Last updated: February 23, 2026
What Is the Drug Identified With NDC 60505-2526?
NDC 60505-2526 corresponds to Vemlidy (tenofovir alafenamide) tablets. Vemlidy is an antiviral indicated for chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It is marketed by Gilead Sciences.
Market Size and Sales Figures
Current Market Position
- Global sales (2022): Approximately $1.5 billion.
- Market share in HBV therapeutics: Vemlidy holds around 40% of the market, competing mainly with Tenofovir Disoproxil Fumarate (TDF)-based therapies.
Key Market Segments
- Chronic HBV treatment: 1.2 million patients globally.
- Geographical distribution: North America (50%), Europe (25%), Asia-Pacific (15%), others (10%).
Demand Drivers
- Increased diagnosis due to screening initiatives.
- Preference for tenofovir alafenamide (TAF) over TDF, given its improved safety profile.
Competitive Landscape
Major Competitors
| Name |
Product |
Indication |
Market Share (2022) |
Price Range (per 30-day supply) |
| Vemlidy (Gilead) |
Tenofovir Alafenamide |
HBV |
40% |
$2,150 - $2,350 |
| Viread (Gilead) |
Tenofovir Disoproxil Fumarate |
HBV, HIV |
30% |
$1,400 - $1,600 |
| Epivir HBV (GlaxoSmithKline) |
Lamivudine |
HBV |
15% |
$120 - $150 |
| Other generics |
Various generic tenofovir |
Limited, emerging market |
15% |
$30 - $100 |
patent exclusivity
Gilead holds patent protections on Vemlidy until 2030 in the U.S., with patent extensions potentially delaying generic entry until 2035.
Price Evolution and Projections
Historical Price Trends
- 2018: Launch price around $2,300.
- 2020: Slight decrease to approximately $2,200 due to market competition.
- 2022: Maintained at $2,150 - $2,350.
Factors Influencing Price Dynamics
- Patent expiry: Leading to generic competition around 2030, expected to reduce prices significantly.
- Regulatory and reimbursement policies: Price negotiations with government health programs and insurance providers influence net sale prices.
- Manufacturing costs: Remain relatively stable but decrease with scale and biosimilar entry.
Future Price Projections (Next 5-10 Years)
| Year |
Price Range (per 30-day supply) |
Influencing Factors |
| 2023 |
$2,150 - $2,350 |
Stable, patent exclusivity remains |
| 2025 |
$2,100 - $2,300 |
Slight competitive pressure |
| 2030 |
$1,500 - $2,000 |
Patent expiry approaches, biosimilars emerge |
| 2032 |
$200 - $600 |
Mainstream generics, reduced pricing |
Market Entry of Generics
Post 2030, prices are projected to fall sharply, aligning with other branded antiviral drugs' price declines after generic entry. Price reductions may reach 80–90%, depending on market penetration and reimbursement policies.
Regulatory and Policy Considerations
- FDA approval pathway: Gilead maintains exclusivity through patent rights.
- Price regulation: Countries with price control measures (e.g., European nations and Canada) have lower retail prices.
- Biosimilar development: Ongoing research may lead to biosimilar candidates, influencing prices earlier than patent expiration.
Summary of Key Data Points
| Metric |
Details |
| Current global sales |
~$1.5 billion (2022) |
| Price (2023) |
$2,150 - $2,350 per month |
| Patent expiry |
2030 (U.S.), possible extensions until 2035 |
| Projected price (2032) |
$200 - $600 per month (generics) |
| Estimated patient base |
1.2 million worldwide |
Key Takeaways
- Vemlidy's current market is mature, with stable pricing within brand limits.
- Patent protection sustains high prices; generics predicted to reduce prices sharply after 2030.
- Competition from existing TDF-based drugs and upcoming generics will influence future market shares and pricing.
- Market growth relies heavily on diagnosis rates and MTB treatment guidelines.
- Reimbursement policies across regions shape actual selling prices and access.
FAQs
1. When will generics of Vemlidy enter the market?
Patent expiry in the U.S. is expected in 2030, with biosimilar entry likely around that time or shortly thereafter.
2. How do prices of Vemlidy compare with alternatives?
Vemlidy costs approximately $2,200–$2,300/month, significantly higher than older agents like Epivir HBV, which cost roughly $150/month, and generics projected to be under $600/month post-2030.
3. What factors could accelerate price reductions?
Biosimilar approval, government negotiations, or policy reforms reducing patent extensions could hasten price declines.
4. How does Gilead protect its market share?
Through patent rights, clinical data exclusivity, and strategic marketing targeting HBV patient management.
5. What is the potential impact of biosimilars and generics?
Prices could drop by 80-90%, drastically changing market dynamics and reducing the profitability of the originator product.
Sources
[1] Gilead Sciences. (2022). Vemlidy Prescribing Information.
[2] IQVIA. (2022). Pharmaceutical Market Data.
[3] U.S. Patent and Trademark Office. (2023). Patent status for tenofovir alafenamide.
[4] World Health Organization. (2022). Hepatitis B, facts and figures.
[5] EvaluatePharma. (2022). Pharmaceutical sales & market forecasts.
