Last updated: March 3, 2026
What is NDC 70000-0333?
NDC 70000-0333 is a medication listed in the National Drug Code (NDC) database. Based on available sources, this NDC code corresponds to Sofosbuvir and Velpatasvir 400 mg/100 mg tablets, marketed under the brand name Epclusa. It is an antiviral used for treating chronic hepatitis C virus (HCV) infection across all genotypes.
Market Landscape
Market Size
The global hepatitis C treatment market is projected to reach USD 15.3 billion by 2027, growing at a CAGR of approximately 4.6%. The expansion is driven by increased screening, diagnosis, and availability of direct-acting antivirals (DAAs) like Epclusa.
Market Penetration and Competition
Primary competitors include:
- Harvoni (ledipasvir/sofosbuvir)
- Mavyret (glecaprevir/pibrentasvir)
- Vosevi (sofosbuvir/velpatasvir/voxilaprevir)
Epclusa's broad genotype coverage and simplified regimen provide competitive advantages.
Geographical Distribution
- United States: Largest market, with an estimated 2.4 million Americans infected with HCV.
- Europe: Expansion facilitated by national health programs and pricing negotiations.
- Emerging Markets: Growing demand due to increasing screening efforts.
Pricing Analysis
Current Pricing (United States)
- Average Wholesale Price (AWP): Approximately $3,750 for a 28-count package (per 4-week course).
- List Price: Around $74,600 annually if dosage is maintained continuously.
- Net Price: Negotiated prices through Medicaid and private payers typically lower.
Pricing Trends
- Since FDA approval in June 2016, prices have declined by roughly 20% due to increased competition and market maturation.
- Manufacturer rebates and discounts heavily influence actual payer costs.
Price Projections
| Year |
Estimated Price per 28-day Course |
Notes |
| 2023 |
$3,500 - $3,750 |
Current market rate, stable due to competition |
| 2024 |
$3,200 - $3,500 |
Slight decrease expected with potential biosimilar or generics in limited markets |
| 2025 |
$3,000 - $3,200 |
Continued price erosion, especially in emerging markets |
| 2026 |
$2,800 - $3,000 |
Further competitive pressure expected |
Factors Influencing Future Prices
- Generic Entry: Pending patent challenges could introduce lower-cost generics, especially outside the U.S.
- Regulatory Decisions: Changes affecting patent exclusivity could accelerate generic market entry.
- Payer Negotiations: Increased volume-based discounts may lower prices.
- Market Saturation: As treatment rates plateau, manufacturers may reduce pricing to maintain share.
Future Market Dynamics
- Increasing global screening efforts will expand the treated population.
- Biosimilar and generic competitors will exert downward pressure.
- Price reductions will likely be more pronounced in markets with government price controls, such as Europe and other OECD countries.
Key Takeaways
- NDC 70000-0333 (Sofosbuvir and Velpatasvir) faces a competitive landscape with multiple approved treatment options.
- U.S. list prices hover around $74,600 annually, with net prices significantly lower due to negotiated discounts.
- Market projections suggest prices could decline by approximately 4-6% annually over the next three years.
- Patent expirations and regulatory actions could accelerate generic entry, further reducing market prices in the coming years.
FAQs
1. When is generic versions of Epclusa expected to enter the market?
Generic entry may occur as early as 2024-2025, contingent on patent litigation outcomes and regulatory approvals.
2. How does Epclusa compare price-wise to other HCV treatments?
Epclusa's price per 28-day course is comparable to Mavyret and Vosevi, but it offers broader genotype coverage, influencing pricing strategies.
3. Are there government price controls affecting Epclusa?
Yes. Countries with national health systems often set caps on drug prices, influencing market prices and reimbursement rates.
4. What impact will biosimilars have on Epclusa's pricing?
Biosimilar competition is expected to drive prices down, especially outside the U.S., where patent protections are weaker.
5. How is the treatment adoption curve affecting future revenues?
High initial adoption due to effective therapy has plateaued; future revenues depend heavily on pricing adjustments and broader market access.
References
- IQVIA. (2023). Global hepatitis C market analysis.
- U.S. Food and Drug Administration. (2016). Approval of Epclusa.
- CBO. (2019). Analysis of hepatitis C treatment costs.
- MarketsandMarkets. (2022). Hepatitis C drugs market by region and type.
- Medtech Insights. (2023). Pricing and reimbursement strategies for HCV drugs.
