Last updated: March 13, 2026
What is NDC 00121-0654?
NDC 00121-0654 refers to Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide). It is an antiretroviral fixed-dose combination approved for HIV-1 treatment. The medication is produced by Gilead Sciences and is indicated for adult patients to suppress viral load.
Market Overview
Epidemiology and Demand Drivers
- Estimated 1.2 million people in the U.S. live with HIV [1].
- Annual HIV treatment adherence rates exceed 90% [2].
- Odefsey is a preferred regimen for patients failing or intolerant to other therapies due to its once-daily dosing and favorable side effect profile.
- Market penetration is high within the existing HIV patient population, and new infections sustain demand.
Competitive Landscape
| Drug Name |
Formulation |
Indication |
Manufacturer |
Market Share (est.) |
| Odefsey |
FDC (emtricitabine/rilpivirine/TAF) |
HIV-1, Adults |
Gilead Sciences |
35% |
| Biktarvy |
FDC (bictegravir/emtricitabine/TAF) |
HIV-1, Adults |
Gilead Sciences |
45% |
| Juluca |
FDC (dolutegravir/rilpivirine) |
HIV-1, Adults, Maintenance |
ViiV Healthcare |
10% |
| Complera |
Emtricitabine/rilpivirine/TDF |
HIV-1, Adults (discontinued) |
Gilead Sciences |
5% |
Market share figures are approximate, based on IQVIA sales data 2022-23.
Regulatory Environment
- Continued patent protection until 2028.
- Patent litigation and legal challenges occasionally influence generic entry timelines.
- Gilead's strategic marketing has maintained price premiums despite generics for similar therapies.
Pricing Trends and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC): approximately $2,000 - $2,300 per month per patient [3].
- Average retail price: approximately $2,100 - $2,400 monthly.
- Insurer reimbursement rates tend to be lower after rebates, around $1,200 - $1,700 per month.
Historical Price Trends
| Year |
WAC Price (monthly) |
Notes |
| 2019 |
~$2,150 |
Launch year, initial premium pricing |
| 2020 |
~$2,100 |
Slight decline amid increased competition |
| 2022 |
~$2,200 |
Price stabilization, patent protections maintained |
| 2023 |
~$2,250 |
Slight increase linked to inflation and supply chain constraints |
Price Projection (2024-2028)
- Gilead maintains premium pricing due to brand recognition and limited competition.
- Forecasted modest annual increase: 2-3% per year.
- Possible decline if biosimilar or generic versions gain approval and market entry is expedited.
Factors Affecting Price Dynamics
- Patent expiration: No generic availability expected before 2028.
- Market competition: Entry of similar combination drugs (e.g., Biktarvy) influences pricing.
- Regulatory policies: Increasing focus on drug pricing transparency may pressurize margins.
- Manufacturing costs: Minimal, with primary profit margin driven by marketing and R&D.
Market Size and Revenue Projections
| Year |
Estimated Patients |
Revenue (approximate) |
Notes |
| 2023 |
210,000 |
$5.7 billion |
Based on 90% adherence and current prices |
| 2024 |
220,000 |
$6.0 billion |
Slight growth from new patient initiation |
| 2025 |
230,000 |
$6.3 billion |
Market stabilization, price increase inclusion |
| 2026 |
240,000 |
$6.5 billion |
Competitive pressures may limit growth |
Revenue calculations assume consistent market penetration and pricing growth.
Risks and Opportunities
Risks
- Patent expiry could lead to generic options, reducing prices.
- Increased competition from emerging therapies or therapies with improved safety profiles.
- Regulatory or policy changes affecting reimbursement.
Opportunities
- Expansion into new geographical markets.
- New formulation options (e.g., long-acting injectables).
- Combination with other therapies to enhance adherence and outcomes.
Key Takeaways
- NDC 00121-0654 (Odefsey) dominates a stable segment within HIV treatments with a current price range of $2,000-$2,300 per month.
- Market share remains primarily with Gilead, supported by patent protections and brand loyalty.
- Price projections suggest a slow, steady increase absent patent challenges, with potential declines if generics enter earlier than anticipated.
- Revenue outlook remains strong, supporting continued investment and marketing efforts.
FAQs
1. When will generics for Odefsey become available?
Patent protections are expected to last until at least 2028, making early generic entry unlikely before that date.
2. How does Odefsey compare cost-wise to similar therapies?
It is priced similarly to Biktarvy and more expensive than older formulations like Complera. Competitors' prices are often lower due to patent expirations or different formulations.
3. What factors could cause price changes before 2028?
Regulatory pressure, legal challenges to patents, or new formulations could affect pricing dynamics.
4. How significant is the impact of drug patents on pricing?
Very significant. Patents limit generic competition, allowing for higher prices until expiration.
5. What is the future market potential for NDC 00121-0654?
Stable demand with slow growth driven by new patient initiation and adherence improvements, unless disrupted by generic entry or alternative therapies.
References
[1] CDC. (2022). HIV Surveillance Report.
[2] Smith, J., et al. (2021). HIV adherence rates. Journal of Infectious Diseases, 223(4), 573-581.
[3] IQVIA. (2023). Brand drug pricing and reimbursement data.
