Last updated: August 6, 2025
Introduction
The drug identified by NDC 00536-1213 corresponds to VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir, and Dasabuvir), a combination therapy approved by the FDA for the treatment of hepatitis C virus (HCV) Genotype 1 infection. Given its clinical importance and evolving market dynamics, understanding its current market landscape and projecting future pricing trends is vital for stakeholders, including healthcare providers, payers, and pharmaceutical investors.
Market Overview
Therapeutic Context and Market Demand
VIEKIRA PAK entered the HCV therapy arena as part of the revolutionary wave of direct-acting antivirals (DAAs). Since its FDA approval in 2015, it quickly captured market share due to high cure rates (SVR rates above 95%) and a favorable safety profile, replacing older interferon-based treatments.
The global HCV market was valued at approximately USD 8.3 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 3-4% through 2027 [1]. VIEKIRA PAK’s contribution is substantial in the U.S., where the primary demand stems from chronic HCV genotype 1 infections.
Market Penetration and Competition
While first-generation DAAs like sofosbuvir and ledipasvir dominated initial markets, newer fixed-dose combinations (e.g., Gilead's Mavyret, AbbVie's Vosevi) have introduced heightened competition since 2017. Price reductions and formulary priorities have shifted market share towards more affordable regimens.
Despite this, VIEKIRA PAK remains a preferred option for certain patient subsets, especially when resistance profiles or comorbidities influence regimen selection. Additionally, patent protections and market exclusivity keep it relevant for a mid-term horizon, with generic versions less prevalent in the U.S. but more so in international markets.
Pricing Landscape
Historical Pricing Trends
VIEKIRA PAK’s wholesale acquisition cost (WAC) upon FDA approval was approximately $63,000 for a 12-week course per patient in the U.S. Over recent years, due to intense price competition, the net price — after rebates, discounts, and patient assistance programs — has declined significantly, with some estimates placing the effective cure cost nearer to $26,000-$35,000 per treatment course [2].
Current Market Price
Market surveys from sources like SSR Health suggest that current average wholesale prices for VIEKIRA PAK range from $30,000 to $45,000 per patient, reflecting negotiated discounts. The price varies depending on payer contracts, regional reimbursement policies, and whether the patient qualifies for assistance programs.
In international markets, especially in nations with governmental price controls, VIEKIRA PAK’s price often falls below the U.S. levels, sometimes by 50% or more, making it more accessible but also influencing the global revenue streams for the manufacturer.
Future Price Projections
Factors Influencing Price Trajectory
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Patent Status and Generic Entry:
The patent for VIEKIRA PAK is expected to expire or face challenge by 2025-2027, opening the market to generic producers. Generic competition typically drives prices downward by 50-80%, as observed in prior DAA class medicine launches [3].
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Market Competition and Emergence of New Therapies:
Newer pan-genotypic regimens with shorter treatment durations and lower prices entered the marketplace over the last few years. The upward pressure on VIEKIRA PAK’s price diminishes as clinicians pivot towards these alternatives, especially when coverage is limited by cost or formulary restrictions [4].
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Reimbursement and Policy Changes:
Payer policies favor lower-cost regimens, and government initiatives aim to reduce HCV treatment costs. The push for eradication programs, particularly in Medicaid and Medicare, is likely to accelerate price discounts for branded drugs.
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Regulatory and Patent Litigation:
Patent challenges may accelerate the entry of generics, catalyzing rapid price declines. Conversely, strong patent defenses might prolong higher prices, but market trends suggest the eventual decline is inevitable [5].
Projected Price Range (2023-2030)
Based on these dynamics, including historical analogs and market analyses:
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2023-2024:
Prices are expected to stabilize around $25,000 - $35,000 per course, with negotiations reflecting payer-specific discounts and assistance programs.
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2025-2027:
With patent expiry and generic arrival, prices could decline sharply, reaching $10,000 - $15,000 per course within the first year of generic availability.
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2028-2030:
Post-generic market establishment, prices could plateau or slightly decline further, potentially settling around $8,000 - $12,000 per course, influenced by manufacturing costs and competitive pressures.
Implications for Stakeholders
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Pharmaceutical Companies:
Anticipate significant revenue erosion post-patent expiry. Strategies should include diversification into broader antiviral portfolios or value-added services, such as biosimilars or combination therapies.
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Payers and Providers:
Should prioritize cost-effective, evidence-based regimens balancing clinical efficacy and affordability. Anticipate increased negotiations and formulary restrictions to manage rising demand for newer, cheaper options.
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Investors:
Must consider patent life cycles and the timing of generic entry when valuing current assets. Patent protections bolster near-term revenues but decline markedly post-expiry.
Conclusion
The market for NDC 00536-1213, VIEKIRA PAK, is characterized by high initial prices, intense competition, and impending price reductions driven by patent expiration and generics. While it remains clinically relevant, especially in the short to medium term, its pricing will trend downward sharply over the next five years. Stakeholders must adapt strategies aligned with these forecasts to optimize outcomes and financial performance.
Key Takeaways
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Current retail price for VIEKIRA PAK in the U.S. hovers around $30,000 to $45,000 per treatment course, but effective prices are often lower after discounts and assistance programs.
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Market competition and patent expiration forecast a steep price decline beginning around 2025, with generic versions significantly reducing costs.
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International markets offer lower pricing due to price regulations, creating opportunities for global distribution but reducing U.S. revenue margins.
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Clinicians and payers should monitor evolving therapeutic options and pricing, emphasizing cost-effective, evidence-based treatment selection.
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Pharmaceutical firms should prepare for revenue declines post-patent expiration and explore strategic shifts in their antiviral pipeline to maintain market relevance.
FAQs
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When will generic versions of VIEKIRA PAK become available in the U.S.?
Patent challenges and expirations are projected around 2025–2027, which would permit generic manufacturing and market entry.
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Will the price of VIEKIRA PAK decrease before patent expiry?
Price reductions are expected gradually due to market competition, negotiations, and payer discounts, but most significant declines align with patent expiration and generic entry.
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Are there alternative therapies that are more cost-effective than VIEKIRA PAK?
Yes, newer pan-genotypic regimens like Mavyret and Vosevi often provide similar or superior efficacy at lower costs, influencing prescribing patterns.
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How do international prices of VIEKIRA PAK compare to U.S. prices?
International prices are generally lower due to tighter price controls, impacting global revenue but expanding treatment access worldwide.
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What strategies should payers adopt to manage costs related to HCV treatments?
Prioritize cost-effective, pan-genotypic regimens, implement formulary controls, negotiate volume discounts, and support programs that optimize treatment adherence.
Sources
[1] Fortune Business Insights, "Hepatitis C Treatment Market Size, Share & Industry Analysis, 2022-2029," 2022.
[2] SSR Health, "Net Pricing Data for Hepatitis C Medications," 2021.
[3] Gilead Sciences Annual Report, 2022.
[4] Centers for Disease Control and Prevention (CDC), "HCV Treatment Trends," 2022.
[5] Patent and Litigation Databases, "VIEKIRA PAK Patent Challenges," 2022.
