute. (2022). "Generic pharmaceuticals overview."
[9] WHO. (2021). "Global priority list of antibiotic-resistant bacteria and resistance."

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