Last updated: March 18, 2026
What is NDC 00527-3288?
NDC 00527-3288 corresponds to Fuzeon (enfuvirtide), an antiretroviral used for HIV-1 treatment in patients with multi-drug resistant HIV. Approved by the FDA in 2003, it is administered via subcutaneous injection.
Current Market Landscape
Market Size and Usage
- Total HIV patients on antiretroviral therapy (ART) in the U.S.: approximately 1.2 million (CDC, 2022).
- Patients with multi-drug resistant HIV: estimated at 10-15%, representing 120,000–180,000 individuals.
- Fuzeon's patient share: estimates suggest around 10-15%, noting declining use due to newer agents.
Competitive Environment
- Existing alternatives: newer injectable agents such as cabotegravir and rilpivirine (both long-acting injectables) have begun replacing enfuvirtide.
- Market share erosion: since the FDA approval of these agents in 2018 and 2021, Fuzeon’s market share declined by approximately 70%.
- Healthcare provider adoption: limited to specialized cases due to administration complexity and side effect profile.
Regulatory and Patent Status
- Patent expiration: Fuzeon’s original patent expired in 2018; no current exclusivity protections exist.
- Generic presence: generic formulations entered the market post-expiry, increasing competition and reducing prices.
Price Dynamics
Historical Price Points
- 2010: Average wholesale price (AWP) ranged from $20,000–$25,000 per patient per year.
- 2018: Price peaked at approximately $20,500, with some commercial discounts.
- Post-2018: prices declined owing to generics and market competition, now averaging around $10,000–$12,000.
Current Pricing Factors
- List Price: $12,000–$15,000 per year, varying by distributor and payor negotiations.
- Reimbursement: Medicaid and commercial insurers typically negotiate discounts, leading to net prices of $8,000–$10,000.
- Patient access programs: manufacturer offers assistance, effectively reducing out-of-pocket costs.
Future Price Projections
Projection Assumptions
- Market share: expected further decline as long-acting injectables replace enfuvirtide.
- Pricing: continued downward pressure from generic competition and price sensitivity.
- Regulatory factors: no new patent protections or exclusivity extensions anticipated.
Price Trajectory (2023–2028)
| Year |
Predicted List Price |
Expected Net Price* |
Market Share |
Notes |
| 2023 |
$10,000 |
$6,000–$8,000 |
5–8% |
Dominance of generics; use limited to existing patients |
| 2024 |
$9,500 |
$5,500–$7,500 |
3–5% |
Slight decrease in utilization |
| 2025 |
$9,000 |
$5,000–$7,000 |
2–4% |
Transition further to newer therapies |
| 2026 |
$8,500 |
$4,500–$6,500 |
1–3% |
Near-obsolescence as injectable alternatives expand |
| 2027 |
$8,000 |
$4,000–$6,000 |
<1% |
Minimal use, primarily legacy cases |
| 2028 |
$7,500 |
$3,500–$5,500 |
<1% |
Expected near-market withdrawal |
*Net price reflects typical payer discounts and Patient Assistance Programs.
Market Drivers and Risks
- Drivers: advances in long-acting injectables, expanded use in resistant HIV cases, cost-containment pressures.
- Risks: further declines in use, patent challenges, evolving treatment guidelines favoring newer agents.
Key Takeaways
- Fuzeon primarily serves a niche in resistant HIV cases, with decreasing market share.
- Price has decreased from ~$20,000 before generic competition to below $10,000.
- Projected prices continue declining, with minimal use expected beyond 2025.
- Long-term value diminishes as newer therapies dominate treatment algorithms.
- Overall market size will shrink to a small subset of resistant HIV patients.
FAQs
Q1: What factors influence Fuzeon’s price stability today?
A1: Generic competition, market share decline, and reimbursement negotiations primarily drive price decreases.
Q2: Will Fuzeon regain market share with new formulations?
A2: Unlikely; current trends favor long-acting injectables with better tolerability and convenience.
Q3: How does patent expiration impact pricing?
A3: It enables generic manufacturing, significantly lowering prices and reducing profits for brand equivalents.
Q4: What are the primary barriers to Fuzeon’s further use?
A4: Administration complexity, side effect profile, availability of superior alternatives.
Q5: Is Fuzeon still a viable investment?
A5: Market decline and low future sales prospects suggest limited attractiveness; focus on legacy use.
References
[1] Centers for Disease Control and Prevention (CDC). (2022). HIV Surveillance Report.
[2] FDA. (2003). Fuzeon (enfuvirtide) approval announcement.
[3] IMS Health. (2020). Pharmaceutical Market Dynamics.
[4] Healthcare Financial Management Association. (2021). HIV treatment landscape.
