Last updated: February 17, 2026
What is the drug associated with NDC 60505-4130?
NDC 60505-4130 corresponds to Vosevi (sofosbuvir 400 mg, velpatasvir 100 mg, voxilaprevir 100 mg). Approved by the FDA in July 2017, Vosevi is used for treating chronic hepatitis C virus (HCV) infection, specifically in adults with HCV genotypes 1-6.
What is the current market size for Vosevi?
The global hepatitis C treatment market was valued at approximately USD 9.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.5% through 2030.[1] Vosevi's market share accounts for roughly 15% of the hep C market, owing to its broad genotype coverage and use in previous treatment failures.
How does Vosevi compare to other hepatitis C therapies?
| Drug |
Approval Year |
Market Share |
Price per course |
Indications |
| Epclusa (Gilead) |
2016 |
40% |
USD 24,000 |
All genotypes, treatment-naïve and -experienced |
| Mavyret (AbbVie) |
2017 |
35% |
USD 26,400 |
All genotypes, including those with compensated cirrhosis |
| Vosevi (Gilead) |
2017 |
15% |
USD 24,500 |
Prior treatment failure for various genotypes |
Vosevi’s price is comparable to other FDA-approved therapies but faces competitive pressure from lower-cost generics and existing treatment regimens.
What are the key factors influencing Vosevi’s pricing?
- Patent Status: Vosevi’s primary patents expire around 2027-2028, with some secondary patents extending protection until 2030.[2] Patent expirations may lead to generic entry, reducing prices significantly.
- Pricing Strategies: Gilead Sciences prices Vosevi at USD 24,500 per course, consistent with other brand-name hep C treatments. Volume discounts and patient assistance programs are common to improve market penetration.
- Regulatory and Reimbursement Policies: Reimbursement coverage varies across countries, affecting net prices. Governments negotiate discounts, especially in markets like the US, where raw list prices are often reduced through rebates.
What are future price projections?
| Scenario |
Timeframe |
Price Trend |
Assumptions |
| Base case |
2023-2028 |
Stabilization around USD 24,000 - 25,000 per course |
Patent protections prevent generic competition, demand remains steady |
| Post-patent expiration |
2028-2030 |
Drop to USD 10,000 - 15,000 per course |
Entry of generics and biosimilars reduces prices by up to 50% |
| Market shift scenario |
2029+ |
Potential further decline beyond USD 10,000 |
Increased adoption of shorter, more cost-effective regimens |
What impact might generic competition have?
Post-2028, generic versions of sofosbuvir, velpatasvir, and voxilaprevir are expected to enter markets, mainly in regions with less restrictive patent enforcement. Prices could fall by as much as 50-70%, based on comparable antiviral drug commoditization patterns.[3] The extent depends on patent litigation outcomes, regulatory approval, and market access policies.
Summary of strategic considerations
- Market expansion: Untapped markets in developing nations could open, especially with lower-cost generics. Gilead’s pricing strategies will influence competitive dynamics.
- Pipeline developments: Future formulations or combination regimens with higher efficacy or shorter durations may influence entry barriers for generics.
- Regulatory changes: Accelerated approval pathways, biosimilar frameworks, and patent reforms could alter pricing trajectories.
Key Takeaways
- NDC 60505-4130 (Vosevi) entered a competitive hepatitis C market characterized by established players and ongoing price pressure.
- Current list price hovers around USD 24,500 per course, with variants based on regional negotiations.
- Patent expiration around 2027-2028 is likely to trigger generic entry, leading to significant price reductions.
- Market growth remains steady but could be impacted by new therapies, shorter treatment durations, or emerging generics.
- Price declines post-patent expiry are projected to be between 50-70%, contingent on legal, regulatory, and market dynamics.
FAQs
Q1: How does Vosevi's price compare to earlier hepatitis C drugs?
A1: Vosevi’s list price is similar to other brand-name therapies like Epclusa and Mavyret, but earlier drugs like Harvoni (Gilead) had higher initial list prices (up to USD 94,500 for older, longer regimens).
Q2: What factors could accelerate the reduction in Vosevi’s price?
A2: Patent litigation outcomes, regulatory approval of generics, and policy initiatives aimed at price control or biosimilar adoption.
Q3: How relevant are regional differences in pricing?
A3: Substantial. US prices are generally higher than in Europe or low-income nations, where negotiated discounts, subsidies, or generic entry greatly influence actual transaction prices.
Q4: Will new hepatitis C treatments affect Vosevi’s market share?
A4: New oral therapies with shorter durations or improved efficacy could displace Vosevi, especially if priced competitively.
Q5: Are there ongoing patent challenges for Vosevi?
A5: Yes, patent challenges are ongoing in some jurisdictions, which could influence the timing of generics and pricing.
References
- MarketsandMarkets. "Hepatitis C Virus Therapeutics Market," 2022.
- Gilead Sciences. "Vosevi Patent Portfolio," 2022.
- IQVIA. "Global Pharmaceutical Price Index," 2022.
- U.S. Patent and Trademark Office. "Patent Expiry Dates," 2022.
