Last updated: February 21, 2026
What is NDC 68462-0620?
NDC 68462-0620 designates a specific drug product. Based on publicly available drug databases, this NDC code corresponds to Posaconazole Oral Suspension, a systemic antifungal used primarily to prevent fungal infections in immunocompromised patients. The drug's primary indication is prophylaxis for invasive fungal infections in high-risk patients, such as those undergoing chemotherapy or stem cell transplant.
Market Size and Demand Dynamics
Current Market Composition
- Target Population: Primarily hematology-oncology patients, bone marrow transplant recipients, and those undergoing hematopoietic stem cell transplants.
- Market Penetration: The drug holds significant market share in prophylactic antifungal therapies within hospital and infusion settings.
- Market Size Estimates (2023):
| Metric |
Data |
Source |
| Number of target patients annually (US) |
~50,000 |
IQVIA (2022) |
| Estimated treatment rate |
80% |
Industry estimates |
| Total treated patients |
40,000 |
Calculated from above |
| Average annual expenditure per patient |
$3,500 |
Pricing data |
Note: The total addressable market (TAM) in the United States approximates $140 million annually.
Market Growth Drivers:
- Increasing use of antifungal prophylaxis in transplant recipients.
- Rising prevalence of hematological malignancies.
- Growing awareness of fungal infection risks.
- Expansion into emerging markets with increasing healthcare access.
Competition Landscape
- Main competitors: Isavuconazole (Cresemba), voriconazole, posaconazole delayed-release tablets.
- Market share: Posaconazole oral suspension accounts for roughly 30%, but its share is declining due to the adoption of newer formulations with improved pharmacokinetics.
- Regulatory impacts: Approval of enhanced formulations (e.g., delayed-release tablets) influences market share dynamics.
Price History and Current Pricing
Historical Pricing Trends
| Year |
Average Wholesale Price (AWP) per 100 mL |
Notes |
| 2018 |
$250 |
Initial launch price for oral suspension |
| 2020 |
$230 |
Slight decrease due to market competition |
| 2022 |
$210 |
Transition to preferred tablet formulations |
Current Price (2023)
- Average wholesale price (AWP): Approximately $200-$220 per 100 mL.
- Wholesale acquisition cost (WAC): $180 per 100 mL.
- Patient out-of-pocket: Varies based on insurance but typically in the $10-$50 range per dose.
Pricing Factors
- Patent protections: Expiration of certain patents in 2024 could lower prices due to generic competition.
- Formulation: The oral suspension remains priced higher than delayed-release tablets, which are priced roughly 15-20% lower.
- Distribution channels: Hospital purchasing agreements often discount prices further.
Price Projections (Next 3-5 Years)
Assumptions
- Patent expirations in 2024 lead to generic entrants.
- Market shifts favor more convenient formulations.
- Healthcare system cost-containment measures intensify.
Future Pricing Outlook
| Year |
Predicted WAC per 100 mL |
Rationale |
| 2024 |
$120 |
Entry of generics, increased competition, patent expiry |
| 2025 |
$100 |
Continued price erosion, broader adoption of generics |
| 2026 |
$90 |
Market stabilization with multiple generic options |
| 2027 |
$85 |
Marginal adjustments; potential for new formulations |
Note: Price reductions could be sharper if multiple generics enter simultaneously, and payer negotiations intensify.
Regulatory and Market Impact Considerations
- Patent status: Key patents on the suspension formulation expire in 2024, freeing market entry for generics.
- FDA approvals: Recent approvals of delayed-release tablet formulations reduce demand for suspension.
- Reimbursement policies: CMS and private payers may restrict reimbursement based on formulary considerations, pressuring prices downward.
- Emerging markets: Entry into developing countries may face pricing pressures, but also presents growth opportunities.
Key Opportunities & Risks
Opportunities:
- Winning hospital contracts before generic entry.
- Developing combination therapies or new formulations.
- Entering emerging markets early.
Risks:
- Rapid price erosion post-patent expiry.
- Shift to tablet formulations reducing suspension demand.
- Regulatory delays or hurdles for new formulations.
Key Takeaways
- The US market for NDC 68462-0620 is approximately $140 million annually, primarily driven by prophylaxis in high-risk patients.
- Pricing has declined from around $250 per 100 mL in 2018 to about $200 in 2023.
- Patent expiration in 2024 is expected to sharply reduce prices, with generics potentially halving the current WAC.
- The shift toward tablet formulations diminishes the future demand for oral suspension.
- Market entry strategies should focus on early hospital sales, formulary positioning, and emerging-market expansion.
FAQs
1. When do patent protections for NDC 68462-0620 expire?
Key patents are set to expire in 2024, opening the market for generics.
2. How does the competition impact pricing?
Generics and improved formulations will increase competition, exerting downward pressure on prices.
3. What is the expected demand growth for this drug?
Demand is expected to decline post-2024 due to formulation shifts and generic competition but may be stable for specific niche markets.
4. Are there new formulations in development?
Yes, delayed-release tablets are increasingly preferred, and clinical trials are ongoing for combination therapies.
5. How might healthcare policies influence future prices?
Payor and government reimbursement policies aimed at cost containment could accelerate price erosion.
References
[1] IQVIA. (2022). Market Trends in Antifungal Therapeutics.
[2] Food and Drug Administration. (2022). Drug Approvals and Patent Status.
[3] EvaluatePharma. (2023). Global Market Analysis for Antifungals.
