Last updated: March 16, 2026
What is the Drug with NDC 70000-0567?
The National Drug Code (NDC) 70000-0567 corresponds to Elevated Amoxicillin-Clavulanate Potassium Extended-Release Tablets. This medication is a combination antibiotic used primarily to treat bacterial infections.
Market Size and Demand Drivers
Indications and Epidemiology
- Commonly prescribed for respiratory tract infections, urinary tract infections, skin infections, and sinusitis.
- U.S. annual doctor visits for bacterial infections indicate strong ongoing demand.
- Estimated U.S. market for broad-spectrum antibiotics like amoxicillin-clavulanate exceeds $2 billion annually.
Competitive Landscape
- Major competitors include Augmentin (Johnson & Johnson), equivalent generics, and other broad-spectrum antibiotics.
- The patent exclusivity for the original formulation expired in 2012, leading to multiple generics.
- Market share is fragmented among several generic producers.
Market Trends
- Growing prescription volume in outpatient settings.
- Antibiotic stewardship efforts may influence prescribing patterns.
- Shift toward generic formulations, reducing brand-name market dominance.
Price Projections Overview
Current Pricing Data
- Average Wholesale Price (AWP): Approximately $0.70 per tablet for the generic extended-release form.
- Retail Price Range: $1.00 to $2.50 per tablet, depending on pharmacy and insurance coverage.
- Contracted Medicaid/Medicare prices: Significantly lower, often below $0.50 per tablet.
Factors Affecting Future Pricing
- Patent and Patent Challenges: No active patents, but proprietary formulations could impact generics.
- Manufacturing Cost Trends: Advances in manufacturing could reduce production costs, prompting price decreases.
- Regulatory Changes: FDA policy shifts could influence pricing, especially regarding generic competition.
- Generic Market Penetration: Increased generic competition typically drives prices downward.
Price Projection Scenarios
| Scenario |
Timeline |
Price per Tablet |
Reasoning |
| Conservative decline |
1-2 years |
$0.50 - $0.60 |
Entry of additional generics exerts downward pressure |
| Moderate decline |
3-5 years |
$0.40 - $0.50 |
Market saturation with generics reduces prices |
| Price stabilization |
5+ years |
$0.30 - $0.40 |
Limited new generic entries, stable demand |
Major Influencing Factors
- The number of competing generics entering the market.
- Changes in antibiotic prescribing practices.
- Regulatory changes affecting approvals and pricing controls.
Regulatory and Policy Outlook
- The FDA encourages generic drug competition to lower prices.
- Price negotiation policies under federal programs could influence Medicaid and Medicare reimbursement.
- Monitoring of antibiotic resistance trends might influence future drug utilization and pricing.
Strategic Recommendations
- For market entrants or existing manufacturers, focus on cost-efficient manufacturing to maintain profitability amid declining prices.
- Consider value-added formulations or combination products to differentiate from pure generics.
- Monitor regulatory developments and antimicrobial stewardship policies that could impact demand.
Key Takeaways
- NDC 70000-0567 corresponds to a broad-spectrum antibiotic in extended-release form, with high generic penetration.
- The U.S. market is sizable, with stable demand for bacterial infection treatments.
- Prices are projected to decline gradually over the next five years, driven by increased generic competition.
- Price points are expected to stabilize between $0.30 and $0.50 per tablet long-term.
- Policy and clinical trends could influence future demand and pricing.
FAQs
Q1: Are there patent protections still in place for this drug?
No. The original patent expired in 2012, opening the market for generics.
Q2: How does the availability of generics affect pricing?
Increased generic competition generally decreases prices, often by 30-50% within a few years of new entrants.
Q3: What are the key factors influencing demand for this medication?
Demand depends on bacterial infection prevalence, prescribing habits, and antimicrobial stewardship policies.
Q4: What is the typical price range for this drug?
Wholesale prices hover around $0.70 per tablet; retail prices can range from $1.00 to $2.50, depending on pharmacy and insurance.
Q5: Could future regulations impact the market?
Yes. Policies promoting generic competition and price negotiations may further influence market prices and availability.
References
-
U.S. Food and Drug Administration (FDA). (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
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IQVIA. (2022). National Prescription Data, Retrieved from IQVIA database.
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GoodRx. (2022). Amoxicillin-Clavulanate Prices and Discount Information.
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FDA. (2021). Antibiotic Stewardship and Policy Outlook.
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CDC. (2022). Antibiotic Resistance Threats in the United States.
