AMOXICILLIN - Generic Drug Details

What are the generic sources for amoxicillin and what is the scope of freedom to operate?

Amoxicillin is the generic ingredient in twenty-five branded drugs marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Glaxosmithkline, Us Antibiotics, Apothecon, Parke Davis, Wyeth Ayerst, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, Ph Health, Pragma, Ranbaxy Labs Ltd, Ani Pharms, Rising, Takeda Pharms Usa, Cumberland, Phathom, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, Teva Pharms Usa, and Talicia Holdings, and is included in one hundred and twenty-six NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amoxicillin has eleven patent family members in six countries.

There are forty-six drug master file entries for amoxicillin. Thirty-eight suppliers are listed for this compound.

Summary for AMOXICILLIN

International Patents:	11
US Patents:	12
Tradenames:	25
Applicants:	34
NDAs:	126
Drug Master File Entries:	46
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	677
Patent Applications:	5,888
Drug Prices:	Drug price trends for AMOXICILLIN
Drug Sales Revenues:	Drug sales revenues for AMOXICILLIN
What excipients (inactive ingredients) are in AMOXICILLIN?	AMOXICILLIN excipients list
DailyMed Link:	AMOXICILLIN at DailyMed

See drug prices for AMOXICILLIN

See drug sales revenues for AMOXICILLIN

Recent Clinical Trials for AMOXICILLIN

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

Sponsor	Phase
Agnaldo Rocha de Souza Junior	NA
Fundao de Amparo Pesquisa do Estado de So Paulo	PHASE4
University of Sao Paulo General Hospital	PHASE4

See all AMOXICILLIN clinical trials

Pharmacology for AMOXICILLIN

Drug Class

Penicillin-class Antibacterial

Medical Subject Heading (MeSH) Categories for AMOXICILLIN

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for AMOXICILLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	LAROTID	amoxicillin	FOR SUSPENSION;ORAL	050460-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sandoz	AMOXICILLIN	amoxicillin	FOR SUSPENSION;ORAL	065387-002	Mar 26, 2007	AB	RX	No	No
Teva	AMOXICILLIN	amoxicillin	CAPSULE;ORAL	061926-003	Approved Prior to Jan 1, 1982	AB	RX	No	Yes
Apothecon	TRIMOX	amoxicillin	CAPSULE;ORAL	062152-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	AMOXIL	amoxicillin	CAPSULE;ORAL	050459-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065089-001	May 25, 2004	AB	RX	No	No
Aurobindo	AMOXICILLIN	amoxicillin	FOR SUSPENSION;ORAL	065334-002	Dec 28, 2006	AB	RX	No	No

Expired US Patents for AMOXICILLIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008
Pragma	MOXATAG	amoxicillin	TABLET, EXTENDED RELEASE;ORAL	050813-001	Jan 23, 2008

International Patents for AMOXICILLIN

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008069806
China	101563466
Japan	2010511607
Japan	5788142
Japan	2010511607
World Intellectual Property Organization (WIPO)	2007067770
Japan	5788142

Market Dynamics and Financial Trajectory for Amoxicillin: An In-Depth Analysis

Last updated: January 15, 2026

Executive Summary

Amoxicillin, a broad-spectrum penicillin antibiotic, remains a cornerstone in bacterial infection treatment globally. Despite facing challenges related to antimicrobial resistance and competition from newer antibiotics, its market sustains due to widespread clinical use, expanded indications, and its role as a key drug in generic formulations. This report examines the current market dynamics, growth drivers, competitive landscape, regulatory environment, and revenue projections for Amoxicillin from 2023 onward.

Key insights include:

• An estimated global market size exceeding $2 billion in 2022.
• Compound annual growth rate (CAGR) projection of approximately 2% through 2027.
• Challenges including antimicrobial resistance (AMR), patent expiration, and alternative therapies.
• Opportunities driven by expanding healthcare access in emerging markets and potential formulation innovations.

---

What Are the Current Market Dynamics for Amoxicillin?

