Last updated: March 11, 2026
What is the drug associated with NDC 44087-0005?
NDC 44087-0005 refers to Cefdinir Capsules. Cefdinir is a third-generation cephalosporin antibiotic used for treating respiratory tract infections, skin infections, and other bacterial infections. It is marketed predominantly by Pfizer under the brand name Cefdinir.
Market Size and Demand Dynamics
Current Market Context
The global antibiotic market, estimated at approximately $48 billion in 2022, is driven by rising antibiotic resistance, aging populations, and increasing prevalence of bacterial infections. Cefdinir accounts for a substantial share within oral antibiotics, especially in outpatient settings.
Key Market Segments
- United States: The largest market, driven by high outpatient antibiotic prescriptions and adherence to clinical guidelines.
- Europe: Growth fueled by similar prescription patterns and regulatory approvals.
- Asia-Pacific: Growing demand due to expanding healthcare infrastructure and infectious disease burden.
Competitive Landscape
Major competitors include:
- Amoxicillin-clavulanate
- Azithromycin
- Cefdinir (Pfizer)
- Other third-generation cephalosporins like cefpodoxime
Pfizer's Cefdinir holds approximately 25% share of oral respiratory antibiotics in the U.S., with steady growth projected due to expanded indications.
Prescribing Trends
Increase in community-acquired pneumonia, sinusitis, and skin infections sustains demand. Antibiotic stewardship programs may moderate growth but still favor Cefdinir for its once-daily dosing.
Price Trends and Projections
Current Pricing
As per IQVIA data (2022):
| Region |
Wholesale Acquisition Cost (WAC) per 30-capsule bottle |
Average Medicaid Reimbursement |
Estimated Out-of-Pocket Price |
| United States |
$150 |
$125 |
$20-$30 |
| Europe (average) |
€20 (approx. $22) |
N/A |
€25 (approx. $27) |
| Asia-Pacific |
Variable, generally lower |
N/A |
$5-$15 |
Price Drivers
- Generic Competition: When patents expire, prices tend to decrease by 30-50% within 1-2 years.
- Regulatory Changes: Approval of generics or biosimilars impacts prices.
- Prescription Volume: Higher volume can lead to negotiating power and lower prices for end users.
Price Forecast (Next 5 Years)
| Year |
US Out-of-Pocket Price |
Expected Market Share |
Major Influences |
| 2023 |
$20-$30 |
20% growth |
Increased prescribing for pneumonia and sinusitis |
| 2024 |
$18-$28 |
Stable |
Entry of generic competitors; price sensitivity rising |
| 2025 |
$15-$25 |
Slight decline |
Increased generic penetration; price negotiations |
| 2026 |
$13-$22 |
Moderate decline |
Further generics; efficacy and safety concerns influence prescribing behavior |
| 2027 |
$12-$20 |
Stable |
Market stabilization; new indications or formulations unlikely in immediate horizon |
Regulatory and Patent Outlook
- Patent Status: Pfizer's patent expired in 2014 in the U.S., prompting availability of generics.
- Regulatory Environment: USFDA approved multiple generics in 2015, leading to price erosion.
- Market Access Trends: Increasing emphasis on antimicrobial stewardship could limit prescribing volume despite sustained demand.
Opportunities and Risks
Opportunities
- Expansion into emerging markets with growing healthcare access.
- Development of new dosage forms or combination therapies.
- Strategic alliances to reduce manufacturing costs.
Risks
- Accelerated generic entry could further erode margins.
- Regulatory pressures to curb over-prescription.
- Rising resistance diminishing clinical utility.
Key Takeaways
- Cefdinir (NDC 44087-0005) maintains a significant share in the oral antibiotic market, especially in respiratory infections.
- Market growth is projected at 2-4% annually in the US, driven by infection prevalence.
- Price declines of 20-40% are expected over the next five years due to generic competition and market saturation.
- Pricing strategies should account for patent expirations, generics availability, and healthcare policies.
- The overall market remains stable with moderate growth potential, provided resistance and stewardship initiatives do not strongly curtail prescribing.
FAQs
Q1: How does patent expiration impact Cefdinir pricing?
Patent expiration typically leads to a surge in generic availability, causing prices to fall sharply within 1-2 years.
Q2: What are the main competitors to Cefdinir?
Amoxicillin-clavulanate, azithromycin, and cefpodoxime are primary competitors.
Q3: Are there emerging markets for Cefdinir?
Yes, markets such as China, India, and Southeast Asia show increasing demand due to expanding healthcare infrastructure.
Q4: What factors could alter price projections?
Introduction of new formulations, biosimilars, changes in prescribing guidelines, or resistance patterns.
Q5: How does antimicrobial stewardship affect the Cefdinir market?
Stewardship programs aim to reduce inappropriate prescriptions, potentially limiting growth but maintaining market stability.
References
- IQVIA. (2022). Global Pharmaceutical Market Data.
- U.S. Food and Drug Administration. (2015). FDA Approval of Generic Cefdinir.
- Statista. (2022). Antibiotics Market Revenue Worldwide.
- Pfizer. (2022). Cefdinir Product Monograph.
- World Health Organization. (2021). Global Antimicrobial Resistance Surveillance.
