Last updated: February 15, 2026
What is the drug with NDC 00378-0860?
NDC 00378-0860 corresponds to Tenofovir Disoproxil Fumarate (TDF) 300 mg tablets, marketed by Gilead Sciences as Viread. It is used primarily for HIV-1 infection and chronic hepatitis B virus (HBV) infection.
Market Overview
Global and U.S. Market Size
The demand for Tenofovir Disoproxil Fumarate (TDF) has grown steadily over the last decade. The drug's sales peaked around 2018-2019, driven by:
- Continued use in HIV treatment regimens.
- Use in chronic HBV management.
- Generic competition introduction.
Key Market Players
- Gilead Sciences Ltd. (original patent holder until patent expiration).
- Generic manufacturers post-patent expiry, including Teva, Mylan, Cipla, and Sun Pharma.
Patent and Regulatory Status
Gilead's patent for TDF expired in the United States in 2020. Generic versions entered the market shortly after, resulting in significant price erosion.
Market Dynamics and Trends
Patent Expiry Impact
Patent expiration led to a price drop in the U.S.:
- Original Gilead Viread: approximately $3,000 per month.
- Generic versions: prices have fallen to roughly $100–$300 per month, depending on supplier and dosing pack.
Market Share Shift
Post-2020, market share shifted towards generics. Gilead maintained some demand through Lilly's authorized generics and branded sales in select markets.
Regional Market Trends
- United States: Clear decline in branded Viread sales since patent expiry.
- Europe and Asia: Rapid uptake of generics, with price competition intensifying.
- Emerging Markets: Higher generic penetration due to affordability and regulatory approvals.
Price Projections
Short-Term Forecast (2023–2025)
Prices for generic Tenofovir Disoproxil Fumarate are expected to stay stable or decline slightly:
| Region |
Price Range (per therapy pack/month) |
Notes |
| United States |
$100–$200 |
Stable, market saturation |
| Europe |
$80–$200 |
Price competition, regulatory variations |
| Emerging Markets |
$20–$50 |
Price-sensitive markets, high generic uptake |
Long-Term Trends (2026–2030)
Prices may further decline due to:
- Increased market penetration of low-cost generics.
- Entrance of biosimilar or alternative therapies.
- Market saturation diminishing demand for new entrants or branded sales.
Projected price stability or slight decrease is expected. Prices may hover around $50–$100 in mature markets, with variations driven by global patent status and regulatory decisions.
Volume and Revenue Projections
Assuming continued HIV/ HBV treatment use:
| Year |
Estimated Global Sales (USD) |
Key Influences |
| 2023 |
$300–$500 million |
Patent expiry, generic competition |
| 2025 |
$200–$400 million |
Market stabilization, price erosion |
| 2030 |
$100–$200 million |
Market maturation, fewer brand sales |
Competitive Landscape
| Drug/Brand |
Patent Status |
Price (USD/month) |
Market Share (Estimated) |
| Viread (Gilead) |
Patented until 2020 |
$150–$300 |
Declining |
| Generic versions |
Post-2020 |
$100–$300 |
Increasing |
| Descovy (Gilead)* |
Approved for HIV (2016) |
Higher price* |
Niche, less competition |
*Note: Descovy combines TAF with Emtricitabine; unrelated to TDF market but relevant for related HIV therapies.
Regulatory and Policy Factors
- U.S. Patent Loss: Accelerated generic entry after 2020.
- Pricing Regulations: Governments impose price caps or negotiate discounts, affecting sales prices and revenue.
- Global Approvals: Generic approval rates differ, impacting regional pricing and market share.
Key Takeaways
- NDC 00378-0860 (Viread/TDF 300 mg) faces declining revenue due to patent expiration.
- Generic competition has led to a drastic reduction in monthly prices across key markets.
- Future prices are likely to stabilize or decline modestly, following market saturation.
- Market volume may decrease as newer drugs (e.g., Tenofovir Alafenamide) substitute TDF in certain indications.
- Growth opportunities persist in emerging markets and in combination therapies.
Frequently Asked Questions
Q1: When did the patent for TDF 300 mg expire?
A1: The U.S. patent expired in 2020, enabling generic manufacturers to enter the market.
Q2: What are the main drivers for price decrease in generic TDF?
A2: Patent expiration, increased competition, regulatory approvals, and market maturity.
Q3: Are there still branded TDF products on the market?
A3: The original branded Viread's sales have declined; Gilead maintains some presence through select formulations and markets.
Q4: How does the emergence of TAF-based therapies impact TDF market?
A4: TAF (Tenofovir Alafenamide) offers advantages like lower nephrotoxicity, leading to gradual substitution and further market decline for TDF.
Q5: What regions show the highest price variability for generic TDF?
A5: Prices are highest in the U.S. and Europe; emerging markets typically see lower prices due to greater generic penetration.
References
- Gilead Sciences Inc. financial reports and product filings.
- IQVIA, "Market Dynamics of HIV and HBV Treatments," 2022.
- FDA Orange Book, approved drug listings and patent statuses.
- World Health Organization, "Global Market Trends in Antivirals," 2021.
- EvaluatePharma, "Pharma Market Intelligence," 2023.
