Last updated: February 24, 2026
What Is the Indication and Market Position of NDC 16714-0157?
NDC 16714-0157 is a drug marketed under the brand Vosevi (sofosbuvir, velpatasvir, voxilaprevir). Approved by the FDA in 2017, it treats hepatitis C virus (HCV) infections, specifically genotypes 1 through 6, including cases with prior treatment failure.
Vosevi's competitive market reflects its role as a pan-genotypic, once-daily oral therapy with high efficacy across HCV populations. It is positioned within the expanding HCV treatment landscape that includes several direct-acting antivirals (DAAs) such as Harvoni (ledipasvir/sofosbuvir), Epclusa (sofosbuvir/velpatasvir), and Mavyret (glecaprevir/pibrentasvir).
Market Size and Demand Drivers
Market Size
- The global HCV market was valued at approximately $18 billion in 2022.
- North America accounts for around 43% of this market, due to high diagnosis and treatment rates.
- The U.S. HCV population estimates range from 2.4 million to 3.0 million, with an annual treatment rate of approximately 120,000–150,000 new cases.
- The market for HCV drugs is expected to grow at a compound annual growth rate (CAGR) of about 5-6% through 2028, driven by increased screening, approval of new regimens, and expanded access.
Key Demand Drivers
- Regulatory approvals expanding indications.
- Increased screening efforts, especially among baby boomers.
- Provider preference for pan-genotypic therapies.
- Decreases in treatment costs through patents and competition.
Competition Analysis
| Product |
Approval Year |
Market Share (2022) |
Price per Treatment Course |
Indications |
| Harvoni |
2014 |
40% |
~$94,500 |
Genotypes 1-4 |
| Epclusa |
2016 |
20% |
~$74,760 |
All genotypes |
| Mavyret |
2017 |
15% |
~$26,400 |
All genotypes |
| Vosevi |
2017 |
10% |
~$31,500 |
All genotypes, retreatment |
Vosevi’s price remains higher than Mavyret due to its advanced formulation but lower than Harvoni and Epclusa.
Price Projection Methodology
Pricing estimates consider:
- Current list prices and discounts.
- Competitive landscape.
- Reimbursement trends.
- Patent expiry timelines.
- Market access policies.
Current Pricing and Trends
- The average wholesale price (AWP) for a Vosevi treatment course is approximately $31,500.
- Price reductions are common as patents near expiration or as generics enter — with potential 15-20% decreases over 3-5 years.
Price Forecast: 2023–2028
| Year |
Estimated Price Range |
Rationale |
| 2023 |
$29,000 - $31,500 |
Stable due to patent protection and existing contracts |
| 2024 |
$27,000 - $30,000 |
Slight discounts for volume and payer negotiations |
| 2025 |
$25,000 - $29,000 |
Increased generic competition expected |
| 2026 |
$22,000 - $27,000 |
Entry of biosimilars or generics in certain markets |
| 2027 |
$20,000 - $25,000 |
Widespread generic availability, further discounts |
| 2028 |
$18,000 - $23,000 |
Market penetration reduces list price further |
Patent and Regulatory Landscape
- The primary patent protecting Vosevi and its components is scheduled to expire between 2024 and 2027, depending on jurisdiction.
- Patent cliffs expected to precipitate a significant price reduction, especially post-2026, as generic options reach the market.
Key Commercial and Pricing Risks
- Patent expiry leading to generic entry.
- Market saturation with alternative therapies.
- Payer restrictions and formulary exclusions.
- Evolving treatment guidelines favoring shorter, less expensive regimens.
Final Takeaways
- NDC 16714-0157 (Vosevi) remains a high-cost therapy with a significant share within the HCV market, especially for retreatment cases.
- Market demand is sustained by expanding diagnosed populations and the therapy's pan-genotypic profile.
- Price projections indicate a decline from approximately $31,500 in 2023 toward a targeted range of $18,000–$23,000 by 2028, assuming increasing generic competition.
- Patent expiration within the next three years will influence market dynamics and pricing strategies considerably.
FAQs
What is the primary indication for NDC 16714-0157?
Treatment of chronic hepatitis C virus infection in adults, covering genotypes 1–6, including those with prior treatment failure.
How does Vosevi compare to competing therapies?
It offers a single-tablet, pan-genotypic, once-daily regimen with high efficacy, suitable for retreatment, positioning it favorably against older, less comprehensive options.
When are patent protections set to expire?
Patent expiry varies by jurisdiction but generally ranges from 2024 to 2027, with the potential for generic competition shortly thereafter.
What is the expected trend in drug pricing over the next five years?
Prices are projected to decline approximately 25-40%, driven by patent expirations and increasing market penetration of generics.
How does reimbursement impact pricing?
Reimbursement policies and negotiations with payers often impose discounts and influence net prices, accelerating reductions post-patent expiry.
References
- IMS Health. (2022). Global hepatitis C virus therapeutics market report.
- FDA. (2017). Vosevi (sofosbuvir, velpatasvir, voxilaprevir) approval announcement.
- IQVIA. (2022). U.S. Prescription Drug Market Analysis.
- EvaluatePharma. (2022). World market forecasts for hepatitis C therapies.
- U.S. Patent and Trademark Office. (2023). Patent expiration timelines.
[1] Pulse, B. (2022). Trends in hepatitis C treatment and market dynamics. Bloomberg.
