Last updated: February 20, 2026
What Is the Drug Associated with NDC 62559-0631?
NDC 62559-0631 corresponds to Clarithromycin 500 mg tablets, a macrolide antibiotic used primarily to treat respiratory tract infections, skin infections, and Helicobacter pylori infections.
Market Overview
Therapeutic Market Size
- Global antibiotics market size was valued at approximately $51 billion in 2021.
- The respiratory antibiotics segment, including clarithromycin, accounts for roughly 30% of this market.
- Growth is driven by increasing antibiotic resistance, emerging markets, and expanding indications.
Market Drivers
- Rising prevalence of respiratory diseases such as pneumonia and bronchitis.
- Increasing Helicobacter pylori infections worldwide.
- Growing antibiotic resistance leading to new formulation and combination therapies.
- Patent expiration of several clarithromycin formulations, opening generic markets.
Competitive Landscape
- Major brands include Biaxin (AbbVie), Clarithromycin Sandoz (Novartis), and generic manufacturers.
- Patent expiration for Biaxin in multiple territories has increased generic penetration.
- The entry of new antibiotics targeting resistant strains may impact clarithromycin's market share.
Regulatory Environment
- Several countries have tightened regulations on antibiotic prescribing to combat resistance.
- Approval for generic versions in the US by FDA, CE marking in Europe, and similar approvals globally.
Price Analysis
Historical Pricing Trends
- Brand-name clarithromycin: Retail prices have ranged between $10-$20 per 500 mg tablet.
- Generic formulations: Prices range from $1-$5 per pill, depending on manufacturer and purchase volume.
- Insurance reimbursement: Generally covers generic formulations, reducing out-of-pocket costs.
Current Market Prices (US, as of 2023)
| Drug Type |
Average Wholesale Price (AWP) |
Approximate Retail Price (ARP) |
Typical Insurance Reimbursement |
| Brand name |
$12.50 per tablet |
$20 per tablet |
Covered, with patient copay often <$10 |
| Generic |
$1.50 per tablet |
$3 per tablet |
Covered, copays generally <$5 |
Price Projections (Next 2-5 Years)
- Generic price decline: Expected to decrease further due to increased market penetration and competition.
- Average price forecast: $0.50–$1.00 per tablet by 2028 in the US.
- Brand-name premium: Likely to persist at $10–$15 per tablet unless patent protection is reestablished or new formulations emerge.
Key Factors Impacting Market and Pricing
- Patent and Exclusivity Status: No patent protection remains; generics dominate.
- Resistance Patterns: Rising resistance could reduce usage, impacting sales volume.
- Regulatory Changes: Stringent prescribing guidelines could lower consumption.
- Manufacturing and Supply Chain: Disruptions may influence pricing and availability.
- Emergence of Alternatives: New antibiotics or combination therapies targeting resistant strains could replace clarithromycin.
Summary
- Clarithromycin (NDC 62559-0631) faces a mature generic market with declining retail prices.
- US wholesale prices trend downward, with generics near $0.50–$1.00 per tablet by 2028.
- Volume shifts driven by resistance trends and regulatory changes will heavily influence revenue.
- Brand products will maintain a premium, but overall market share is expected to shrink.
Key Takeaways
- Clarithromycin has broad indications, but budget constraints and resistance issues challenge sustained growth.
- Prices are decreasing due to generic competition; the market is highly price-sensitive.
- Regulatory policies targeting antibiotic stewardship can impact prescribing patterns.
- Future profitability hinges on resistance management and potential new formulations.
- Global expansion, particularly in emerging markets, offers growth opportunities despite pricing pressures.
FAQs
1. What factors influence clarithromycin pricing the most?
Price is primarily driven by generic competition, regulatory policies, and resistance trends.
2. How might resistance affect the clarithromycin market?
Increased resistance reduces clinical efficacy, which can lower demand and lead to market decline.
3. Are there any significant patent-related advantages remaining for clarithromycin?
No, patent protections have expired, paving the way for generic manufacturers.
4. How do regulatory policies impact future pricing?
Stricter prescribing guidelines and antimicrobial stewardship programs can decrease sales volume, influencing prices downward.
5. Will brand-name clarithromycin retain premium pricing?
Likely, if patents reissue or new formulations emerge. Otherwise, generics dominate due to cost-efficiency.
References
- MarketsandMarkets. (2022). Antibiotics market size and forecast.
- IQVIA. (2023). US Prescription Drug Market Data.
- FDA. (2022). Drug approvals and patent data.
- WHO. (2022). Global antimicrobial resistance report.
- Statista. (2023). Antibiotics sales and pricing trends globally.
