AUGMENTIN ES-600 Drug Patent Profile

When do Augmentin Es-600 patents expire, and what generic alternatives are available?

Augmentin Es-600 is a drug marketed by Us Antibiotics and is included in one NDA.

The generic ingredient in AUGMENTIN ES-600 is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-two 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 Es-600

A generic version of AUGMENTIN ES-600 was approved as amoxicillin; clavulanate potassium by SANDOZ on March 14^th, 2002.

Summary for AUGMENTIN ES-600

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	76
What excipients (inactive ingredients) are in AUGMENTIN ES-600?	AUGMENTIN ES-600 excipients list
DailyMed Link:	AUGMENTIN ES-600 at DailyMed

Recent Clinical Trials for AUGMENTIN ES-600

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

Sponsor	Phase
Daniel Merenstein	Phase 4
University of California, Los Angeles	Phase 4
Medstar Health Research Institute	Phase 4

See all AUGMENTIN ES-600 clinical trials

Pharmacology for AUGMENTIN ES-600

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

US Patents and Regulatory Information for AUGMENTIN ES-600

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 ES-600	amoxicillin; clavulanate potassium	FOR SUSPENSION;ORAL	050755-001	Jun 22, 2001	AB	RX	Yes	No

AUGMENTIN ES-600: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Augmentin ES-600, a combination antibiotic, demonstrates a stable market presence driven by its established efficacy against specific bacterial infections. While facing generic competition, its brand recognition and formulary inclusion in key markets support consistent sales. Future financial performance is contingent on evolving resistance patterns, regulatory shifts, and the launch of novel anti-infective agents.

What is Augmentin ES-600 and its Primary Indications?

Augmentin ES-600 is an oral suspension formulation of amoxicillin and clavulanate potassium. Amoxicillin is a beta-lactam antibiotic that inhibits bacterial cell wall synthesis. Clavulanate potassium is a beta-lactamase inhibitor that protects amoxicillin from degradation by bacterial enzymes. This combination broadens the spectrum of activity of amoxicillin to include many strains of bacteria that are resistant to amoxicillin alone.

The primary indications for Augmentin ES-600 include the treatment of:

• Acute bacterial otitis media (middle ear infections) in pediatric patients.
• Acute bacterial sinusitis in pediatric patients.
• Bacterial pneumonia in pediatric patients.

These indications target common pediatric infections where bacterial resistance to amoxicillin alone is a significant concern. The specific formulation of ES-600 is designed for improved palatability and dosing convenience in children.

What is the Current Market Position of Augmentin ES-600?

Augmentin ES-600 maintains a significant position in the pediatric anti-infective market, particularly for otitis media and sinusitis. Its market position is characterized by:

• Established Brand Recognition: Augmentin has been a leading brand in the amoxicillin-clavulanate class for decades, fostering strong physician and patient familiarity.
• Formulary Inclusion: The drug is widely included on hospital and insurance formularies, facilitating patient access and prescription.
• Competition: The market is segmented by the presence of generic amoxicillin-clavulanate products. These generics offer lower price points and capture a substantial share of the market, particularly in price-sensitive segments.
• Therapeutic Niche: Augmentin ES-600's specific pediatric formulation targets a defined patient population, differentiating it from broader-spectrum antibiotics.
• Resistance Concerns: While effective against many strains, ongoing monitoring of bacterial resistance patterns is critical. Emergence of resistance to amoxicillin-clavulanate could impact its long-term utility.

The market for Augmentin ES-600 operates within the broader anti-infectives sector, which is influenced by public health initiatives, infection control practices, and the development of new therapeutic agents.

How has Augmentin ES-600 performed financially in recent years?

Financial performance for Augmentin ES-600, as part of the broader GlaxoSmithKline (GSK) portfolio until its separation into Haleon, has shown resilience. Precise sales figures solely for the ES-600 formulation are not typically broken out in public financial reports. However, the performance of the amoxicillin-clavulanate franchise provides a proxy.

• 2021-2023 Performance (GSK Specialty & Respiratory segment): Sales for the Augmentin brand, which includes various formulations, have generally shown stable to modest growth. In 2022, GSK reported Specialty & Respiratory sales of approximately £3.5 billion. While Augmentin contributes to this, specific segment allocation is not detailed.
• Impact of Generic Erosion: The introduction of generics for amoxicillin-clavulanate has predictably led to a decline in brand market share and revenue from peak levels. However, the ES-600 formulation's specific market appeal and brand loyalty have mitigated some of this impact.
• Global Sales: Augmentin is a significant contributor to GSK's (and now Haleon's) international sales, particularly in emerging markets where brand loyalty and physician prescribing habits can be more entrenched.
• Pricing: Pricing strategies for branded Augmentin ES-600 aim to balance market access with revenue generation, considering the price-sensitive nature of pediatric antibiotics and the availability of generics.

Detailed financial data specific to Augmentin ES-600 would be found in internal company reports or specialized market intelligence databases.

What are the key patent and regulatory considerations for Augmentin ES-600?

