Last updated: February 20, 2026
What Is NDC 51407-0766?
NDC 51407-0766 refers to Sofosbuvir and Velpatasvir Tablets. It is marketed as Epclusa, a hepatitis C virus (HCV) treatment approved by the FDA in June 2016. The drug combines two antiviral agents to treat all six HCV genotypes in a single daily tablet.
Market Size and Demand Drivers
Hepatitis C Epidemiology and Treatment Landscape
- Global HCV prevalence: Estimated 58 million people infected worldwide (World Health Organization, 2021).
- U.S. prevalence: Approximately 2.4 million Americans living with chronic HCV (CDC, 2020).
- Treatment adoption: Rising uptake driven by expanding screening and approval for new genotypes.
Key Factors Influencing Market Dynamics
- Advancements in Direct-Acting Antivirals (DAAs): Efficacy and shorter treatment durations have increased adoption.
- Price reduction initiatives: Industry and government efforts to lower costs.
- Generic entries: Patent expirations and biosimilar competition influence pricing and market share.
Market Segments
- Hospital and specialty clinics: Major prescribers.
- Rural and underserved areas: Growing focus, though limited access persists.
- Insurance coverage: Significant determinant of patient access and adherence.
Competitive Landscape (Selected Players)
| Manufacturer |
Product Name |
Market Share (Estimated, 2022) |
Notes |
| Gilead Sciences |
Epclusa |
65% |
Leading in global sales |
| Merck & Co. |
Zepatier |
20% |
Limited to certain HCV genotypes |
| AbbVie |
Mavyret |
10% |
Rapidly growing market presence |
| Others |
Various |
5% |
Including generic versions |
Price Trends and Projections
Current Pricing Landscape
- List Price (U.S.): Approximately $74,760 for a 12-week course, equating to roughly $62 per tablet (as of 2023).
- Average wholesale price (AWP): Slightly lower, around $59,000–$63,000.
- Insurance and Medicaid rebates: Negotiated discounts frequently reduce net prices by 50% or more.
Factors Impacting Future Prices
- Patent expiration: Expected around 2028; generic competition anticipated to reduce prices.
- Negotiated discounts: States and payers increasingly secure lower prices via formulary negotiations.
- Market penetration of biosimilars: May accelerate lower-price alternatives.
Price Projection (Next 5 Years)
| Year |
Estimated Price Range (per 12-week course) |
Notes |
| 2023 |
$50,000–$63,000 |
Current levels |
| 2024 |
$45,000–$55,000 |
Price pressure from competition |
| 2025 |
$30,000–$45,000 |
Introduction of generics |
| 2026 |
$15,000–$30,000 |
Increasing biosimilar market |
| 2027 |
<$15,000 |
Post-patent expiration |
Regulatory and Policy Influences
- FDA: Continues to monitor and approve generics and biosimilars.
- CMS and Medicaid: Favor formulary cost containment.
- Global health initiatives: Push for lower-priced generics in low-income markets.
Key Action Points
- Patent expiry: Monitor for potential patent challenges around 2028.
- Generic pipeline: Expect initial launches within 1–2 years post-patent expiry.
- Market penetration: Significant price drops will align with increased generic supply.
- Pricing negotiations: Payers will likely continue securing discounts, impacting list prices downward.
Summary
NDC 51407-0766 (Sofosbuvir and Velpatasvir) is a leading HCV treatment with strong historical sales but faces future price declines due to patent expiry, generic competition, and policy pressures. Current list prices remain high but are expected to decline substantially over the next five years, with generics potentially reducing that cost by over 75% post-2028.
Key Takeaways
- The market for NDC 51407-0766 is mature, with Gilead holding dominant share.
- Future prices will fall sharply following patent expiration, driven by generic entries.
- The total addressable market will grow with increased screening and treatment access.
- Payer and government negotiating power will lead to continued discounts.
- Close monitoring of patent status and generic pipelines is essential for accurate forecasting.
FAQs
Q1: When is patent expiration expected for Epclusa?
A: Around 2028, depending on patent disputes and extensions.
Q2: How much can prices drop after generic entry?
A: Typically by 70-80%, potentially bringing costs below $15,000 per 12-week course.
Q3: Will biosimilars affect Epclusa’s market share?
A: Yes, biosimilars could capture significant demand as they enter the market post-patent.
Q4: Are there regional price variations?
A: Yes, prices are often lower outside the U.S., especially in low-income countries due to licensing agreements.
Q5: How do negotiated rebates impact actual treatment costs?
A: Rebates can reduce net costs by more than 50%, making the drug more affordable for payers.
References
- World Health Organization. (2021). Hepatitis C. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
- Centers for Disease Control and Prevention. (2020). Hepatitis C FAQs. https://www.cdc.gov/hepatitis/hcv/cfaq.htm
- IQVIA. (2023). Global prescribing and market data.
