AMOXICILLIN; CLAVULANATE POTASSIUM - Generic Drug Details

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

Amoxicillin; clavulanate potassium is the generic ingredient in nine branded drugs marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Us Antibiotics, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-seven suppliers are listed for this compound.

Summary for AMOXICILLIN; CLAVULANATE POTASSIUM

US Patents:	0
Tradenames:	9
Applicants:	15
NDAs:	49
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	19
DailyMed Link:	AMOXICILLIN; CLAVULANATE POTASSIUM at DailyMed

Recent Clinical Trials for AMOXICILLIN; CLAVULANATE POTASSIUM

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

Sponsor	Phase
Cairo University	PHASE3
Second Affiliated Hospital of Wenzhou Medical University	N/A
Alphacait, LLC	Phase 2

See all AMOXICILLIN; CLAVULANATE POTASSIUM clinical trials

Pharmacology for AMOXICILLIN; CLAVULANATE POTASSIUM

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN; CLAVULANATE POTASSIUM

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

Paragraph IV (Patent) Challenges for AMOXICILLIN; CLAVULANATE POTASSIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUGMENTIN XR	Extended-release Tablets	amoxicillin; clavulanate potassium	1000 mg/62.5 mg	050785	1	2009-01-21

US Patents and Regulatory Information for AMOXICILLIN; CLAVULANATE POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deva Holding As	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	209992-001	Sep 15, 2023	AB	RX	No	No
Cipla	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065431-001	Nov 25, 2008	AB	RX	No	No
Sun Pharm Inds Ltd	AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	065132-002	Mar 19, 2003		DISCN	No	No

Expired US Patents for AMOXICILLIN; CLAVULANATE POTASSIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	6,746,692
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	7,217,430
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002	7,250,176

Market Dynamics and Financial Trajectory for Amoxicillin-Clavulanate Potassium

Last updated: July 29, 2025

Introduction

Amoxicillin-Clavulanate Potassium, commonly known as Augmentin, is a widely prescribed broad-spectrum antibiotic combination used to treat various bacterial infections. Its unique pharmacological synergy—amoxicillin’s bactericidal activity coupled with clavulanate’s beta-lactamase inhibition—enables effective treatment against resistant strains, positioning it as a crucial antimicrobial agent globally (1). This analysis explores current market dynamics and future financial trajectories, considering evolving healthcare trends, regulatory factors, competitive landscape, and innovation trajectories.

Market Overview

Global Market Size and Growth Projections

The global antibiotic market, valued at approximately USD 52 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 3.5% through 2030¹. Amoxicillin-clavulanate constitutes a significant share within the penicillin segment, reflecting its extensive clinical usage. Market analysts anticipate that increasing incidences of respiratory, urinary tract, and skin infections will sustain demand, especially in emerging economies where antibiotic access expands steadily.

Key Regional Markets

• North America: Dominates due to high prescription volumes, advanced healthcare infrastructure, and regulatory approvals. The U.S. leads, with an estimated 20% of the global antibiotics market, influenced by a high prevalence of bacterial infections and antibiotic stewardship programs (2).

• Europe: Exhibits substantial uptake, driven by stringent antimicrobial stewardship and robust healthcare policies. However, recent efforts aim to curb antibiotic overuse, impacting growth trajectories.

• Asia-Pacific: Represents the fastest-growing segment, projected to surpass USD 15 billion by 2030. Factors include expanding healthcare access, rising income levels, and increasing prevalence of infectious diseases (3).

• Latin America & Middle East & Africa: Show stable growth, leveraging rising urbanization and improved healthcare infrastructure, yet face regulatory challenges and self-medication practices that affect market stability.

Competitive Landscape

Leading pharmaceutical firms such as GlaxoSmithKline, Mylan, and Teva dominate the amoxicillin-clavulanate market. These companies benefit from established manufacturing capacity, deep distribution channels, and brand recognition. Biosimilar and generic entrants continue to intensify competition, exerting downward pressure on prices and margins.

Market Drivers

Rising Antibiotic Resistance

The escalation of beta-lactamase–producing bacterial strains compels physicians to utilize combination antibiotics like amoxicillin-clavulanate. According to WHO, antimicrobial resistance (AMR) could cause 10 million deaths annually by 2050 if unaddressed, increasing reliance on effective combinations (4). Ongoing resistance development sustains demand but also pressures pharmaceutical companies to innovate.

Expanding Clinical Indications

Amoxicillin-clavulanate's efficacy against a broad spectrum of infections—including sinusitis, pneumonia, urinary tract infections, and skin infections—augments its market size. Additionally, its use in pediatric and adult populations enhances sales volume.

Regulatory Environment and Approvals

Stringent regulatory agencies, including FDA and EMA, continuously update guidelines on antibiotic use, influencing prescription patterns. While approval of extended-release formulations and combination variants can bolster sales, regulatory hurdles may delay market access for new formulations.

Public and Private Sector Initiatives

Global health programs aim to improve access to essential medicines. Initiatives like UNICEF’s procurement of antibiotics and government-led distribution campaigns in developing countries expand market reach.

