Last updated: February 27, 2026
What is NDC 62011-0455?
NDC 62011-0455 identifies a specific pharmaceutical product registered for human use. Based on the 11-digit code, the first segment (62011) designates the manufacturer and the second segment (0455) identifies the specific drug and strength.
Note: This NDC corresponds to Fidaxomicin (Dificid), an antibiotic indicated for Clostridioides difficile infections (CDI).
Current Market Landscape
Market Size and Trends
- Fidaxomicin (Dificid) entered the U.S. market in 2011.
- The drug’s sales have grown from approximately $111 million in 2017 to $250 million in 2021.
- Market growth primarily driven by increasing CDI incidence rates, aging population, and a shift toward antibiotic stewardship reducing broad-spectrum antibiotic use.
Approvals and Usage Data
- Indications: Approved for adult CDI treatment in the U.S. and several other markets.
- Prescriptions: Estimated at around 150,000 annually in the U.S. (IQVIA, 2022).
- Competitive landscape:
- Vancomycin and metronidazole remain first-line treatments.
- Fidaxomicin has a higher cost, limiting broad uptake despite evidence of reduced recurrence.
Price Structure and Reimbursement
Wholesale Acquisition Cost (WAC)
- 2023 WAC: Approx. $3,200 per 10-day course.
- Average Sales Price (ASP): Slightly lower than WAC, around $2,850.
Insurance and Medicaid Impact
- Reimbursement rates vary, with Medicaid and Medicare often paying less than list price.
- Out-of-pocket cost for patients can exceed $300–$400 per course after insurance.
Cost Comparison With Similar Drugs
| Drug |
Typical Course Cost |
Indications |
Market Share (2022) |
| Fidaxomicin |
~$3,200 |
CDI, recurrent infections |
10% |
| Vancomycin |
~$60 |
CDI, first-line, generic |
70% |
| Metronidazole |
~$20 |
CDI, first-line, generic |
20% |
Future Price Projections
Factors Influencing Price Trends
- Patent Status: Fidaxomicin’s patent expired in 2024, opening the market to generics.
- Generic Entry: Predicted to reduce prices by approximately 50–70%.
- Biosimilar Competition: Not applicable, as no biosimilar exists for fidaxomicin.
- Market Penetration: Expected increase in generic use could lead to a price decrease over the next 12–24 months.
Estimated Price Trajectory
| Year |
Expected Price Range |
Notes |
| 2023 |
~$3,200 (brand); <$1,500 (generic) |
Entry of generics begins 2024 |
| 2024 |
~$2,000–$2,500 (generics) |
Market stabilization and increased competition |
| 2025 |
~$1,200–$1,500 |
Continued price decline, increased uptake of generics |
Market Dynamics & Impacts
- Manufacturers may reduce list prices initially to maintain market share.
- Insurance negotiations could influence actual prices paid.
- Payor incentives may favor combination or alternative therapies.
Strategic Considerations for Stakeholders
- Pharmaceutical Companies: Focus on patent enforcement, biosimilar development, and market entry strategies.
- Healthcare Providers: Assess cost-benefit profiles and patient outcomes to optimize therapy choices.
- Investors: Monitor patent expiry dates, generic approval timelines, and reimbursement policies to forecast sales and valuation shifts.
Key Takeaways
- Fidaxomicin (NDC 62011-0455) has experienced steady growth in managing CDI but faces significant generic price erosion post-patent expiration.
- The current list price averages around $3,200 per course; prices are expected to decline substantially in 2024 and beyond.
- An increase in generic availability will likely result in prices below $1,500, affecting profit margins and market share.
- Reimbursement structures and insurance coverage will influence actual costs for payers and patients.
- Competitive positioning will depend heavily on how quickly generics penetrate the market and on strategic pricing.
FAQs
1. When do generics for fidaxomicin become available?
Expected approval in late 2024, approximately 18 months after patent expiration.
2. How does the price of fidaxomicin compare to vancomycin?
Fidaxomicin costs roughly 50–60 times more per treatment course than generic vancomycin.
3. Will prices ever return to pre-patent levels?
No. Prices are expected to stabilize at lower levels due to increased competition and market pressure.
4. What factors could slow down generic adoption?
Regulatory delays or patent disputes could temporarily slow generic market entry.
5. What are key opportunities for investors post-patent expiry?
Investing in generic manufacturers or contract manufacturing organizations specializing in antibiotic production.
References
[1] IQVIA. (2022). U.S. prescription drug data.
[2] U.S. Food and Drug Administration. (2024). Patent and exclusivity data for fidaxomicin.
