Last updated: July 27, 2025
Introduction
The drug identified by National Drug Code (NDC) 27241-0256 refers to a specific pharmaceutical product—most often a prescription medication—whose market dynamics are shaped by therapeutic class, patent status, regulatory landscape, and market competition. Accurate market analysis and price projection necessitate an understanding of these factors, current treatment landscapes, and economic influences shaping the drug's demand and valuation.
Therapeutic Class and Indication
NDC 27241-0256 corresponds to Vemlidy (tenofovir alafenamide) tablets, developed by Gilead Sciences. Vemlidy is primarily indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease. It belongs to the broader class of antiviral agents, specifically those targeting hepatitis B.
The efficacy, safety profile, and patent exclusivity of Vemlidy have established it as a key player within HBV management, especially favored for its lower toxicity profile compared to earlier tenofovir formulations like Viread (tenofovir disoproxil fumarate).
Market Landscape and Competitive Environment
Prevalence and Market Size
Chronic hepatitis B affects approximately 296 million people worldwide, with the U.S. contributing an estimated 1.2 million cases [1]. The prevalence drives a robust demand for antiviral therapies, expected to maintain steady growth with increasing awareness and improved diagnosis.
Current Market Players
Vemlidy competes chiefly with Viread (tenofovir disoproxil fumarate), along with generics entering the landscape as patent protections lapse. The drug's positioning as a more tolerable alternative enhances its uptake.
Other players include Baraclude (entecavir) and emerging generic formulations, intensifying competition, especially as patent exclusivity diminishes.
Patent and Regulatory Status
Gilead secured extended patent protection in the U.S., expected to last until 2029-2030 [2], providing a period of market exclusivity. However, patent litigations and patent cliff situations influence future generic entry and pricing.
Regulatory approvals from agencies like the FDA bolster its market strength, with Vemlidy's indication scope critical for sustained demand.
Pricing Dynamics and Historical Trends
Current Pricing Landscape
As of recent data, Vemlidy's average wholesale price (AWP) hovers around $2,600 to $3,000 per month, translating to approximately $30,000 to $36,000 annually [3]. These figures reflect brand-name drug pricing in the U.S., driven by the high cost of antiviral therapies but subject to insurer negotiations, pharmacy benefit manager (PBM) discounts, and patient assistance programs.
Factors Affecting Price Movements
- Patent Protection & Exclusivity: Strong patent positions sustain premium pricing.
- Generic Entry: When generics enter, prices typically decline by 50% or more.
- Market Demand and Prescribing Trends: Increased awareness and screening can elevate demand, supporting stable or rising prices.
- Regulatory Changes: Approvals for broader indications or formulations can impact pricing.
Future Price Projections
Short to Medium Term (Next 3-5 Years)
Given the patent protection until approximately 2029, Vemlidy is poised to sustain its current pricing, potentially with modest annual increases aligned with inflation and healthcare cost trends. The absence of immediate generic competitors supports this outlook.
However, as patent expiry approaches, a gradual price decline, potentially by 30-50%, is anticipated due to the influx of generics and biosimilars, especially given the high demand within the HBV treatment segment.
Long-Term (Beyond 5 Years)
Post-patent expiration, the market will likely see significant price erosion, driven by generic manufacturing and increased competition. Nonetheless, price floors may be maintained for branded versions via secondary patents, formulations, or combination therapies.
Additionally, real-world factors such as biosimilar development, biosimilar switches, and market-specific healthcare policies (e.g., value-based pricing) could influence long-term price trajectories.
Economic and Regulatory Influences
- Policy impacts such as Medicare Part D negotiations and the rising trend of formulary restrictions could pressure prices downward.
- Innovation in delivery or formulation (e.g., fixed-dose combination therapies) might sustain premium prices.
- Market exclusivity extensions through orphan drug or new indication designations could temporarily enhance pricing power.
Implications for Stakeholders
Manufacturers
For Gilead, maintaining aggressive marketing and patent protections within the current timeframe is crucial to uphold revenue streams. Strategic planning for competitive responses as expiry approaches is vital to mitigate revenue erosion.
Healthcare Providers and Payers
Insurance and PBM negotiations play pivotal roles in formulary placement and reimbursement rates, directly influencing patient access and overall market prices.
Investors
Sustained revenue projections depend heavily on patent protection status, competitive landscape evolution, and regulatory developments, necessitating vigilant market monitoring.
Key Takeaways
- Market size for NDC 27241-0256 (Vemlidy) remains significant within HBV therapy, supported by global and U.S. prevalence.
- Current pricing averages around $30,000 to $36,000 annually, maintained by patent exclusivity.
- Patent protection extends until approximately 2029-2030, with imminent generic entry likely to cause substantial price reductions.
- Short-term outlook suggests stable or slightly increasing prices; long-term projections anticipate decline post-generic entry.
- Strategic positioning for Gilead hinges on patent stewardship, pipeline expansion, and potential formulation innovations.
FAQs
1. When is patent expiration expected for NDC 27241-0256 (Vemlidy)?
Patent protections extend until approximately 2029-2030, after which generic competitors are expected to enter the market, leading to price reductions.
2. How does the market for HBV treatments influence the price of Vemlidy?
High global prevalence and treatment demand sustain current pricing, but increased competition from generics and alternative therapies will exert downward pressure over time.
3. Are there biosimilars or generic versions already available?
As of now, no biosimilars or generics are approved in the U.S., but generic versions of tenofovir alafenamide are expected to emerge once patent protections lapse.
4. What factors could sustain higher pricing for Vemlidy beyond patent expiration?
Innovations like combination therapies, new indications, or regulatory exclusivities could prolong premium pricing even after patent expiry.
5. How do payer strategies impact the drug’s market price?
Payer negotiations, formulary placements, and rebate agreements significantly influence actual prices paid, often reducing net costs below the wholesale price.
References
- World Health Organization. "Global Hepatitis Report 2017."
- Gilead Sciences. "Vemlidy patent protection and market exclusivity timelines."
- GoodRx. "Vemlidy drug prices and discounts."
This analysis provides a comprehensive outlook on the current market standing and future price prospects for NDC 27241-0256, serving as a strategic resource for industry stakeholders seeking informed projections.
