Last updated: March 3, 2026
What is the drug associated with NDC 00597-0164?
NDC 00597-0164 refers to Sovaldi (sofosbuvir), a hepatitis C virus (HCV) antiviral medication approved by the U.S. Food and Drug Administration (FDA) in December 2013. Sovaldi is a nucleotide analog inhibitor that targets the NS5B polymerase, essential for HCV replication.
What is the current market position of Sovaldi?
Sovaldi revolutionized hepatitis C treatment due to its high efficacy (>90% sustained virologic response across genotypes) and shorter treatment duration. It is prescribed as part of combination regimens, often with ledipasvir, velpatasvir, or ribavirin.
Competitors and Market Landscape
| Product |
Approval Year |
Price per 12-week course |
Market Share (2022) |
Key Competitors |
| Sovaldi (sofosbuvir) |
2013 |
$84,000 (original) |
Estimated 40% |
Harvoni, Epclusa, Vosevi |
| Harvoni (sofosbuvir/ledipasvir) |
2014 |
$94,500 |
30% |
Epclusa, Vosevi |
| Epclusa (sofosbuvir/velpatasvir) |
2016 |
$74,760 |
15% |
Vosevi, Zepatier |
| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) |
2017 |
$75,360 |
10% |
Epclusa |
Market Dynamics
- The entry of fixed-dose combination drugs has increased treatment adherence.
- Price reductions have occurred due to negotiations, biosimilar entries in other markets, and payor pressure.
- The overall HCV treatment market is declining as prevalence diminishes and cured patients exit the market.
How have pricing trends evolved?
Initial Pricing (2013-2014):
- List price at launch: approximately $84,000 for a 12-week course.
- Per-pill cost: around $1,000.
Post-Launch Adjustments:
- Manufacturers adjusted prices downward in response to payor resistance and competition.
- Discounting reports indicate payors and pharmacies often secured rebates, reducing the effective price.
Current Price Range (2022):
- Average wholesale price (AWP): $28,000–$36,000 per treatment course, depending on negotiations and geographic market.
- Medicaid and other public programs report negotiated net prices below $20,000.
- Biosimilars or generics are being developed in other territories, but U.S. patent exclusivity limits immediate generics.
What are future price projections?
Short-term (Next 1-2 years):
- Pricing is unlikely to decrease below approximately $20,000 per course due to existing patents and favorable negotiated rebates.
- Insurers and PBMs continue to seek lower-cost therapies, pushing effective prices downward.
Medium-term (3-5 years):
- Patent expiration expected around 2024–2026 in the U.S.
- Once patent expires, biosimilar competition could drive prices down 50% or more.
- Generic versions could enter the market at prices as low as $8,000–$12,000 per course, based on international benchmarks.
Long-term (5+ years):
- Market entry of biosimilars and generics may reduce Sovaldi’s market share significantly.
- The original product may retain some niche or brand loyalty, but the dominant price point will decline substantially.
Regulatory and patent landscape
- Patent protection typically extends until mid-2024, with patent challenges potentially impacting exclusivity.
- Voluntary licensing agreements in some countries have enabled more affordable access.
- The patent landscape affects generic entry speed and pricing in different regions.
Market Potential and Revenue Impact
- In 2022, global sales of Sovaldi and its combination products totaled approximately $7 billion.
- U.S. market accounted for roughly 60% of sales, driven by high treatment rates and insurance coverage.
- Estimated decline of at least 40% over the next 3 years as new therapies and generics emerge.
Key takeaways
- Original Sovaldi's launch price was $84,000 per course, with effective discounts and rebates lowering actual prices.
- Competitive products have captured substantial market share, leading to a tiered pricing landscape.
- Price projections show a decline to below $20,000 within two years, with significant reductions after patent expiration.
- The patent landscape and regulatory environment heavily influence pricing and market access.
- Long-term growth prospects diminish due to market saturation and competition from generics/biosimilars.
FAQs
1. What factors influence the future pricing of Sovaldi?
Patent expiration, generic/biosimilar entry, negotiations with payors, and market competition. Regulatory decisions and international licensing also impact prices.
2. How does the current market share of Sovaldi compare to its competitors?
While Sovaldi was the first approved, newer combination drugs like Harvoni and Epclusa now hold larger shares due to improved efficacy, safety, and dosing convenience.
3. When is patent expiration expected for Sovaldi in the U.S.?
Around mid-2024, subject to patent challenges and legal disputes.
4. What is the potential impact of biosimilars on Sovaldi's price?
Biosimilars could reduce treatment costs by 50% or more, fragmenting the market further.
5. How do international markets differ in pricing strategies?
Global prices vary significantly; many countries negotiate lower prices through government agreements or compulsory licensing, impacting global revenue projections.
References
[1] U.S. Food and Drug Administration. (2013). FDA approves Gilead's Sovaldi for hepatitis C. FDA News Release. https://www.fda.gov/news-events/press-announcements/fda-approves-gileads-sovaldi-hepatitis-c
[2] IQVIA. (2022). Global Medicine Spending and Usage Trends. IQVIA Institute.
[3] Kantar. (2022). Healthcare Market Insight Reports.
[4] PrescQIPP. (2021). Hepatitis C Treatment Cost Analysis.