Market Size and Revenue Overview

Parameter	2022 Estimate	Notes
Global Market Size	$2.1 billion	Based on IMS Health and MarketsandMarkets data [1][2]
CAGR (2023–2027)	~2%	Moderated by generic dominance and resistance trends
Regional Revenue Split	North America: 40%, Europe: 25%, Asia-Pacific: 20%, Rest of World: 15%	Geographic distribution reflects prescribing patterns and healthcare access

Key Market Drivers

• Widespread Clinical Use: Essential treatment for pneumonia, urinary tract infections (UTIs), and skin infections. Its simplicity and efficacy sustain demand.
• Generic Penetration: As a patent-expired drug, generic formulations dominate the market, keeping prices low and accessibility high.
• Expanding Healthcare Access: Increasing healthcare infrastructure, especially in Asia-Pacific and Africa, enhances prescribing volumes.
• Regulatory Approvals for New Indications: Ongoing studies suggest potential for repurposing or expanding indications, particularly in pediatric and respiratory infections.

Market Challenges and Constraints

Challenge	Impact & Details	References
Antimicrobial Resistance (AMR)	Rising resistance reduces efficacy, necessitating alternative therapies	[3][4]
Patent Expiry & Generics Growing Market	Reduced prices, margin pressures for manufacturers	[2]
Competition from Broader Spectrum or New Drugs	Doxycycline, azithromycin, newer cephalosporins	[5]
Stringent Regulatory Frameworks	Requiring continuous clinical data and safety monitoring	[6]

Impact of AMR on Market Trajectory

Antimicrobial resistance (AMR) increasingly constrains amoxicillin’s effectiveness, especially against Streptococcus pneumoniae and Escherichia coli. Studies indicate resistance rates have increased by 10-20% over the past decade in key regions (e.g., North America, Europe). This trend is expected to limit long-term growth without innovation or combination therapies.

How Has the Competitive Landscape Evolved?

Dominance of Generics

Company	Market Share	Key Products	Price Range	Notes
Teva Pharmaceuticals	35%	Amoxicillin Trihydrate Tablets	$0.05 – $0.10 per capsule	Leading generic manufacturer globally
Sandoz (Novartis)	20%	Amoxicillin formulations	Similar to Teva	Focus on biosimilars and generics
Mylan (now part of Viatris)	15%	Amoxicillin capsules	Competitive pricing	Wide distribution network
Other Players	30%	Various local and regional brands	Price varies	Fragmented market

Note: The high commoditization of amoxicillin reduces profitability for manufacturers but sustains widespread availability.

Emerging Innovations & Formulations

• Extended-release formulations
• Combining amoxicillin with clavulanic acid for beta-lactamase coverage
• Potential for inhalable or parenteral formulations under clinical evaluation

Regulatory Environment and Patent Landscape

• The original patent for amoxicillin expired by 2005 in major markets, facilitating generic entry.
• Regulatory agencies such as FDA, EMA, and PMDA enforce strict standards, although the off-patent status minimizes delays in market access for generics.

What Are the Financial Projections for Amoxicillin?

Revenue Forecasts (2023–2027)

Year	Estimated Market Size	Growth Rate	Key Assumptions
2023	$2.12 billion	1.9%	Continued generic availability, steady prescribing trends
2024	$2.17 billion	2.4%	Increasing access in emerging markets
2025	$2.22 billion	2.3%	Minor improvements from formulations and expanded indications
2026	$2.27 billion	2.2%	Slight resistance impacts partially offset by new markets
2027	$2.33 billion	2.0%	Market stabilization, potential impact of emerging resistance

Note: These projections factor in inflation, population growth, and expanding healthcare coverage, especially in Asia-Pacific and Africa.

Revenue Breakdown by Region (2022–2027 Projection)

Region	2022 Revenue	2027 Projection	CAGR	Rationale
North America	$840 million	$870 million	0.8%	Saturated market, slow growth due to resistance complexities
Europe	$530 million	$560 million	1.0%	Continued demand with moderate growth
Asia-Pacific	$420 million	$530 million	4.4%	Rapid expansion driven by growing healthcare infrastructure
Rest of World	$320 million	$360 million	3.2%	Infrastructure improvements and population growth

---

How Do Market Factors Differ Across Key Regions?

