Last updated: March 27, 2026
What Is the Drug Identified by NDC 62135-0732?
NDC 62135-0732 corresponds to Epclusa (sofosbuvir and velpatasvir), manufactured by Gilead Sciences. It is an oral antiviral agent approved for treating chronic hepatitis C virus (HCV) infection across genotypes 1 through 6. Approved by the FDA in 2016, Epclusa has become a standard of care for HCV eradication due to its broad efficacy.
Market Landscape
Market Size and Demand
- Prevalence of HCV globally: Approximately 58 million people infected worldwide; roughly 2.4 million in the United States (CDC, 2022).
- Treatment eligibility: Large treatment pool, with about 75% of diagnosed patients eligible for oral direct-acting antiviral (DAA) therapies.
- Market penetration: As of 2022, approximately 1.2 million U.S. patients had been treated with DAAs, with Epclusa accounting for a significant share.
Competitive Position
- Key competitors: Harvoni (ledipasvir/sofosbuvir), Mavyret (glecaprevir/pibrentasvir), Zepatier (elbasvir/grazoprevir).
- Market share: Epclusa has ranked as one of the leading HCV therapies, with a market share exceeding 30% in 2022.
- Patents and exclusivity: Patent protections extend into 2028; generic versions may introduce pricing pressure thereafter.
Treatment Trends
- Growth driven by increasing diagnosis rates and expanding treatment coverage.
- Shift toward shorter treatment durations and improved efficacy.
- Continued emphasis on affordability and access in public health initiatives.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP): Approximately $24,000 to $45,000 for a 12-week course (CMS, 2022).
- Negotiated Medicaid and Medicare prices: Typically lower, in the $20,000 range.
- Real-world cost to patients: Varies based on insurance, assistance programs, and negotiated discounts.
Historical Price Changes
| Year |
Average Price per Course |
Factors Influencing Price |
| 2016 |
$84,000 |
Initial launch price, high innovation premium |
| 2018 |
$45,000 |
Price negotiations, competition emerges |
| 2020 |
$24,000 |
Increased generic penetration, payer pressure |
| 2022 |
$20,000–$25,000 |
Continued competition, manufacturing efficiencies |
Future Price Projections
- Short-term (1-2 years): Prices are expected to remain stable due to patent protections and limited generic competition until 2028.
- Mid-term (3-5 years): Price reductions may occur if biosimilars or generics gained regulatory approval and market penetration increases.
- Factors affecting pricing: Patent expiry, biosimilar approval, healthcare policy shifts, and payer negotiations.
| Scenario |
Expected Price Range |
Likelihood |
Notes |
| Conservative |
$20,000–$25,000 |
High |
Patent protection intact, little generic competition |
| Moderate |
$15,000–$20,000 |
Medium |
Entry of generics post-2028, negotiated discounts increase |
| Optimistic |
<$15,000 |
Low |
Widespread biosimilar approval and reimbursement policies favor lower prices |
Policy and Regulatory Factors
- Medicare and Medicaid have implemented utilization management strategies to control costs.
- The Biden administration’s focus on reducing drug prices may accelerate negotiations and discounts.
- The potential entry of generic formulations after patent expiration could cut market prices by 50% or more.
Supply Chain and Manufacturing Considerations
- Gilead’s manufacturing capacity supports stable supply.
- Entry of generics could reduce manufacturing costs significantly, translating into lower prices.
- Scaling production efficiencies may further decrease prices over time.
Key Takeaways
- NDC 62135-0732 (Epclusa) maintains high demand due to its broad genotype coverage.
- Pricing has declined from initial list prices, aligning with increased market competition and policy pressures.
- Future price reductions are likely after patent expiration in 2028, contingent on generic approvals.
- Market growth is driven by increased screening, diagnosis, and treatment access.
- Manufacturers and payers will need to navigate patent protections, biosimilar approvals, and reimbursement negotiations.
FAQs
Q1. What is the primary driver for future price declines of Epclusa?
Patent expiration and the entry of generic competitors will largely influence future pricing, potentially reducing costs by half or more.
Q2. How does the current price compare to other HCV treatments?
Epclusa's current price is comparable or slightly lower than Harvoni but higher than Mavyret, which offers shorter treatment courses and broader affordability.
Q3. What factors influence negotiations with payers?
Coverage policies, treatment efficacy, competition, and healthcare budget constraints significantly impact negotiated prices with insurers.
Q4. Are there any ongoing policy measures affecting drug pricing?
Yes. Policies aimed at increasing drug price transparency, encouraging biosimilar entry, and negotiating drug prices via Medicare and Medicaid are actively shaping the landscape.
Q5. What are the prospects for biosimilar or generic versions?
Post-2028, biosimilars and generics are expected to challenge brand-name prices, though regulatory and patent hurdles may delay widespread adoption.
References
- Centers for Disease Control and Prevention (CDC). (2022). Hepatitis C FAQs for Health Professionals.
- Centers for Medicare & Medicaid Services (CMS). (2022). National Average Drug Acquisition Cost (NADAC).
- Gilead Sciences. (2022). Epclusa Product Information.
- IQVIA. (2022). National Prescription Audit Data.
- U.S. Food & Drug Administration (FDA). (2016). FDA approves Epclusa for treatment of all chronic hepatitis C genotypes.
