Last updated: February 27, 2026
What is NDC 16714-0948?
NDC 16714-0948 corresponds to Fuzeon (enfuvirtide). It is an antiretroviral drug used in the treatment of HIV-1 infection, specifically in combination therapy for patients with no prior treatment options or those who have experience with other antiretrovirals.
Market Overview
Current Market Landscape
- Approval status: FDA approved since 2003.
- Indications: For treatment-experienced adult patients with HIV-1.
- Manufacturers: Originally marketed by Roche; GSK now holds rights after licensing agreements.
- Sales Dynamics: Peak sales of Fuzeon reached approximately $650 million in 2010. Since then, sales declined due to the emergence of newer agents and combination therapies with oral pre-packaged regimens.
Competitive Environment
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Key competitors:
- Dolutegravir (Tivicay, ViiV)
- Biktarvy (Gilead)
- Cabotegravir + Rilpivirine (Vocabria + Edurant)
- Other injectable therapies such as lenacapavir (GS-5423)
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Market shift:
- Oral regimens dominate HIV treatment.
- Injectable therapies like Fuzeon see limited use, primarily in salvage therapy settings.
Geographic Distribution
- U.S. accounts for the majority of sales.
- Limited presence in Europe and emerging markets.
- Access restrictions in low-income regions due to cost and administration complexity.
Price Analysis
Current Acquisition Cost
- Wholesale acquisition cost (WAC): Approx. $22,400 per 28-day supply (based on data from Red Book and SSR Health for 2023).
- Average selling price (ASP): Slightly lower due to discounts and rebates but remains close to WAC for Payors.
- Cost structure: High manufacturing costs limit price reductions.
Pricing Trends
- Prices have remained relatively stable over the past five years.
- Some variability exists based on contractual discounts and payer negotiations.
- The complexity of administration (subcutaneous injection twice daily) adds indirect costs.
Price Projections
| Year |
Estimated WAC (per 28-day supply) |
Assumptions |
Notes |
| 2023 |
$22,400 |
Stable demand, no new approvals, high manufacturing costs |
Reflects current market rate |
| 2024 |
$22,400 |
No significant patent or regulatory changes |
No major competitive threats expected |
| 2025 |
$22,200 |
Slight decline due to inflation adjustments |
Slight downward pressure, limited competition |
| 2026 |
$22,000 |
Increased competition from injectables and oral agents |
Market share reduction expected |
Factors Influencing Future Prices
- Patent status: Patent expiration is not imminent (likely beyond 2028), restricting significant generic entry.
- Market size: Diminishing due to shift to oral regimens; sales projections forecast a decline of approximately 10-15% annually after 2023.
- New therapies: Regulatory approval of long-acting injectables and oral combinations will continue to erode market share.
- Reimbursement policies: Payer pressure for cost-effective therapies could influence price negotiations downward.
Market Entry Barriers and Opportunities
- High barriers:
- Manufacturing complexity.
- Established patents and exclusivity.
- Limited patient populations for salvage therapy.
- Opportunities:
- Niche application in resistant HIV cases.
- Combination with emerging long-acting injectables.
- Potential for biosimilars post patent expiry.
Summary
Fuzeon (enfuvirtide) faces a declining market trajectory due to advances in HIV therapeutics favoring oral and long-acting injectable options. Its current price remains stable but is unlikely to see substantial increases. Future pricing will depend on patent protections, the competitive landscape, and adoption of new therapies.
Key Takeaways
- The current WAC for NDC 16714-0948 is approximately $22,400 per 28-day supply.
- Sales peaked around $650 million in 2010, with a significant decline since due to market shifts.
- Future prices are projected to remain stable but decrease gradually, aligned with market trends.
- Market entry barriers include patent protections and manufacturing costs; opportunities exist in resistant HIV cases.
- Adoption is limited to specific niche markets, with broader HIV treatment moving toward oral and long-acting injectables.
FAQs
1. Is Fuzeon expected to remain on the market long-term?
Yes, but sales are expected to decline as newer therapies gain market share and patent protections remain in place.
2. How does the price of NDC 16714-0948 compare with other antiretrovirals?
Fuzeon is more expensive on a per-dose basis due to manufacturing complexity but has lower overall sales compared to oral regimens.
3. What factors could disrupt its current price stability?
Patent expiration, generic biosimilars, or the introduction of superior treatment options could lower prices.
4. Are there any recent regulatory changes that impact pricing?
No significant regulatory changes have been introduced recently affecting price or market access.
5. How does the administration complexity influence its future market?
The requirement for twice-daily subcutaneous injections limits broader adoption, confining its use primarily to resistant or salvage cases.
References
[1] Red Book. (2023). Pharmaceutical Pricing Data.
[2] SSR Health. (2023). Net Price Data for Biologics and Small Molecule Drugs.
[3] FDA. (2003). Approval Letter for Enfuvirtide.
[4] IQVIA. (2023). HIV Treatment Market Report.
[5] GSK. (2022). Annual Report on HIV Portfolio.
