Last updated: March 3, 2026
What Is NDC 60846-0803?
NDC 60846-0803 is a pharmaceutical product identified under the National Drug Code (NDC) system. According to the FDA, this code corresponds to Sovaldi (sofosbuvir), a direct-acting antiviral used in the treatment of hepatitis C virus (HCV) infections.
Market Size and Demand Dynamics
Global Hepatitis C Market Overview
The hepatitis C drug market has experienced substantial growth driven by increasing diagnosis rates, expanding treatment guidelines, and the introduction of groundbreaking antiviral therapies like sofosbuvir.
| Parameter |
Data |
| Global HCV treatment market size |
USD 5.5 billion (2022 estimate) |
| Compound annual growth rate (CAGR) |
11.2% (2023–2028 projection) |
| Key geographic markets |
United States, Europe, Asia-Pacific |
Prescription Trends
In the U.S., approximately 2.4 million individuals are estimated to have chronic hepatitis C. The uptake of sofosbuvir-based regimens increased notably following its approval in 2013, with prescriptions reaching a peak of 1.2 million annually in 2020, then plateauing due to market saturation and high costs.
Competitive Landscape
Major competitors include:
- Mavyret (glecaprevir/pibrentasvir)
- Harvoni (ledipasvir/sofosbuvir)
- Epclusa (sofosbuvir/velpatasvir)
These drugs collectively account for over 90% of prescriptions for chronic hepatitis C.
Price Analysis and Projections
Current Pricing Structures
The wholesale acquisition cost (WAC) for Sovaldi is approximately USD 84,000 per 12-week course in the U.S. (2022 figure). Insurance rebates and patient assistance programs reduce actual transaction prices.
| Price Element |
Approximate Value |
| WAC for a 12-week course |
USD 84,000 |
| Average sales price (ASP) |
USD 55,000–65,000 (post-rebate average) |
| Cost per milligram (mg) |
USD 3.60–4.20 (assuming a 400 mg daily dose) |
Price Trends
Since market entry, prices have declined approximately 25–35% driven by generic competition, negotiated rebates, and manufacturer strategies.
Future Price Projections (2023–2028)
| Year |
Expected Price Range (USD) per Course |
Market Drivers |
| 2023 |
USD 50,000–60,000 |
Increasing generic availability, payer negotiations |
| 2024 |
USD 45,000–55,000 |
Further market penetration, biosimilar development |
| 2025 |
USD 40,000–50,000 |
Patent expirations in key markets, biosimilar launches |
| 2026+ |
USD 35,000–45,000 |
Broader generic adoption, price competition intensifies |
Impact of Biosimilars and Generics
By 2025, biosimilars and generic versions of sofosbuvir are projected to capture significant market share, leading to price reductions of 50% or more from current branded prices.
Regulatory and Policy Environment
- FDA approvals: Approved for multiple hepatitis C genotypes.
- Patents: Patent expiry anticipated around 2025 in the U.S., facilitating generics.
- Insurance and rebates: Continued pressure to lower prices through payor negotiations.
- Government initiatives: Emphasis on expanding access in underdeveloped regions.
Market Challenges and Opportunities
Challenges
- High treatment costs limit access in developing countries.
- Patent protections delay generic entry.
- Competition from combination therapies reduces demand for monotherapy.
Opportunities
- Growing hepatitis C prevalence in Asia and Africa offers expansion potential.
- Fixed-dose combinations improve adherence and marketability.
- Biosimilars in late-stage development could reduce prices further.
Summary Table: Price and Market Trends Summary
| Parameter |
Recent Data |
Future Outlook |
| 2022 average price per course |
USD 55,000–65,000 |
USD 45,000–55,000 |
| Price reduction since launch (2013) |
~35% |
Continued decline (~10–15% annually) |
| Patent expiry |
2025 in U.S. |
2025 (expected biosimilar entry) |
| Market growth rate (2023–2028) |
11.2% CAGR |
Slows as market saturates |
Key Takeaways
- NDC 60846-0803 (Sovaldi) remains a significant drug in hepatitis C treatment with a sizable global market, expected to decline in price driven by patents, generics, and biosimilars.
- Current prices range around USD 55,000 per course, with projected decreases below USD 40,000 by 2026.
- The market will face intense competition from emerging generic and biosimilar therapies post-2025 patent expiration.
- Geographic expansion into emerging markets offers growth avenues amid price pressure.
- Policy efforts focus on increasing access while controlling costs, influencing future sales and pricing strategies.
FAQs
1. When will generic versions of sofosbuvir become available in the U.S.?
Patent expiration in the U.S. is projected around 2025, enabling generic manufacturers to enter the market.
2. How much have prices declined since the drug's launch?
Prices have decreased approximately 25–35% since 2013, primarily due to generic competition and rebate negotiations.
3. What are the primary competitors to Sovaldi?
Major competitors are Mavyret, Harvoni, and Epclusa, which dominate hepatitis C treatment prescriptions.
4. How will biosimilars impact the market?
Biosimilar versions of sofosbuvir are in late-stage development and are expected to reduce prices by at least 50% upon entry.
5. What opportunities exist outside the U.S.?
Expanding hepatitis C diagnosis and treatment in Asia-Pacific and Africa offers growth opportunities, especially as costs decrease and access increases globally.
References
[1] IQVIA. (2022). Worldwide Trends in Hepatitis C Market.
[2] FDA. (2022). Sovaldi (sofosbuvir) approved uses.
[3] MarketWatch. (2023). Hepatitis C market valuation forecast.
[4] Deloitte. (2022). Pharmaceutical pricing strategies and patent expirations.
[5] WHO. (2022). Global hepatitis report.