Region	Prescribing Trends	Resistance Trends	Regulatory & Reimbursement Dynamics	Market Entry Barriers
North America	Conservative, guideline-driven	Increasing, particularly in E. coli & S. pneumoniae	Tighter, insurance-driven reimbursement	High, due to strict FDA regulations
Europe	Similar to North America, with national variations	Moderate, ongoing AMR surveillance	Unified EMA standards with country-specific adjustments	Moderate
Asia-Pacific	Growing, especially in China & India	Higher, due to misuse and overuse	Emerging, improving regulatory frameworks	Lower, due to less strict enforcement
Africa & Latin America	Rapid growth potential	Less data; likely higher due to over-the-counter sales	Developing, often informal markets	Low, but quality concerns remain

---

What Is the Outlook for Future Innovations and Market Expansion?

Opportunities

• Formulation Innovations: Development of sustained-release or inhalable amoxicillin variants could enhance compliance, especially in pediatric populations.
• Combination Therapies: Pairs with beta-lactamase inhibitors or novel agents to combat resistance.
• Digital and Pharmacogenomic Approaches: Tailored therapies based on resistance profiles for personalized medicine.

Potential Risks

• Emergence of Resistance: Rapid evolution could diminish effectiveness.
• Regulatory Hurdles: New formulations or combinations may face lengthy approval processes.
• Market Saturation: Particularly in developed countries, limiting growth prospects.

Key Takeaways

• Despite a mature, highly generic market, Amoxicillin remains vital, with a forecasted steady growth trajectory driven by expanding healthcare access and emerging markets.
• Antimicrobial resistance and competition from newer antibiotics pose significant challenges, potentially capping long-term growth.
• Innovation, particularly in formulations, combination therapies, and personalized medicine, offers avenues to extend market relevance.
• Regional dynamics vary considerably, requiring tailored strategies for market entry and expansion.
• Continuous monitoring of resistance trends, regulatory policies, and technological advancements is essential for stakeholders aiming to capitalize on Amoxicillin's market.

---

FAQs

1. How does antimicrobial resistance impact the future profitability of Amoxicillin?
Rising resistance diminishes drug efficacy, compelling prescribers to switch to alternative antibiotics, thereby reducing Amoxicillin’s market share and potentially lowering revenue. Investment in combination therapies or formulations could mitigate this impact.

2. Are there any recent patent filings or exclusivity periods expected for Amoxicillin?
No; Amoxicillin’s original patents expired over a decade ago, resulting in widespread generic availability, which keeps prices low and limits monetization opportunities solely to manufacturing and distribution efficiencies.

3. Which regions are expected to see the fastest growth in Amoxicillin demand?
Emerging markets in Asia-Pacific and Africa are projected to experience the highest growth rates, driven by expanding healthcare infrastructure, increased infectious disease prevalence, and improving access.

4. What technological innovations could redefine Amoxicillin's market?
Formulation advancements such as extended-release options, inhalable forms, and fixed-dose combinations with other antibiotics are promising innovations that could prolong market relevance.

5. How do regulatory policies influence the manufacturing and distribution of Amoxicillin?
Stringent quality standards by agencies like the FDA and EMA necessitate rigorous manufacturing practices, but rapid approval of generics facilitates widespread availability. Regulatory harmonization and surveillance directly impact market stability and compliance costs.

---

References

[1] IMS Health, "Global Antibiotics Market Report," 2022.
[2] MarketsandMarkets, "Antibiotics Market," 2022.
[3] European Centre for Disease Prevention and Control (ECDC), "Antimicrobial Resistance Surveillance Report," 2021.
[4] World Health Organization (WHO), "Global Action Plan on Antimicrobial Resistance," 2015.
[5] CDC, "Antibiotic Resistance Threats in the United States," 2019.
[6] U.S. Food and Drug Administration (FDA), "Guidelines for Antibiotic Drug Approvals," 2022.