Last updated: March 8, 2026
What is NDC 00310-0274?
NDC 00310-0274 corresponds to Fuzeon (enfuvirtide) 100 mg powder for solution for injection. Fuzeon is an antiretroviral drug used as part of HIV-1 treatment regimens for patients with treatment-experienced HIV infection.
Market Overview
Market Size and Growth
The global HIV therapy market was valued at approximately $26 billion in 2022 and is projected to reach $36 billion by 2027, expanding at a CAGR of 6.8% (Evaluate Pharma, 2022). Fuzeon's market segment constitutes a niche within this larger field, focusing on treatment-resistant HIV strains.
Key Competitors
- Insurers and payers increasingly favor oral antiretrovirals, reducing the use of injectable options.
- Other injectable drugs like cabotegravir and rilpivirine (cabotegravir LA, sold as Apretude) are gaining market share due to ease of administration.
- Pricing shifts favor newer drugs with longer dosing intervals.
Market Dynamics
- Patient Population: A smaller segment of HIV-infected patients, specifically those with resistance or intolerance to other therapies, continues to rely on enfuvirtide.
- Administration Mode: Injectable form limits adoption versus oral therapies.
- Reimbursement: Coverage varies by country and payer policies, impacting utilization rates.
Price Structure and Projections
Current Pricing
- List Price: Approximately $20,000 to $25,000 per 30-day supply (unit dose: 100 mg twice daily). This is consistent with wholesale acquisition cost (WAC) figures.
Reimbursement & Actual Costs
- Average transaction prices are roughly 20-25% lower than list prices after negotiations.
- Patient access programs reduce out-of-pocket costs for eligible patients.
Price Trends
| Year |
Price Range (per 30-day supply) |
Notes |
| 2020 |
$20,000 – $25,000 |
List prices stable with minor fluctuations. |
| 2022 |
$19,500 – $24,500 |
Slight price reductions due to payer negotiations. |
| 2023 |
$19,000 – $24,000 |
Continued pressure from market competition. |
| 2024+ |
$18,500 – $23,500 |
Expected downward trend driven by newer therapies and biosimilar interest. |
Future Price Projections
- Moderate decline expected: 1-2% annual decrease over the next five years due to increased competition and market consolidation.
- Impact of biosimilars or generics: Currently unavailable for enfuvirtide, but potential market entry could accelerate price declines once biosimilar pathways are established.
Considerations Affecting Pricing
- Patent or exclusivity status: No recent patents filed since 2015; exclusivity expiration may enable biosimilar development.
- Market penetration of alternative drugs: Growing use of long-acting injectables such as cabotegravir.
Market Access and Adoption Factors
- Clinical guidelines:** Reserve enfuvirtide for salvage therapy scenarios; widespread preference shifts to oral or long-acting injectable regimens.
- Patient preference: Injectable administration diminishes appeal versus oral options.
- Pricing strategies: Manufacturers may offer discounts or patient assistance to maintain market share.
Summary
- The drug maintains a niche market primarily for treatment-resistant HIV cases.
- Pricing remains high but has slightly declined due to competitive pressures.
- Market adoption faces headwinds from newer, more convenient therapies.
- Price projections suggest continued gradual reductions, especially if biosimilars or generics enter the market.
Key Takeaways
- NDC 00310-0274 (Fuzeon) is a niche product with a price around $19,000–$24,000 per month.
- The market is shrinking as oral and long-acting alternatives grow in popularity.
- Future prices are likely to decline modestly, driven by increased competition and patent expiration.
- Payers' negotiation power influences actual transaction prices downward from list prices.
- Market growth is limited, with stable or contracting revenue prospects.
FAQs
1. How does the price of enfuvirtide compare to newer HIV therapies?
Newer oral and long-acting injectables often cost less per dose, or at least are more convenient, making enfuvirtide less attractive despite comparable costs.
2. Are biosimilars likely for enfuvirtide?
Biosimilar development depends on patent status. As of now, no biosimilars exist; patent expiration could enable entry, potentially reducing prices.
3. How significant is reimbursement for enfuvirtide?
Reimbursement varies; insurance coverage is generally available but often involves negotiation, copays, or patient assistance programs.
4. Will prices continue to decline?
Yes, moderate declines (~1-2% annually) are expected over the next five years owing to market competition.
5. What factors could accelerate price reductions?
Entry of biosimilars, shifts in clinical guidelines favoring alternative therapies, and policy changes promoting low-cost options could speed price declines.
Citations
- Evaluate Pharma. (2022). Market forecasts for HIV therapies.
- Centers for Disease Control and Prevention. (2021). HIV Surveillance Report.
- Medicare & Medicaid Services. (2022). Reimbursement policies for injectable HIV therapies.
- IQVIA. (2022). Pharmaceutical Pricing Trends.
- FDA. (2020). Biosimilar Development and Approvals.
