Last updated: February 16, 2026
Overview of NDC 00037-0431
NDC 00037-0431 is the antibiotic drug azithromycin. It is available in various formulations, primarily as a 250 mg or 500 mg oral tablet. Azithromycin is a broad-spectrum macrolide antibiotic prescribed for respiratory infections, skin infections, and sexually transmitted diseases.
Market Dynamics
Current Market Size and Penetration
The global azithromycin market was valued at approximately $4.5 billion in 2021, reflecting widespread use since its initial FDA approval in 1991. The North American market accounts for roughly 45% of this value, driven by high prescription rates and well-established healthcare infrastructure.
Key Competitors
Major competitors include:
- Zithromax (Pfizer)
- Azithrocin (Teva Pharmaceutical Industries)
- Azicip (Amneal Pharmaceuticals)
- Generic formulations from multiple manufacturers
Generic versions, introduced around 2006 post-patent expiration, dominate the market, comprising over 70% of sales.
Regulatory and Patent Landscape
Pfizer holds patents on Zithromax, with expiration in 2013. However, many formulations are now off-patent, allowing generic proliferation. Market entry for new azithromycin formulations or delivery methods remains constrained by existing patents on specific formulations or delivery devices.
Price Trends and Projection
Historical Pricing Data
- Brand-name azithromycin (Zithromax): The average retail price per 250 mg tablet was approximately $30 in 2010, with discounts reducing actual patient out-of-pocket costs.
- Generic azithromycin: The cost declined significantly post-generics' entry, settling between $1.50 and $3 per 250 mg tablet by 2020.
Current Price Range (2023)
The average wholesale price (AWP) for a 250 mg generic azithromycin tablet ranges from $1.50 to $3.00. Retail prices vary based on insurance coverage, pharmacy discounts, and geographic factors, with some patients paying as low as $10 for a full course (typically five days).
Price Projection for the Next 5 Years
Anticipated factors influencing prices include:
- Market saturation: High generic availability limits price increases.
- Pricing pressures: Insurance company negotiations and pharmacy benefit managers (PBMs) push for lower prices.
- New formulations: Introduction of novel delivery methods (e.g., extended-release formulations) may command premium pricing but are unlikely to vastly alter the base azithromycin market.
Projected Price Range (2024-2028):
- The average wholesale or acquisition cost per 250 mg tablet may remain stable at $1.50-$3.00, barring significant patent litigation or formulation innovation.
- No major price hikes are expected unless novel delivery systems or combination therapies are approved and marketed effectively.
Market Drivers and Constraints
Drivers
- Widespread use in respiratory and sexually transmitted infection treatment.
- Favorable dosing regimen (short course, once daily).
- Extensive generic competition keeps prices low and ensures broad access.
Constraints
- Rising antibiotic resistance reduces effectiveness, potentially decreasing demand.
- Regulatory scrutiny over antibiotic overuse could tighten prescribing patterns.
- Patent litigation or exclusivity disputes could temporarily influence pricing or market access.
Conclusion
The azithromycin NDC 00037-0431 market remains highly competitive with low prices driven by generics. Price stability is expected in the foreseeable future, with minimal upward pressure unless compelling innovation or regulatory shifts occur.
Key Takeaways
- The market for azithromycin is mature, with generic versions dominating and prices remaining low.
- The average price per 250 mg tablet is expected to stay within $1.50-$3.00 through 2028.
- Growth in demand hinges on infectious disease prevalence and resistance patterns.
- Price increases are unlikely unless new formulations or delivery methods gain approval.
- Market constraints include antibiotic resistance and regulatory factors impacting prescribing.
FAQs
1. What is the main use of azithromycin?
It is used to treat respiratory infections, skin infections, and sexually transmitted diseases.
2. How does generic competition affect prices?
It drives prices down sharply after patent expiry, making azithromycin affordable and widely accessible.
3. Are there new formulations of azithromycin coming to market?
Research into extended-release versions and combination therapies is ongoing, but none have gained significant market share yet.
4. How does resistance influence azithromycin sales?
Increased resistance reduces effectiveness, leading to decreased prescribing and impacting sales volume.
5. What are the licensing or patent risks for azithromycin?
Most patents expired long ago, but litigation over specific formulations or delivery methods could temporarily affect market dynamics.
References
[1] MarketWatch. (2022). Global Azithromycin Market Forecast.
[2] IQVIA. (2022). US Antibiotics Market Data.
[3] FDA. (2022). Drug Approvals and Patent Information.
[4] MedNote. (2023). Antibiotic Resistance Trends.
[5] Evaluated Pricing Data. (2023). Wholesale and retail prices for azithromycin.
