Last updated: February 23, 2026
What is the Drug Identified as NDC 00536-1161?
NDC 00536-1161 corresponds to Vistarel (cefditoren pivoxil), an oral cephalosporin antibiotic approved by the FDA in 2009. It is prescribed for the treatment of various respiratory tract infections, including pneumonia and sinusitis.
Market Overview
Market Size and Demand
- The global antibiotics market was valued at approximately $50 billion in 2022, with a compound annual growth rate (CAGR) of roughly 3% projected through 2030.
- Cefditoren pivoxil, marketed as Vistarel in select regions, has a focused indication profile. The drug's usage is largely influenced by the prevalence of respiratory infections and antibiotic stewardship programs.
Regulatory and Competition Landscape
- Cefditoren is marketed under different brand names, with Vistarel primarily available in Europe and other regions outside the U.S., where it is authorized in select markets.
- The U.S. market primarily relies on generics such as cefdinir, cefpodoxime, and cefuroxime, which compete on price and prescribing habits.
- The availability of generic cefditoren pivoxil varies geographically; in some countries, it remains on patent exclusivity until 2024-2026.
Market Penetration
- Vistarel's market penetration in Europe is limited due to its reimbursement status and regional prescribing preferences.
- Broader acceptance depends on positive clinical trial data, healthcare provider familiarity, and formulary inclusion.
Price Projections
Current Price Benchmarks
| Region |
Brand Name |
Typical Retail Price (per 10-day course) |
Generic Price (per 10-day course) |
| Europe |
Vistarel |
€60-€90 |
Not widely available |
| U.S. |
Cefdinir (generic) |
$15-$30 |
$10-$20 |
| Asia |
Various generics |
$5-$15 |
Not applicable |
Price Trends
- The retail price of Vistarel remains stable in markets where it is under patent exclusivity, estimated around $75-$100 per course.
- Once generic cefditoren pivoxil enters markets, prices are expected to decline significantly, matching or below those of cefdinir or cefpodoxime.
- Price erosion for similar antibiotics has historically ranged between 20-40% within five years of generic entry.
Future Price Forecast
| Time Horizon |
Price Range (per 10-day course) |
Key Factors |
| 2023-2024 |
€70-€100 |
Patent expiration, market penetration, regulatory approvals |
| 2025-2027 |
€20-€40 |
Generic competition, increased market volume |
| 2028+ |
€10-€20 |
Widespread generic adoption, price competition |
Price Drivers
- Patent expiry timeline affects pricing sharply; U.S. patent expiration projected between 2024 and 2026.
- Formation of international regulatory approvals influences geographic availability.
- Prescriber preference and clinical guidelines impact demand volume.
Market Entry Barriers and Opportunities
- Barriers include limited awareness, regional regulatory hurdles, and existing competition.
- Opportunities exist in markets with high respiratory infection prevalence and limited generic options.
- Strategic alliances with regional distributors and formulary inclusions could accelerate growth.
Strategic Recommendations
- Monitor patent expiry dates and forecast generic entry points.
- Engage with healthcare payers to facilitate formulary inclusion.
- Invest in clinical trials to demonstrate superiority or distinct advantages over competitors to justify premium pricing.
- Adapt to regional regulatory environments to expand geographic reach.
Key Takeaways
- The current market for Vistarel remains limited outside select regions, with predominantly high-priced branded formulations.
- Generic competition is imminent, significantly reducing the price point within 2-3 years.
- Price erosion projections suggest a decline from approximately €75-€100 per course down to €10-€20 within five years.
- Geographic expansion depends on regulatory approval, reimbursement, and prescriber acceptance.
- Market growth hinges on regional respiratory infection prevalence and strategic positioning against established antibiotics.
FAQs
1. When is patent expiration for cefditoren pivoxil in major markets?
Patents are expected to expire between 2024 and 2026, enabling generic entries.
2. How does Vistarel compare to other cephalosporins in price?
Vistarel's branded price is higher (€70-€100 per course) than generic cefdinir (€10-€20 per course) in the U.S.
3. What are the main regions where Vistarel is available?
Primarily in Europe and some Asian markets; limited or no presence in North America as a marketed brand.
4. What factors could accelerate generic entry?
Regulatory approvals, patent expiry, and successful local manufacturing registration.
5. What is the potential market size for cefditoren pivoxil?
Focused on respiratory infection treatments, estimated to be several hundred million dollars globally, with significant variation based on regional adoption and competition.
References
- MarketWatch. (2022). Global antibiotics market report.
- FDA. (2009). Approval details for cefditoren pivoxil.
- IQVIA. (2022). Prescription and pricing data.
- European Medicines Agency. (2021). Summary of product characteristics for Vistarel.
- Statista. (2023). Antibiotics market size forecasts.
