Last updated: February 20, 2026
What Is NDC 71656-0064?
NDC 71656-0064 corresponds to a specific pharmaceutical product classified under the United States National Drug Code (NDC) system. This code identifies a specialty drug. Based on available data, this particular NDC refers to Sovaldi (sofosbuvir), a major drug for hepatitis C treatment, marketed by Gilead Sciences. It received FDA approval in 2013 and significantly altered the hepatitis C therapy landscape.
Market Overview
Market Size and Growth Dynamics
The hepatitis C virus (HCV) treatment market has evolved with the introduction of direct-acting antivirals (DAAs) like sofosbuvir. Historically, the market's growth depended on the prevalence of HCV in the U.S. and globally, along with treatment penetration.
- Prevalence: An estimated 2.4 million individuals in the U.S. are HCV-positive, with global figures exceeding 71 million (WHO, 2017).
- Treatment Penetration: Since 2014, the adoption of DAAs increased sharply, with over 300,000 prescriptions annually in the U.S. by 2016, rising to approximately 400,000+ in subsequent years.
Competitive Environment
- Gilead Sciences dominates with Sovaldi and Harvoni.
- Recent entrants include AbbVie's Mavyret and Genentech's Vosevi.
- Market share concentration remains high, with Gilead holding roughly 60-70% of prescriptions post-2018.
Regulatory and Payer Dynamics
- The high drug acquisition costs prompted negotiations with payers.
- Medicare and Medicaid policies influence access; for example, Medicaid often imposes fibrosis-based eligibility criteria.
- Patient assistance programs exist but are insufficient to negate reimbursement barriers.
Historical Pricing Trends
Launch Price and Subsequent Adjustments
- Initial list price (2013): approximately $84,000 for a 12-week course.
- Per-pill cost: $1,000.
- Price reductions: Due to increased competition, rebates, and negotiations, effective net prices have fallen by 30-50% in some plans, with some payers reporting net prices around $30,000–$50,000 per treatment course.
Price Trends (2014–2022)
| Year |
Launch Price (per course) |
Estimated Net Price (per course) |
Notes |
| 2013 |
$84,000 |
N/A |
Initial pricing |
| 2015 |
$84,000 |
$60,000–$70,000 |
Early negotiations |
| 2018 |
$50,000–$70,000 |
$30,000–$50,000 |
Market entry of competitors |
| 2022 |
~$50,000 |
$20,000–$40,000 |
Increased insurer discounts |
Price Components
- List price vs. net selling price
- Rebates and discounts dominate the final cost
- Insurer negotiations influence actual patient expenditure
Future Price Projections
Key Factors Influencing Future Retail Pricing
- Patent life and biosimilar entry: Patent expiration for Sovaldi is expected around 2024–2026, opening the market to biosimilar and generic competition.
- Market penetration and treatment guidelines: Broader treatment among diverse populations, including underserved groups, will likely increase demand.
- Negotiation leverage: Payers will continue to push for lower prices, especially as more cost-effective alternatives emerge.
Predicted Trends (2023–2027)
| Year |
Estimated Average Price (per course) |
Comments |
| 2023 |
$20,000–$30,000 |
Post-patent expiration phase |
| 2024 |
$15,000–$25,000 |
Increasing generic market share occurs |
| 2025 |
$10,000–$20,000 |
Market normalization with biosimilars |
| 2026 |
<$10,000 |
Price stabilization, high competition |
Market Access Impact
- Payer pressure will push prices downward.
- Access programs may increase utilization, offsetting revenue declines.
- Substitution with biosimilars or generics expected to reduce brand sales sharply after patent expiry.
Revenue and Market Share Outlook
| Year |
Estimated U.S. Revenue |
Market Share |
Key Influencers |
| 2022 |
~$1.2 billion |
55-60% |
Dominant branded product, high penetration |
| 2023 |
$600–$800 million |
35-45% |
Generic market begins to chip away |
| 2024 |
<$400 million |
10–20% |
Biosimilars and generics gain market share |
Conclusion
The market for NDC 71656-0064, primarily representing Sovaldi (sofosbuvir), has experienced significant price declines from initial launch, driven by increased competition and payer negotiations. Future pricing will decline further as patent protections expire and biosimilars/similars enter the market. The revenue potential in the U.S. diminishes accordingly, with strategic focus shifting to global markets and combination regimens.
Key Takeaways
- Initial launch prices were approximately $84,000 per course, with net prices reducing to $20,000–$40,000 by 2022.
- Competition from newer therapies and generics will accelerate price declines post-2024.
- Market share remains substantial but will diminish as biosimilars/similars enter.
- Payer negotiations and reimbursement policies heavily influence actual transaction prices.
- Long-term revenue prospects depend on patent expiry timing and market penetration by alternatives.
FAQs
What is the primary competitor to NDC 71656-0064?
Mavyret (glecaprevir/pibrentasvir) by Abbott Laboratories and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) by Genentech.
When will patent expiry likely impact prices?
Patent expiry is projected around 2024–2026, leading to increased generic and biosimilar competition.
How do rebate programs affect the net price?
Rebates, discounts, and negotiations can reduce the net price by 30–50%, significantly lowering actual payer costs compared to list prices.
What is the global market outlook?
Global hepatitis C treatment demand remains significant, especially in regions with limited access to newer therapies. Pricing and access inequalities persist.
How do treatment guidelines influence market outlook?
Broader acceptance of oral DAAs and expanded treatment recommendations will drive demand, while price constraints will limit market growth due to payer limitations.
References
- World Health Organization. (2017). Global Hepatitis Report 2017. WHO.
- Gilead Sciences. (2013). FDA approves Sovaldi (sofosbuvir) for treatment of hepatitis C.
- IQVIA. (2022). US Prescription Data.
- Centers for Medicare & Medicaid Services. (2021). Drug pricing and reimbursement policies.
