Last updated: March 30, 2026
What is NDC 00406-8891?
NDC 00406-8891 refers to a specific drug product, identified by the National Drug Code (NDC). The NDC is a unique, 11-digit, three-segment number assigned to drugs marketed in the United States. As of the latest data, NDC 00406-8891 corresponds to Emtricitabine and Tenofovir Disoproxil Fumarate tablets.
Market Overview
Drug Class and Indications
Emtricitabine and Tenofovir Disoproxil Fumarate are antiretroviral agents used primarily in the treatment of HIV-1 infection. They are often combined in fixed-dose formulations.
Market Size and Trends
- The global HIV drug market surpassed $21 billion in 2022.
- The U.S. accounts for approximately 45% of the global market.
- Fixed-dose combination therapies constitute over 80% of HIV treatments in the U.S.
Key Competitors
Major competitors include:
- Gilead Sciences’ Truvada and Descovy (emtricitabine-tenofovir formulations).
- Biotech firms developing novel antiretrovirals or long-acting formulations.
Market Drivers
- Rising HIV prevalence: approximately 1.2 million cases in the U.S.
- Increased screening and diagnosis.
- Improved adherence with fixed-dose combinations.
Regulatory Status
- NDC 00406-8891 is approved by the FDA.
- It falls under patent protections until approximately 2028.
- Generic versions entered the market post-patent expiration.
Price Stability and Trends
Historical Pricing
- Brand-name Emtricitabine/Tenofovir Disoproxil Fumarate (e.g., Truvada) averaged $1,800 per month in 2018.
- Generic versions reduced prices to approximately $700–$900 per month by 2022.
Current Pricing Dynamics
| Year |
Brand Price |
Generic Price |
Price Change (YoY) |
| 2018 |
$1,800 |
N/A |
N/A |
| 2020 |
$1,600 |
$850 |
-11% / -2% |
| 2022 |
$1,500 |
$800 |
-6% / -6% |
Projected Price Trends
- Short-term (1-3 years): Continuation of price stabilization, with potential slight reductions due to market competition.
- Long-term (3-5 years): Prices could decline further as patents expire and more generics enter the market, potentially reaching $500–$700 per month.
Market Entry and Pricing Strategies for New Entrants
- Entry is feasible post-patent expiration (~2028).
- Pricing strategies depend on patents, manufacturing costs, and competition.
- Biosimilar and generic manufacturers could price 20-40% below current branded prices.
Regulatory and Policy Influences
- Medicaid and Medicare Part D negotiation power influences prices.
- FDA approval for biosimilars and generics exerts downward pressure.
- Legislation promoting drug price transparency might impact pricing strategies.
Revenue Projections
Given the current market size and trends:
- Estimated annual sales for this combination are approximately $4–5 billion in the U.S.
- With generics gaining market share post-patent loss, sales could decline or shift to lower-cost formulations.
Summary of Price Forecasts (Next 3 Years)
| Year |
Estimated Price Range (per month) |
Notes |
| 2023 |
$1,500–$1,700 |
Stable, with slight decline |
| 2024 |
$1,400–$1,600 |
Mild competitive pressure |
| 2025 |
$1,300–$1,500 |
Increased generic uptake |
Key Takeaways
- NDC 00406-8891 corresponds to a widely used HIV treatment tablet.
- The market is mature, with prices stabilized by generic competition.
- Prices are expected to decline over the next five years as patent protections expire and generics penetrate the market.
- Entry barriers for new competitors remain until patent expiry, but post-expiry prices will likely fall further.
- Market size within the U.S. remains significant due to the high prevalence of HIV and reliance on combination therapies.
FAQs
Q1: When will NDC 00406-8891 face patent expiration?
A1: Patent protections are set to expire around 2028.
Q2: How does generic entry impact pricing?
A2: Generics generally reduce per-unit prices by 20-40%, leading to overall therapy cost reductions.
Q3: Are new formulations (e.g., long-acting injectables) affecting this market?
A3: Yes, the introduction of long-acting injectables is shifting some market share away from oral tablets.
Q4: What policies could influence future prices?
A4: Price transparency legislation, Medicaid negotiations, and biosimilar policies will impact pricing dynamics.
Q5: How significant is the U.S. market compared to the global?
A5: The U.S. accounts for approximately 45-50% of the global HIV drug market.
References
[1] IQVIA. (2022). HIV market overview.
[2] FDA. (2022). Drug Approvals and Patent Data.
[3] Centers for Disease Control and Prevention (CDC). (2022). HIV Surveillance Report.
[4] Statista. (2022). Global HIV drug market.
