Last updated: February 19, 2026
What is the drug identified by NDC 50474-0599?
The National Drug Code (NDC) 50474-0599 refers to Sofosbuvir and Velpatasvir (Brand name: Epclusa). It is an FDA-approved oral combination therapy for chronic hepatitis C virus (HCV) infection, targeting genotypes 1-6. Approved in June 2016, Epclusa became a first-line treatment option owing to its once-daily dosing, high efficacy, and broad genotype coverage.
Current Market Landscape
Market Size and Demand
- Global Hepatitis C market valued at approximately $20 billion in 2022.
- U.S. Hepatitis C patient population estimated at 2.7 million individuals, with approximately 90% receiving treatment.
- Market penetration of direct-acting antivirals (DAAs), including Epclusa, exceeds 70% among diagnosed patients.
Key Competitors
- Harvoni (ledipasvir/sofosbuvir)
- Mavyret (glecaprevir/pibrentasvir)
- Vosevi (sofosbuvir/velpatasvir/voxilaprevir)
- Epclusa maintains roughly 25% market share.
Distribution Channels
- Specialty pharmacies account for 80% of distribution.
- Hospital formularies and outpatient clinics account for roughly 15%.
- Online and mail-order pharmacies occupy the remainder.
Prescribing Trends
- Rising identification of asymptomatic cases has increased demand.
- Age demographics show higher prevalence among patients aged 50-65.
- Treatment guidelines continue to favor pan-genotypic agents like Epclusa.
Pricing Overview
Current List Price and Reimbursement
- Average Wholesale Price (AWP): Approximately $24,000 per 28-day supply (per Nov. 2022 data).
- Actual transaction price (negotiated with payers): $12,000–$15,000 per course.
- Insurance coverage: Most plans cover at least 80%, with copay assistance programs reducing patient out-of-pocket costs.
Comparative Pricing
| Drug Name |
Approximate Price (per 28-day course) |
Genotype Coverage |
Approval Year |
| Epclusa |
$24,000 |
1-6 |
2016 |
| Harvoni |
$94,500 |
1,4,5,6 |
2014 |
| Mavyret |
$26,400 |
1-8, including special populations |
2017 |
| Vosevi |
$94,500 |
1-6, with resistance Profile |
2017 |
Price Trends and Projections
- Prices are stabilizing due to increased generic competition in some markets.
- The introduction of generics in key markets like India has led to price declines of up to 60% for some formulations.
- In the U.S., branded drug prices are more resistant to declines but see persistent negotiations and discounts.
Impact of Patent and Patent Expiry
- Epclusa's composition patent expires in 2028 in the U.S.
- Patent lawsuits and patent extensions could alter timing.
- Generic entry expected in late 2020s, potentially decreasing prices by 60-80% in high-income markets.
Market Drivers and Risks
Drivers
- High cure rates (>95%)
- Broad genotype activity
- Favorable safety profile
- Increasing screening programs
Risks
- High current pricing limits access in lower-income markets
- Patent litigation delays generic entry
- Competition from newer agents with simplified regimens (e.g., pangenotypic, shorter duration)
Price Forecasts (2023-2030)
| Year |
Estimated Price Range (per course) |
Notes |
| 2023 |
$12,000–$15,000 |
Negotiated discounts; market saturation |
| 2025 |
$8,000–$12,000 |
Entry of generics in developed markets |
| 2027 |
$4,000–$8,000 |
Increased generic proliferation, patent expiry |
| 2030 |
$2,000–$4,000 |
Dominant generic market; potential further price erosion |
Potential Market Growth
- Post-pandemic, increased screening may boost treated patient numbers by 10-15% annually.
- Aging populations and rising local prevalence in emerging markets drive demand.
- Price reductions may expand access in lower-income countries, boosting global sales volumes.
Key Takeaways
- Epclusa (NDC 50474-0599) is a leading pan-genotypic hepatitis C treatment.
- Current U.S. list prices are around $24,000 per course, but actual transaction prices are lower.
- The market is approaching significant price declines due to patent expirations and generics.
- Demand will remain buoyed by high cure rates and broad genotype activity.
- Price erosion expected to accelerate from 2025 onward, reducing costs by up to 80% by 2030.
FAQs
Q1: When is the patent expiration for Epclusa?
A1: Patent expiry in the U.S. is scheduled for 2028, but legal challenges could alter this timeline.
Q2: Are generics available for Epclusa?
A2: Not yet in most markets; anticipated after patent expiration, mainly in emerging regions.
Q3: How does pricing compare to other hepatitis C drugs?
A3: Epclusa’s list price is comparable or slightly lower than Vosevi and Harvoni but higher than some combination generics in markets with licensed generics.
Q4: What factors influence the actual price paid by payers?
A4: Negotiations, rebates, discounts, patient assistance programs, and contractual terms significantly impact final prices.
Q5: What implications does pricing have on market access?
A5: High prices limit treatment in lower-income countries, but upcoming generic options are expected to improve access globally.
References
[1] U.S. Food and Drug Administration. (2016). FDA approves Epclusa for chronic hepatitis C.
[2] IQVIA. (2022). Market Analysis Report: Hepatitis C Therapies.
[3] SSR Health. (2022). Pharmaceutical Price Trends.
[4] PhRMA. (2022). Drug Patent Expiration Data.
[5] World Health Organization. (2021). Hepatitis C Fact Sheet.
