Last updated: February 23, 2026
What is the drug identified by NDC 16714-0955?
The NDC (National Drug Code) 16714-0955 corresponds to Vosevi (sofosbuvir/velpatasvir/voxilaprevir). It is an antiviral medication used to treat chronic hepatitis C virus (HCV) infection in adult patients, particularly those who have previously received treatment or failed previous therapies.
What is the current market landscape?
Market Size and Demand
The global hepatitis C treatment market was valued at approximately USD 5.2 billion in 2021. The U.S. accounts for a significant share, with over 2 million diagnosed cases. The demand for Vosevi and similar direct-acting antivirals (DAAs) has been sustained due to:
- High cure rates (>95%)
- Short treatment durations (8–12 weeks)
- Reduced side-effect profiles compared to earlier regimens
Competitive Environment
Vosevi faces competition from several other DAAs, such as:
- Harvoni (ledipasvir/sofosbuvir)
- Epclusa (sofosbuvir/velpatasvir)
- Mavyret (glecaprevir/pibrentasvir)
These comparable drugs vary in pricing, dosing schedules, and approved indications but generally compete in the same treatment niche.
Regulatory and Payer Landscape
The FDA approved Vosevi in July 2017. Payer negotiations favor high-cost treatments, with value-based contracting increasingly common. While direct list prices remain high, rebates, discounts, and patient assistance programs influence actual transaction prices.
What are the current pricing dynamics?
List Price
The wholesale acquisition cost (WAC) for Vosevi is approximately USD 44,760 for a 12-week course [1]. This positions it among the more expensive HCV agents, reflecting its efficacy in difficult-to-treat populations.
Actual Transaction Price
Rebates and discounts reduce the net price. Based on industry reports, the net price paid by insurers or pharmacy benefit managers (PBMs) is approximately USD 15,000–USD 20,000 per treatment course. This variability depends on negotiated agreements and patient assistance.
Pricing Trends
- Since approval, list prices have remained relatively stable.
- Some reduction in net pricing occurs due to increased competition and payer pressure.
- The high cost persists despite multiple generic versions in some markets, which are limited due to patent protections.
What are the patent and regulatory protection statuses?
Vosevi is protected by patent exclusivity until at least 2030 in the U.S. [2]. Patent extensions, formulations, or combination patents could extend generic entry timelines. No approved generic competitors currently market the drug in the U.S.
Price projections (Next 5 years)
Assumptions
- No significant patent litigations or challenges
- Continued focus on reducing treatment costs
- Increased use of generic versions overseas
- Sustained demand driven by treatment guidelines
Projections
| Year |
Estimated List Price (USD) |
Estimated Net Price (USD) |
Notes |
| 2023 |
44,760 |
15,000–20,000 |
Stable, with minor discounts |
| 2024 |
44,760 |
14,500–19,500 |
Slight discounting due to payer negotiations |
| 2025 |
43,000 |
13,500–18,500 |
Possible introduction of biosimilars in select markets |
| 2026 |
42,000 |
13,000–17,500 |
Increasing generic availability outside U.S. |
| 2027 |
40,500 |
12,500–17,000 |
Continued downward trend, patent protections remain |
Key Factors Influencing Price Trends
- Patent expiry and patent challenges
- Regulatory approval of generics or biosimilars
- Changes in treatment guidelines favoring or restricting use
- Negotiations with payers and government agencies
- Price controls or importation policies in different jurisdictions
International Market Considerations
Outside the U.S., especially in countries with compulsory licensing or robust generic markets, prices for Vosevi are significantly lower, averaging USD 1,000–USD 3,000 per course.
What is the outlook for sales and market penetration?
Sales volume will depend on:
- Diagnosis rates and screening programs
- Adoption of Vosevi for its indicated populations
- Competition from newer or generic agents
- Pricing policies and formulary placements
Projected annual sales could reach USD 250–USD 300 million in the U.S. by 2025, contingent on market penetration and formulary acceptance.
Key Takeaways
- NDC 16714-0955 (Vosevi) is a last-line HCV treatment with high efficacy but high list prices.
- Current list price remains stable at approximately USD 44,760 per course; net prices are lower due to discounts.
- Patent protections delay generic entry until at least 2030 in the U.S.
- Price declines are expected over the next five years, driven by patent expiration and increased generic competition domestically and internationally.
- The market remains favorable for high-cost specialty drugs with limited competition, but pricing pressures are rising.
FAQs
1. When will generic versions of Vosevi become available in the U.S.?
Generic competition is unlikely before 2030 due to existing patents and patent extensions.
2. How does Vosevi compare pricing-wise with other HCV treatments?
Vosevi has a higher list price than some competitors like Mavyret but similar to other branded DAAs, reflecting its role in resistant or pre-treated populations.
3. Are there any upcoming regulatory changes that could influence pricing?
Potential changes include policy shifts favoring biosimilars, increased patent challenges, or reforms in drug pricing regulation at federal or state levels.
4. What regions offer the most cost-effective access to Vosevi?
Most cost-effective access occurs in countries with compulsory licensing or significant generic manufacturing, such as India or certain Latin American nations.
5. What factors could accelerate Vosevi’s market decline?
Introduction of lower-cost generics, new treatment approvals with better profiles, or patent litigation outcomes could shorten its market dominance.
References
[1] Drug Channels Institute. (2022). Vosevi pricing data.
[2] U.S. Patent and Trademark Office. (2023). Patent status for Vosevi.
[3] IQVIA. (2022). Global hepatitis C market report.
[4] FDA. (2017). Vosevi approval announcement.
