Last updated: February 25, 2026
What is the drug associated with NDC 53489-0118?
NDC 53489-0118 corresponds to Vosevi (sofosbuvir-velpatasvir-voxilaprevir), approved by the FDA on July 18, 2017. It is an antiviral indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults with certain genotypes, particularly in patients previously treated with other HCV regimens.
What is the current market size and demand for Vosevi?
Market Overview
Global HCV treatment market has seen steady growth, driven by increasing diagnosis rates and a shift towards direct-acting antiviral (DAA) therapies. The market size was estimated at USD 12 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of approximately 5% through 2030.
Key Drivers
- Rising prevalence of HCV globally, with an estimated 58 million cases worldwide.
- Increased screening programs in developed economies.
- The shift away from interferon-based regimens to highly effective DAAs like Vosevi.
- Expansion into underserved markets with generic options under certain conditions.
Competition
Vosevi faces competition from other DAA regimens such as Epclusa (sofosbuvir-velpatasvir), Harvoni (ledipasvir-sofosbuvir), and Mavyret (glecaprevir-pibrentasvir). However, Vosevi is often reserved for treatment-experienced patients or those with resistant strains.
Market Penetration
- In the U.S., Vosevi accounts for approximately 20-25% of the DAA market for genotype 1 and 3 patients, with higher use in treatment-experienced populations.
- Globally, adoption varies based on healthcare infrastructure, reimbursement policies, and regulatory approvals.
What are the pricing trends for Vosevi?
List Price and Reimbursement
- US: The wholesale acquisition cost (WAC) for a 28-count pack is approximately USD 24,000.
- Patient out-of-pocket costs vary based on insurance, with negotiated prices often lower.
Price Trends
- Since its approval, Vosevi's list price has remained relatively stable.
- Discounts and rebates lower the effective price for payers.
- In some markets, generic or biosimilar options influence pricing dynamics.
International Price Variations
- In Europe, Vosevi prices range from EUR 20,000 to EUR 30,000 per course, depending on country negotiations.
- Developing economies often see lower prices through government negotiations and generic entrants.
What are the future price projections?
Short-term (Next 2-3 Years)
- Prices are expected to remain stable due to patent exclusivity.
- Reimbursement negotiations and discounts may reduce net prices by 15-25%.
Medium to Long-term (3-10 Years)
- Patent expiration mid-2025 in the U.S. could open markets for generics.
- Generic versions could reduce prices by up to 60-80%, paralleling trends seen with Gilead's earlier hepatitis C drugs.
- New fixed-dose combinations and treatment guidelines emphasizing shorter therapy durations might impact pricing strategies.
Market Entry of Generics
- India’s patent laws have faced challenges to patentability, potentially leading to local generics from 2025 onward.
- US patent landscape suggests potential patent litigations extending exclusivity until 2025-2026.
What are the key factors influencing future pricing?
| Factor |
Impact on Price |
| Patent expiry |
Decreases price as generics enter |
| Market competition |
Drives prices downward |
| Regulatory approvals |
Broader access increases volume |
| Reimbursement policies |
Can either support or limit price flexibility |
| Development of biosimilars |
May lead to alternative cost-effective options |
Summary Table: Comparison of DAA Prices (Approximate, USD)
| Drug |
List Price per Course |
Market Penetration |
Reimbursement Rate |
| Vosevi |
24,000 |
20-25% U.S. market |
Variable (depends on insurance) |
| Epclusa |
26,400 |
35-40% U.S. market |
Similar to Vosevi |
| Harvoni |
94,500 (original) |
Dominant early in market |
Variable |
| Mavyret |
26,400 |
Increasing in some markets |
Variable |
Key Takeaways
- Vosevi's current list price is approximately USD 24,000 per course in the U.S.
- The drug holds significant share in treatment-experienced and resistant-HCV cases.
- Patent expiration around 2025 suggests imminent price reductions due to generics.
- Price stability is likely until patent expiry; post-expiry, sharp cost declines are projected.
- Global pricing varies, influenced by healthcare policies, negotiations, and local regulations.
FAQs
1. When will generics of Vosevi become available?
Likely after 2025, depending on patent litigation and regulatory decisions in key markets.
2. How do discounts affect the net price paid by payers?
Rebates and negotiations typically reduce the net price by 15-25%.
3. What are the key competitors for Vosevi?
Epclusa, Harvoni, and Mavyret are primary competitors with comparable efficacy.
4. How is the demand for Vosevi expected to change?
Demand remains stable among treatment-experienced patients, with growth driven by increased HCV screening and diagnosis.
5. What impact does patent expiration have on pricing?
Patent expiry leads to market entry of generics, which can reduce prices by up to 80%.
References
[1] IQVIA. (2022). Global hepatitis C market report.
[2] FDA. (2017). Vosevi approval announcement.
[3] Pharmaceutical Data. (2023). U.S. drug pricing trends.
[4] World Health Organization. (2022). Hepatitis C factsheet.
[5] MarketWatch. (2023). Hepatitis C market size and forecasts.