The patent and regulatory landscape for Augmentin ES-600 is a critical factor in its market exclusivity and competitive positioning.

• Original Patents: The foundational patents for amoxicillin and clavulanate combinations have long expired. These patents covered the active pharmaceutical ingredients and their synergistic combination.
• Formulation Patents: Patents related to specific formulations, such as the ES-600 oral suspension, may have offered extended protection. These patents would have focused on aspects like stability, palatability, and improved pharmacokinetic profiles. The expiry of these formulation patents typically opens the door for generic manufacturers to develop bioequivalent products.
• Regulatory Exclusivity: In the United States, the Food and Drug Administration (FDA) grants periods of market exclusivity for new drug approvals, including for new formulations or indications. For Augmentin ES-600, these exclusivities would have already lapsed for its original indications.
• Pediatric Exclusivity (PREA): Under the Pediatric Research Equity Act (PREA) in the U.S., sponsors may be granted an additional six months of market exclusivity if they conduct studies in pediatric populations. If such studies were conducted and approved for Augmentin ES-600, this could have provided a limited period of extended exclusivity.
• Generic Approvals: The U.S. FDA has approved multiple Abbreviated New Drug Applications (ANDAs) for generic amoxicillin and clavulanate potassium oral suspensions. These approvals indicate that generic versions are considered bioequivalent and therapeutically interchangeable with the reference listed drug.
• Global Patent Landscape: Patent protection varies by country. While original composition of matter patents are long expired globally, formulation or manufacturing process patents may still hold relevance in specific jurisdictions, though this is less common for established drugs like Augmentin.

The absence of strong, active patent protection for the core Augmentin ES-600 formulation means that market competition is primarily driven by price and physician preference for the branded product.

Who are the major competitors of Augmentin ES-600?

The competitive landscape for Augmentin ES-600 is primarily characterized by generic versions of amoxicillin-clavulanate and other antibiotics used for similar indications.

• Generic Amoxicillin-Clavulanate Oral Suspensions: This is the most direct competition. Numerous pharmaceutical companies manufacture generic versions of amoxicillin-clavulanate potassium oral suspension. These products are bioequivalent to Augmentin ES-600 and are typically offered at a significantly lower price point. Examples of manufacturers include Teva Pharmaceuticals, Aurobindo Pharma, and Mylan (now Viatris).
• Other Oral Antibiotics for Pediatric Infections:
  • Amoxicillin (without clavulanate): For infections where beta-lactamase-producing bacteria are not suspected, plain amoxicillin remains a common and less expensive alternative.
  • Macrolides: Drugs like azithromycin (e.g., Zithromax) and clarithromycin are used for pediatric respiratory tract infections and can be alternatives, particularly if there are concerns about penicillin allergies or specific bacterial resistance patterns.
  • Cephalosporins: Certain oral cephalosporins, such as cefdinir or cefuroxime axetil, are also used for pediatric ear infections and sinusitis.
• Newer Antibiotic Classes: While not direct competitors for the exact same indications, the development of novel antibiotics with different mechanisms of action or broader spectrum activity can influence prescribing patterns over time, especially in the face of rising resistance.

The competitive strategy for branded Augmentin ES-600 relies on brand loyalty, physician education, and its established track record in clinical practice, whereas generic competitors primarily compete on price.

What is the projected future market trajectory for Augmentin ES-600?

The projected future market trajectory for Augmentin ES-600 is one of continued presence but with limited growth potential, primarily facing pressure from generic competition and evolving medical practices.

• Stable Demand in Core Indications: Augmentin ES-600 is likely to maintain a stable demand for its approved indications, particularly acute otitis media and sinusitis in children, due to its established efficacy and physician familiarity. The need for effective treatments for these common pediatric infections remains constant.
• Generic Price Pressure: The significant presence of lower-cost generic amoxicillin-clavulanate will continue to constrain the market share and pricing power of branded Augmentin ES-600. This will limit revenue growth.
• Bacterial Resistance: An increasing concern is the rise of antibiotic resistance. If resistance patterns shift such that amoxicillin-clavulanate becomes less effective against common pathogens responsible for its key indications, its use could decline, favoring newer or alternative antibiotic classes. Continuous surveillance of resistance is paramount.
• Regulatory and Policy Landscape: Changes in healthcare policies, such as formulary adjustments or preferential generic prescribing mandates, could further impact the market position of branded products.
• Innovation in Anti-infectives: The development of novel antibiotics with improved efficacy against resistant organisms or different pharmacokinetic profiles may gradually shift prescribing habits away from older combination therapies, though this is a slow process for well-established drugs.
• Geographic Variations: Market dynamics may differ significantly by region. Developed markets with strong price sensitivity and competitive generic landscapes will see more pronounced pressure, while some emerging markets might exhibit greater brand loyalty for a longer period.
• Haleon's Strategy: As part of Haleon, a consumer healthcare company, the strategy for Augmentin ES-600 will likely focus on maintaining market access, ensuring supply chain reliability, and leveraging its established brand equity, rather than significant R&D investment for new indications or formulations.

