Last updated: February 24, 2026
What is NDC 31722-0120?
NDC 31722-0120 is the code assigned to a specific drug product approved by the FDA. This NDC refers to Fuzeon (enfuvirtide) 90 mg/vial, used in HIV/AIDS treatment. It is manufactured by Hoffmann-La Roche. The drug is available as a subcutaneous injection for highly active antiretroviral therapy (HAART).
Market Size and Demand Dynamics
Current Market Landscape
- Patient Population: Approximately 1.2 million Americans currently living with HIV/AIDS, with roughly 80% on antiretroviral therapy (ART), as of 2021.
- Fuzeon Usage: Primarily reserved for treatment-experienced patients with multi-drug resistant HIV or those intolerant to other therapies.
- Market Penetration: Estimated to represent 3-5% of total HIV/AIDS drug therapy, due to its specific use case.
Competition and Alternatives
- First-line therapies: Integrase inhibitors like Dolutegravir and Bictegravir dominate, with broader tolerability and ease of administration.
- Other fusion inhibitors: Fostemsavir (Rukobia) can serve as an alternative in resistant cases; currently limited by approval scope.
- Pricing influence: The niche positioning constrains competitive pressure, but new agents may impact future demand.
Historical Sales Data
- 2020: Approximate sales of $130 million in the U.S. (IQVIA).
- 2021: Slight decline by 2-3% attributable to increased use of oral therapies.
- 2022: Continued stabilization, sales around $125 million, reflecting steady demand with limited growth potential.
Price Trends and Projections
Current Pricing Metrics
- Average Wholesale Price (AWP): Approximately $1,200 per 90 mg vial, as of Q4 2022 [2].
- Reimbursement: Commercial insurers and Medicaid programs vary, with negotiated discounts reducing the net price.
Cost Factors
- Manufacturing: Biologic and peptide-based injectables often face high production costs, contributing to stable pricing.
- Market Competition: Limited competitors sustain pricing authority; however, patent expirations or new entries could pressure prices.
Price Projection Analysis (Next 5 Years)
| Year |
Estimated AWP per Vial |
Rationale |
| 2023 |
$1,200 |
Current levels, slight inflation adjusted for raw material costs. |
| 2024 |
$1,220 |
Minimal inflation, no significant competition, supply chain stability. |
| 2025 |
$1,240 |
Potential for slight price increase if demand persists, or slight discounts if new competitors emerge. |
| 2026 |
$1,250 |
Unknown if biosimilar or alternative therapies gain approval and market share. |
| 2027 |
$1,260 |
Stable pricing expected unless patent expiration or new competition occurs. |
Assumptions and Risks
- Patent expiry unlikely within five years, preserving current pricing power.
- Introduction of biosimilars or new fusion inhibitors, possibly arriving after 2027, could disrupt market share.
- Changes in insurance reimbursement policies may influence net prices.
Regulatory and Reimbursement Environment
- FDA Status: Approved since 2003, patent protection extends into next decade.
- Pricing regulation: There is no specific government control on drug prices in the U.S., but payer negotiations influence net revenue.
- Reimbursement Trends: Shift towards value-based reimbursement may impact profitability.
Key Takeaways
- NDC 31722-0120 (Fuzeon) maintains a niche market for heavily treatment-experienced HIV patients.
- Sales have stabilized around $125-130 million annually, with limited growth prospects.
- Pricing remains steady, with current AWP near $1,200 per vial, supported by limited competition.
- Future pricing depends on patent protections, emergence of biosimilars, and regulatory changes.
- Demand remains resilient among specific patient populations, despite competition from oral agents.
FAQs
1. How does the price of NDC 31722-0120 compare to other HIV drugs?
Fuzeon’s AWP is higher than oral antiretrovirals like Dolutegravir (AWP approximately $50–$100 per pill), but comparable or slightly higher than other injectable therapies targeting resistant HIV (e.g., ibalizumab).
2. What factors could lead to price reductions?
Introduction of biosimilars, patent expiration, or significant policy shifts could pressure prices.
3. How do payer negotiations affect net revenue?
Insurance companies and Medicaid commonly negotiate discounts, reducing the effective price received from the wholesale list price.
4. Is there potential for increased demand?
Demand growth is limited; the drug serves a small, specific subset of treatment-experienced patients.
5. What regulatory changes could impact this market?
FDA approval of new, more convenient biologics or combination therapies could diminish demand for Fuzeon.
References
[1] CDC. (2021). HIV in the United States.
[2] IQVIA. (2022). National Sales Data for HIV/AIDS Drugs.
[3] FDA. (2003). Fuzeon (enfuvirtide) approval announcement.
