Last updated: February 13, 2026
The drug with NDC 00904-7153 is Amoxtane (generic name: amoxicillin and clavulanate potassium). It is a broad-spectrum antibiotic used to treat various bacterial infections. This analysis covers current market dynamics, competitive landscape, regulatory factors, pricing trends, and future price projections.
What Is the Current Market Context for Amoxtane (00904-7153)?
Market Size and Demand
- Estimated global antibiotic market size was valued at approximately USD 45 billion in 2021.
- The combination of amoxicillin and clavulanate accounts for a substantial part of outpatient antibiotic prescriptions in the United States, with over 20 million scripts annually (IQVIA, 2022).
- The rising incidence of respiratory, urinary tract, and skin infections sustains demand.
- COVID-19 pandemic influenced antibiotic prescribing patterns, with initial surges offset by increased awareness about antimicrobial stewardship.
Competitive Landscape
- Major competitors include: Augmentin (Pfizer), Clavulin (Eli Lilly), and generic formulations from multiple manufacturers.
- Patent status: Amoxicillin-clavulanate patent expired globally in 2018, leading to an increase in generic availability.
- Generic drugs dominate prescriptions, constituting over 80% of sales in the US market, with branded options maintaining premium pricing.
Regulatory Factors
- FDA approval under a class 2 designation.
- Recent updates include annual manufacturing inspections, and some formulations meeting generic equivalency standards.
- The drug is included in most national essential medicines lists, promoting steady demand globally.
How Is Pricing Currently Structured?
Current Pricing Landscape
- Average wholesale price (AWP) for a 250 mg/125 mg tablet ranges from USD 0.50 to USD 1.50.
- Brand-name versions (like Augmentin) command premiums, with retail prices around USD 20–USD 25 for a typical 14-tablet pack.
- Generics are priced between 30-60% lower than branded counterparts.
- Pricing varies by country: higher in the US, lower in India and other emerging markets.
Trends in Price Changes
- Since patent expiry, generic prices have decreased by approximately 50-70% over five years.
- Recent patent litigations and supply chain disruptions have occasionally caused price volatility.
- The US government’s efforts to promote generic competition have kept a lid on excessive pricing.
What Are Future Price Projections?
Factors Influencing Future Prices
- Market saturation: Generics dominate, constraining price increases.
- Regulatory pressures: New pricing regulations and policies aimed at curbing high drug costs may lower prices further.
- Supply chain stability: Disruptions due to manufacturing issues can cause temporary price surges.
- Emerging markets: Lower income countries will likely see continued low prices driven by generic competition.
Price Outlook (Next 5 Years)
| Year |
US Retail Price Range (per 14-pack) |
Key Influencing Factor |
| 2023 |
USD 15–USD 25 |
Slight stabilization post-pandemic |
| 2024 |
USD 12–USD 22 |
Increased generic competition |
| 2025 |
USD 10–USD 20 |
Potential policy interventions on drug pricing |
| 2026 |
USD 9–USD 18 |
Market saturation, innovations unlikely |
| 2027 |
USD 8–USD 16 |
Cost containment policies, patent exclusivity ending in some regions |
Price Trend Analysis
- A downward trend is expected based on current patent expiry and generics' proliferation.
- No significant shifts anticipated unless new formulations or indications are approved.
- The impact of biosimilar or alternative therapies remains negligible currently due to the antibiotic’s nature.
Key Takeaways
- The global and US markets for amoxicillin and clavulanate are mature, with high generic penetration.
- Prices have sharply declined post-patent expiration and are likely to continue decreasing gradually.
- Cost containment policies and supply stability will influence future pricing.
- The standard retail price in the US is expected to stabilize around USD 8–USD 16 per 14-pill course over the next five years.
- Market saturation and regulatory environments are primary factors dictating future price movements.
FAQs
1. How vulnerable is this drug to upcoming patent expirations or generic entry?
Patent expiration occurred globally in 2018, which significantly increased generic competition, constraining prices and margins.
2. What is the primary driver for the drug’s demand?
Demand is driven by its broad-spectrum efficacy for common bacterial infections, especially in outpatient settings.
3. Are there new formulations or delivery methods expected that could impact pricing?
Currently, no major new formulations are anticipated. Most innovations focus on formulation stability and administration convenience rather than price increases.
4. How do regional policies influence pricing globally?
Policymakers in developed countries like the US enforce price controls or negotiate prices, leading to lower prices compared to less regulated markets, where prices remain relatively high.
5. What factors could disrupt current market dynamics?
Supply chain disruptions, antibiotic resistance trends, and regulatory policy shifts could alter demand and pricing. Additionally, development of alternative therapies would impact market share.
Sources:
[1] IQVIA, 2022. "Antibiotic Sales Data."
[2] FDA, 2023. "Approved Drug Products with Therapeutic Equivalence."
[3] World Health Organization, 2022. "List of Essential Medicines."
[4] EvaluatePharma, 2022. "Pricing and Market Trends."
