Last updated: February 14, 2026
Overview of the Drug
NDC 50268-0758 corresponds to Epclusa (sofosbuvir and velpatasvir), a hepatitis C virus (HCV) treatment approved by the FDA in 2016. It is indicated for genotypes 1-6 of HCV, providing a broad-spectrum, once-daily oral regimen.
Market Size and Dynamics
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Global HCV Population: Estimated at 58 million, with approximately 2.4 million in the U.S. (as of 2021) [1]. The accessible treatment market depends on the diagnosed, treatment-naïve, and insurance coverage.
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Treatment Adoption: Since approval, Epclusa has gained significant market share in HCV treatment, especially following the removal of prior authorization restrictions in some markets. However, competition has increased from other direct-acting antivirals (DAAs) such as Mavyret (glecaprevir/pibrentasvir) and Harvoni (ledipasvir/sofosbuvir).
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Patent and Exclusivity: Patents typically last until 2024-2025, with exclusivity potentially extending further through data exclusivity and formulations. Some markets face patent challenges leading to generic entry in the near term.
Market Competition
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Major competitors: Mavyret (AbbVie), Harvoni (GSK), Vosevi (Gilead), and generic versions from multiple producers.
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Market Share: Gilead's Harvoni dominated early but has seen erosion with the entry of Epclusa and newer generics.
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Pricing Trends: List prices of Epclusa have historically been around $74,760 for a 12-week treatment course in the US. Negotiated prices or discounts vary, especially with pharmacy benefit managers (PBMs) and government programs.
Price Projections and Revenue Outlook
Regulatory and Policy Factors
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Some markets are pushing for lower-cost generics, especially in developing countries, accelerating price reductions.
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Insurance policies and government tenders increasingly favor cost-effective generics over brand-name drugs.
Impact of Generics and Biosimilars
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The entrance of generics is projected to cause steep price declines once patent protections lapse.
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Countries with strong generic manufacturing capacity will likely see median prices of $12,000-$20,000 per course within 2 years post-patent expiry.
Summary and Market Outlook
| Aspect |
Current Status |
Future Trend |
| Price in US (list) |
~$74,760 per course |
Decreasing to ~$20,000 or less in 3-4 years |
| Patent expiry |
Around 2024-2025 |
Open to generic competition |
| Market share (US) |
Significant but declining |
Declines accelerating with generics |
| Revenue (2023 globally) |
~$2.2 billion |
Decline of 50-70% expected in 3-5 years |
Key Takeaways
- Epclusa remains a dominant player in HCV treatment but faces imminent patent expiry.
- Price compression will occur rapidly post-patent due to the entry of generics.
- The US market maintains higher prices, but international markets will see sharper reductions.
- R&D focus may shift toward new indications or combination therapies to sustain revenue.
FAQs
1. When does patent protection for NDC 50268-0758 expire?
Around 2024-2025, allowing generic manufacturers to enter in most markets.
2. How will the entry of generics affect Epclusa’s price?
Generics are expected to reduce the treatment course price by approximately 70-80%, with variations based on region.
3. Are there approved generic versions of Epclusa?
Yes, several generics approved in countries such as India and Egypt; US approval depends on patent litigation outcomes.
4. What factors influence the pricing trend for Hepatitis C drugs?
Patent status, approval of generics, negotiation leverage, governmental policies, and healthcare coverage determine prices.
5. Which markets will experience the largest price reductions?
Emerging markets and countries with active generic manufacturing will see significant price decreases; the US will see more moderated reductions due to contractual negotiations.
Sources
- World Health Organization, 2021. Global hepatitis report.
- IQVIA, 2022. Global healthcare Q2 report.
- Visual Capitalist, 2023. Top-selling drugs worldwide.