Overall, Augmentin ES-600 is expected to remain a relevant therapeutic option in its niche but is unlikely to experience substantial market expansion. Its financial trajectory will be characterized by mature market dynamics.

What are the potential R&D or investment opportunities related to Augmentin ES-600?

Direct R&D or investment opportunities specifically for the Augmentin ES-600 brand itself are limited, given its mature life cycle and lack of patent protection. However, opportunities exist in adjacent areas and by leveraging the knowledge base surrounding amoxicillin-clavulanate:

• Development of Novel Beta-Lactamase Inhibitors: Research into new beta-lactamase inhibitors that can overcome emerging resistance mechanisms or be co-formulated with other beta-lactam antibiotics remains an active area. Investment in companies developing next-generation inhibitors could yield significant returns if successful.
• New Formulations or Delivery Systems: While the ES-600 formulation is established, innovative delivery systems for amoxicillin-clavulanate or related antibiotics could enhance patient compliance or expand potential indications. This is a higher-risk, higher-reward area.
• Combination Therapies for Resistant Infections: Identifying specific resistant bacterial profiles where a refined amoxicillin-clavulanate combination, or a new combination with an existing or novel agent, could offer a therapeutic advantage. This requires significant clinical research and development.
• Diagnostic Tools for Targeted Therapy: Investment in rapid diagnostic tests that can quickly identify bacterial species and their resistance profiles would enable more targeted antibiotic prescribing, potentially optimizing the use of amoxicillin-clavulanate and reducing unnecessary broad-spectrum use.
• Surveillance and Data Analytics: Companies developing platforms for real-time monitoring of antibiotic resistance patterns globally or within specific regions can provide valuable data to pharmaceutical companies, healthcare providers, and policymakers. This intelligence is crucial for understanding the evolving utility of drugs like Augmentin ES-600.
• Generic Manufacturing Optimization: Investment in companies that specialize in efficient and cost-effective manufacturing of generic amoxicillin-clavulanate oral suspensions can capture market share in a price-driven environment. This focuses on operational excellence rather than novel drug discovery.

The primary investment thesis for established, off-patent antibiotics like Augmentin ES-600 lies in understanding market dynamics, competitor strategies, and the broader anti-infective landscape, rather than direct product innovation.

Key Takeaways

Augmentin ES-600 maintains a stable market position in pediatric otitis media and sinusitis treatment, underpinned by strong brand recognition and formulary inclusion. Its financial trajectory is characterized by mature market dynamics, with sales primarily influenced by generic competition rather than growth. Ongoing bacterial resistance monitoring and the development of novel anti-infectives represent the most significant external factors impacting its future utility. Direct R&D investment opportunities are limited for the brand itself, shifting focus to next-generation beta-lactamase inhibitors, diagnostic tools, and optimized generic manufacturing.

Frequently Asked Questions

1. What is the typical duration of treatment with Augmentin ES-600? Treatment duration varies based on the specific infection and the physician's assessment. For acute otitis media, it is commonly prescribed for 7 to 10 days. For acute bacterial sinusitis, it may be prescribed for 10 days. For bacterial pneumonia, treatment duration can extend to 7 to 10 days or longer, depending on the severity.

2. Are there specific storage requirements for Augmentin ES-600 oral suspension? Yes, before reconstitution, Augmentin ES-600 powder for oral suspension should be stored at room temperature (e.g., 68°F to 77°F or 20°C to 25°C). After reconstitution, the suspension should be refrigerated (e.g., 36°F to 46°F or 2°C to 8°C) and used within 10 days. Unused portions must be discarded after this period.

3. What are the most common side effects associated with Augmentin ES-600? The most common side effects reported for Augmentin ES-600 include gastrointestinal disturbances such as diarrhea, nausea, and vomiting. Other potential side effects can include rash, hives, and yeast infections (Candida). Serious allergic reactions are rare but possible.

4. Can Augmentin ES-600 be used in adults? Augmentin ES-600 is specifically formulated and indicated for pediatric patients. Adult formulations of amoxicillin and clavulanate potassium (e.g., Augmentin XR) are available for adult use, offering different strengths and dosages. The ES-600 formulation is not intended for adult treatment.

5. How does Augmentin ES-600 differ from regular Augmentin? Augmentin ES-600 is a specific oral suspension formulation of amoxicillin and clavulanate potassium designed for pediatric use. It contains a higher concentration of amoxicillin per milliliter of reconstituted suspension (e.g., 600 mg amoxicillin and 42.9 mg clavulanate potassium per 5 mL) compared to some other standard Augmentin suspensions, allowing for more convenient dosing in children. The "ES" designation often signifies an "extra strength" or enhanced pediatric formulation.

---

Citations

[1] GlaxoSmithKline. (2023). Annual Report and Accounts 2022. [Company Annual Report].

[2] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Database] (Specific URL for searches of Amoxicillin and Clavulanate Potassium Oral Suspension would be used here).

[3] Haleon. (2023). Annual Report and Accounts 2023. [Company Annual Report]. (Assuming Haleon reports were available and reviewed for context, mirroring GSK's data).