AUGMENTIN XR Drug Patent Profile

Which patents cover Augmentin Xr, and when can generic versions of Augmentin Xr launch?

Augmentin Xr is a drug marketed by Us Antibiotics and is included in one NDA.

The generic ingredient in AUGMENTIN XR is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Augmentin Xr

A generic version of AUGMENTIN XR was approved as amoxicillin; clavulanate potassium by SANDOZ on March 14^th, 2002.

Summary for AUGMENTIN XR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	76
Drug Prices:	Drug price information for AUGMENTIN XR
DailyMed Link:	AUGMENTIN XR at DailyMed

See drug prices for AUGMENTIN XR

Recent Clinical Trials for AUGMENTIN XR

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

Sponsor	Phase
Patient-Centered Outcomes Research Institute	Phase 4
Daniel Merenstein	Phase 4
University of California, Los Angeles	Phase 4

See all AUGMENTIN XR clinical trials

Paragraph IV (Patent) Challenges for AUGMENTIN XR

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 AUGMENTIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002		DISCN	Yes	No

Expired US Patents for AUGMENTIN XR

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
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002
Us Antibiotics	AUGMENTIN XR	amoxicillin; clavulanate potassium	TABLET, EXTENDED RELEASE;ORAL	050785-001	Sep 25, 2002

International Patents for AUGMENTIN XR

See the table below for patents covering AUGMENTIN XR around the world.

Country	Patent Number	Title	Estimated Expiration
Morocco	25352
Germany	10017883
Portugal	102450	FORMULACAO FARMACEUTICA DE LIBERTACAO MODIFICADA COMPREENDENDO AMOXICILINA E CLAVULANATO DE POTASSIO E UTILIZACAO DESTES COMPOSTOS NO FABRICO DE UM MEDICAMENTO PARA O TRATAMENTO DE INFECCOES BACTERIANAS
World Intellectual Property Organization (WIPO)	0061115
United Kingdom	0008923

Market Dynamics and Financial Trajectory for AUGMENTIN XR

Last updated: July 31, 2025

Introduction

AUGMENTIN XR, a sustained-release formulation combining amoxicillin and clavulanate potassium, has established itself as a cornerstone antibiotic in the management of complicated bacterial infections. With its unique pharmacokinetic profile, AUGMENTIN XR offers extended-spectrum coverage coupled with improved patient compliance. Understanding its market dynamics and financial trajectory is crucial for stakeholders across pharmaceutical companies, healthcare providers, and investors.

Pharmacological Profile and Therapeutic Position

AUGMENTIN XR’s formulation allows for once-daily dosing, enhancing adherence in outpatient settings. Its efficacy against resistant bacterial strains makes it a preferred choice for complicated sinusitis, urinary tract infections, and pneumonia. The drug’s extended-release technology ensures steady plasma concentrations, reducing dosing frequency and potentially limiting adverse effects. These pharmacological advantages sustain its relevance amid evolving antimicrobial resistance patterns.

Market Landscape and Competitive Environment

Global Market Size and Growth Prospects

The global antibiotics market, valued at approximately USD 43 billion in 2022, is projected to grow steadily at a CAGR of 3-5% through 2030 [1]. AUGMENTIN XR holds a significant share within the extended-spectrum penicillin segment, driven by its proven clinical efficacy. The rising burden of antibiotic-resistant infections and increasing outpatient prescriptions favorably influence demand.

Regional Market Dynamics

• North America: Leading in adoption due to high antibiotic consumption and robust healthcare infrastructure. The U.S. accounts for over 40% of the global antibiotics market, with extensive use of AUGMENTIN XR in outpatient settings.
• Europe: Regulatory acceptance and expanding antimicrobial stewardship programs impact prescription patterns. Market growth remains steady but constrained by antibiotic resistance concerns.
• Asia-Pacific: Rapid healthcare infrastructure development, rising prevalence of bacterial infections, and favorable reimbursement policies contribute to accelerated growth. Countries like China and India witness surges in antibiotics demand.

Competitive Landscape

AUGMENTIN XR faces competition from other extended-spectrum antibiotics such as cefdinir, amoxicillin-clavulanate formulations, and emerging biosimilar products. Key competitors include Pfizer’s Zosyn (piperacillin-tazobactam) and Merck’s Clarinex. Patent expirations and generic entries further intensify market competition, impacting pricing and revenue streams.

Regulatory and Reimbursement Factors

Regulatory agencies, notably the FDA and EMA, periodically review antimicrobial approvals, impacting market access. The approval of AB-rated generics and biosimilars exerts downward pricing pressures. Additionally, reimbursement policies influence prescribing behaviors, with insurance coverage significantly affecting drug uptake.

Financial Trajectory and Revenue Drivers

Historical Revenue Trends

Major pharmaceutical companies report steady revenue streams from AUGMENTIN XR, attributable to its clinical efficacy and once-daily dosing advantage. For instance, GlaxoSmithKline (GSK), the primary licensee, reported approximately GBP 1.2 billion (~USD 1.6 billion) in sales from AUGMENTIN products in their 2022 earnings [2].

Forecasted Financial Growth

Forecasts project a compound annual growth rate (CAGR) of 4-6% for AUGMENTIN XR-specific revenue through 2030, driven by:

• Expanding Patient Base: Increase in outpatient prescriptions, especially in emerging markets.
• Rising Antimicrobial Resistance (AMR): Spurring demand for broad-spectrum antibiotics.
• Innovative Formulations: Adoption of extended-release technology enhances therapeutic compliance, fostering continued utilization.

Pricing and Market Penetration Strategies

Premium pricing is maintained through demonstrated clinical benefit and patented sustained-release technology. Market penetration strategies include:

• Expanding indications and off-label uses.
• Developing pediatric and adult formulations.
• Collaborating with healthcare providers for antimicrobial stewardship programs.

Impact of Generic Competition and Patent Expiration

Patent expirations for specific AUGMENTIN XR formulations threaten revenue streams. The entry of generics typically reduces prices by 50-70%, impacting profitability. Strategic patent protections and formulation enhancements aim to prolong market exclusivity.

Market Challenges and Opportunities

Challenges

• Antimicrobial Resistance: Threatens the long-term efficacy, prompting regulatory and clinical scrutiny.
• Regulatory Hurdles: Delays in approvals for new formulations may hinder growth.
• Pricing Pressures: Governments and payers leverage formulary negotiations to limit costs.

Opportunities

• Expanding Indications: Targeting resistant bacterial infections and new therapeutic areas.
• Digital Health Integration: Employing electronic prescribing to optimize usage.
• Emerging Markets: Growth in Asia-Pacific and Latin America presents untapped opportunities.

Conclusion

AUGMENTIN XR commands a stable yet competitive position within the global antibiotics market. Its financial trajectory benefits from ongoing demand in outpatient settings, particularly in the face of rising antimicrobial resistance. Strategic initiatives focusing on formulation innovation, geographic expansion, and antimicrobial stewardship are essential to sustain long-term profitability.

Key Takeaways

• AUGMENTIN XR remains a critical player within the extended-spectrum antibiotics segment, driven by its pharmacokinetic advantages.
• The global market is projected to grow modestly at a CAGR of 4-6%, with significant opportunities in emerging markets.
• Competition and patent expiration pose challenges; however, innovation and strategic positioning can mitigate these risks.
• Revenue growth hinges on expanding indications, optimizing pricing, and navigating regulatory landscapes.
• Antimicrobial resistance underscores both the demand for broad-spectrum agents like AUGMENTIN XR and the imperative for ongoing development.

FAQs

1. What are the primary factors influencing AUGMENTIN XR’s market growth?
   Increasing prevalence of bacterial infections, rising antimicrobial resistance, patient preference for convenient dosing, and expanding indications support market growth for AUGMENTIN XR.

2. How does antimicrobial resistance affect AUGMENTIN XR’s market prospects?
   Resistance patterns drive demand for potent, broad-spectrum antibiotics like AUGMENTIN XR but also lead to regulatory scrutiny and potential formulation updates to address evolving resistance.

3. What are the competitive advantages of AUGMENTIN XR over other antibiotics?
   Its extended-release formulation ensures once-daily dosing, enhanced compliance, and sustained plasma concentrations, making it ideal for outpatient management.

4. How does patent expiry impact the financial trajectories of AUGMENTIN XR?
   Patent expiration opens the market to generics, typically lowering prices and reducing revenue. Strategic patent protections and formulation innovations aim to extend exclusivity.

5. What emerging markets offer the most growth potential for AUGMENTIN XR?
   Countries in Asia-Pacific and Latin America are experiencing rapid healthcare development, increasing bacterial infection rates, and expanding access to antibiotics, thus presenting significant growth opportunities.

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Sources:
[1] MarketWatch. “Antibiotics Market Size, Share & Trends Analysis Report.” 2022.
[2] GSK Annual Report 2022.