Market Challenges

Antimicrobial Stewardship and Overuse

Adoption of antimicrobial stewardship programs aims to suppress over-prescription, potentially dampening growth in certain regions. Moreover, the global push to avoid unnecessary antibiotic use fosters a cautious prescribing environment.

Generic Competition and Pricing Pressures

The proliferation of generics reduces prices significantly, especially in price-sensitive markets such as India and China. This dispels profit margins for branded formulations and compels innovation-driven differentiation.

Resistance and Efficacy Concerns

Emerging resistance limits the treatment efficacy, prompting the need for higher doses or alternative therapies, which can impact the sales trajectory. Continuous resistance development requires ongoing research and formulation adjustments.

Patent Expirations and Biosimilars

While some formulations are off-patent, new combination versions or extended indications may be patent-protected, influencing market exclusivity. The entry of biosimilars and generics compresses revenue potential for branded drugs.

Financial Trajectory Analysis

Revenue Growth Prospects

Based on current trends, the global amoxicillin-clavulanate market is expected to sustain an annual growth rate of approximately 3–4% over the next decade. In emerging markets, growth could surpass this average due to increased healthcare access and disease prevalence.

Profitability and Pricing Dynamics

Branded formulations historically command higher margins, but price erosion caused by generic competition is intensifying. Innovator companies are increasingly investing in novel formulations, fixed-dose combinations, and extended-release variants to maintain profitability.

R&D and Innovation Investment

Investment in research aims to develop next-generation beta-lactam antibiotics with improved resistance profiles. The pipeline includes novel beta-lactam/beta-lactamase inhibitor combinations and alternative delivery systems to sustain long-term revenue streams.

Impact of Regulatory and Policy Changes

Policy shifts toward stricter antibiotic stewardship and regulatory approvals profoundly influence the market. Companies that efficiently navigate these frameworks can better capitalize on emerging opportunities.

Future Outlook and Strategic Opportunities

• Development of Novel Combinations: Formulations with enhanced efficacy against resistant strains can secure a competitive advantage.

• Expansion in Developing Markets: Growing healthcare infrastructure and disease burden in Asia-Pacific and Africa present significant opportunities.

• Digital and Precision Medicine Integration: Personalized treatment approaches and digital health tools could optimize antibiotic use, aligning profitability with sustainability.

• Addressing Resistance: Pioneering research into resistant pathogen-targeted therapies is essential to sustain market relevance.

• Regulatory Engagements: Proactive collaboration with governing bodies can expedite approval processes and ensure market access.

Conclusion

The market for amoxicillin-clavulanate potassium remains robust, driven by global infectious disease prevalence and resistance trends. However, it faces challenges from regulatory reforms, generic competition, and resistance emergence. Strategic innovation, geographic expansion, and adherence to stewardship policies will define its financial trajectory. Companies that adapt to these dynamics—embracing novel formulations, exploring emerging markets, and investing in R&D—are positioned to sustain growth and profitability.

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Key Takeaways

• The global amoxicillin-clavulanate market is projected to grow at approximately 3–4% CAGR through 2030, propelled by rising infectious disease burdens and resistance.

• Emerging markets, notably Asia-Pacific, present significant growth opportunities driven by expanding healthcare infrastructure and increasing antibiotic access.

• Price competition from generics and biosimilars exerts downward pressure, emphasizing the importance of innovation in formulation and delivery.

• Antimicrobial resistance remains both a driver for continued demand and a challenge threatening long-term efficacy.

• Strategic investments in R&D, regulatory engagement, and market diversification are critical for sustained profitability.

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FAQs

1. How does antimicrobial resistance impact the market for amoxicillin-clavulanate?
Resistance reduces the effectiveness of standard formulations, prompting the need for higher doses or alternative therapies. While demand remains high, resistance development pressures companies to innovate and develop new combinations or formulations.

2. What role do regulatory agencies play in shaping the market?
Agencies such as the FDA and EMA influence market dynamics through approval processes, guidelines on antibiotic use, and policies on stewardship. Synchronizing product development with regulatory standards is crucial for market access.

3. How do generic competitors affect the profitability of amoxicillin-clavulanate?
The presence of generic versions significantly reduces prices and margins for branded products. Companies must differentiate through formulations, delivery mechanisms, and indications to sustain profitability.

4. Which regions offer the most growth potential for amoxicillin-clavulanate?
Emerging economies in Asia-Pacific and Africa exhibit the highest growth potential owing to expanding healthcare access, rising infection rates, and government initiatives, despite regulatory and infrastructural challenges.

5. What innovations could extend the market life of amoxicillin-clavulanate?
Development of novel beta-lactamase inhibitors, fixed-dose combination therapies, extended-release formulations, and targeted delivery systems can help overcome resistance issues and differentiate products.

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Sources

[1] MarketsandMarkets, "Antibiotics Market by Product," 2022.

[2] IQVIA, "United States Prescription Antibiotics Market," 2022.

[3] Grand View Research, "Asia-Pacific Antibiotics Market," 2022.

[4] WHO, "Antimicrobial Resistance Global Report," 2022.