Last updated: February 15, 2026
What Is the Drug Corresponding to NDC 51672-2020?
NDC 51672-2020 corresponds to Vemlidy (tenofovir alafenamide), marketed by Gilead Sciences. It is approved for the treatment of chronic hepatitis B virus (HBV) infection. The drug is a prodrug that delivers tenofovir, an antiretroviral agent with high potency and improved safety profile compared to tenofovir disoproxil fumarate.
Market Overview
Market Size and Key Drivers
The global hepatitis B treatment market was valued at approximately $2.2 billion in 2020. It is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2027, driven by increasing screening efforts, aging populations, and the prevalence of HBV infections.
Prevalence and Demand Trends
- Estimated 296 million globally infected with HBV [1].
- Asia-Pacific accounts for over 60% of cases, with China alone comprising approximately 70 million carriers.
- The U.S. has a lower overall prevalence but a significant number of chronic cases, around 1.2 million.
Competitive Landscape
Major competitors include:
- Tenofovir disoproxil fumarate (TDF) (Viread, Vosevi)
- Entecavir (Baraclude)
- Pegylated interferon alfa
Vemlidy’s differentiated safety profile and approval for specific patient populations give it an edge. However, TDF remains the most prescribed due to lower cost and familiarity.
Price Trends and Projections
Current Pricing Status
- In the U.S., the wholesale acquisition cost (WAC) for a 25 mg Vemlidy tablet is approximately $3,500 per month (around $42,000 annually) [2].
- Generic versions are not yet available, limiting price erosion.
Historical Price Changes
Since launch in 2019, Vemlidy’s price has remained stable. Gilead has maintained premium pricing due to its safety advantages and patent protections.
Price Projections (2023–2027)
| Year |
Estimated Price (per month) |
Notes |
| 2023 |
$3,500 |
Current stabilized price |
| 2024 |
$3,400–$3,600 |
Slight decline expected due to patent expiry risks |
| 2025 |
$3,200–$3,500 |
Patent challenges may yield generic entry in some markets |
| 2026 |
$2,500–$3,000 |
Entry of generics in select geographies |
| 2027 |
$2,000–$2,800 |
Widespread generic availability possible |
Influencing Factors
-
Patent Status: Patents for Vemlidy are scheduled to expire around 2025–2026 in major markets, opening pathways for generics, which could reduce prices by up to 50–70% [3].
-
Regulatory Approvals: Expanded indications, such as potential approval for hepatitis delta virus (HDV) co-infection, could sustain or boost demand, moderating price declines.
-
Market Penetration: Increasing adoption in Asia and other emerging markets could impact overall pricing strategies, with local price controls influencing premiums.
-
Generic Competition: Availability of generics will pressure prices downward, especially in the U.S. and Europe.
Implications for Stakeholders
- Pharmaceutical companies should anticipate revenue erosion starting mid-2025 with patent expiry.
- Payers and insurers will seek lower-cost alternatives once generics enter the market.
- Investors should consider patent dependency risks and the timeline for generic competition when evaluating Gilead’s hepatitis B portfolio.
Summary
Vemlidy commands high prices, sustained by its safety profile and limited competition. Price erosion is expected post-2025 as patent protections lapse and generics become available, with prices potentially halving within two years of generic market entry.
Key Takeaways
- NDC 51672-2020 (Vemlidy) generates over $42,000 per patient annually in the U.S.
- Market growth is driven by rising HBV prevalence, especially in Asia.
- Patent expiries around 2025–2026 will likely lead to significant price reductions due to generic competition.
- Price projections indicate a gradual decline, with substantial reductions post-generic approval.
- Stakeholders should prepare for evolving pricing dynamics, including regulatory and market access challenges.
FAQs
-
When will generic versions of Vemlidy become available?
Patent expiration is expected around 2025–2026 in major markets, enabling generic entry.
-
How does Vemlidy compare cost-wise to competitors?
Currently priced at approximately $3,500/month, it is more expensive than TDF-based therapies but offers a better safety profile.
-
What factors could delay price reductions?
Regulatory hurdles, patent litigations, or market exclusivity extensions could delay generic impact.
-
Are there emerging markets where Vemlidy retains pricing power?
Yes, limited generic availability and patent protections in regions like Japan and Europe support sustained premiums.
-
What is the potential impact of new indications?
Approval for additional uses, such as HDV co-infection, could increase target populations and support stable or higher pricing.
Sources
[1] World Health Organization. "Global Hepatitis Report 2017."
[2] Gilead Sciences. "Vemlidy (tenofovir alafenamide) Pricing."
[3] Evaluate Pharma. "Hepatitis B Market Outlook 2022."
