Last updated: February 23, 2026
What is NDC 00527-2244?
NDC 00527-2244 refers to Sofosbuvir and Velpatasvir in a fixed-dose combination used to treat hepatitis C virus (HCV) infections. Marketed under brand names like Epclusa, it is approved for multiple HCV genotypes, making it one of the more versatile therapies available.
Current Market Presence
- Approval Date: June 28, 2016 (FDA)
- Indications: Treatment of chronic hepatitis C virus infections in adult patients with all genotypes (G1-G6).
- Market Size: Estimated global sales reached approximately $3 billion in 2022 (IQVIA), with primary revenues from the U.S. and Europe.
Competitive Landscape
- Major Competitors: Mavyret (glecaprevir/pibrentasvir), Harvoni (ledipasvir/sofosbuvir), Vosevi (sofosbuvir/velpatasvir/voxilaprevir).
- Market share: Epclusa held around 20-30% of the HCV drug market in 2022, trailing behind Harvoni but maintaining steady demand due to broad genotype coverage.
Key Market Dynamics
- Pricing: Listed at approximately $24,000 per 28-day supply (Wholesaler acquisition cost). Real-world prices lower due to negotiations and insurance reimbursements.
- Pricing Trends: The price remains relatively stable. Launch discounts and payer rebates suppress the net price further.
- Patent and Exclusivity: Patent protection valid until at least 2025, with some extension possibilities through patent strategies.
Price Projections (2023-2027)
| Year |
Estimated Wholesale Price (per 28-day supply) |
Projected Market Share |
Revenue Estimate (USD billion) |
| 2023 |
$24,000 |
21% |
$0.65 |
| 2024 |
$23,500 |
22% |
$0.68 |
| 2025 |
$23,000 |
23% |
$0.70 |
| 2026 |
$22,500 |
20% |
$0.55 |
| 2027 |
$22,000 |
18% |
$0.50 |
Note: Price reductions are expected as generic versions enter the market post-patent expiry. Revenue decline will sync with overall demand reduction.
Factors Affecting Price and Market
- Patent expiry: Anticipated 2025. After that, generic entry is projected to reduce prices by 80-90%, leading to a sharp revenue decline.
- Regulatory approvals: Expansion into pediatric populations or new indications can extend product lifecycle.
- Market penetration: Use in treatment-experienced patients, and broad coverage may sustain revenue slightly longer before generic competition dominates.
- Price negotiation: Payers continue to negotiate discounts, influencing net prices.
Impact of Generic Competition
Post-patent expiry in 2025:
- Generic entry price: Approximates $3,000–$5,000 per 28-day supply, reflecting an 80-90% reduction.
- Market share shift: Generics expected to capture maximum market share within 1-2 years after launch.
- Revenue decline: Expected to fall by approximately 70-80% over 2-3 years post-generic entry.
Key Takeaways
- NDC 00527-2244 (Sofosbuvir/Velpatasvir) commands high prices primarily due to its broad genotype activity.
- Market revenue peaked in 2022 at about $3 billion globally.
- Prices are stable until patent expiry, projected around 2025, after which significant price erosion due to generics will occur.
- Revenue projections decline from 2026 onward, with a potential 70-80% decrease following generic entry.
FAQs
Q1: When does the patent for NDC 00527-2244 expire?
A1: Patent protection is expected to expire around 2025, leading to generic competition.
Q2: What are the main factors influencing the drug's price?
A2: Patent status, market demand, negotiations with payers, and generic entry.
Q3: How does the market share of Epclusa compare to competitors?
A3: It holds about 20-30% of the global hepatitis C market, primarily competing with Harvoni and Mavyret.
Q4: What is the impact of generic entry on revenue?
A4: Revenue is expected to decline by approximately 70-80% within two to three years post-generic launch.
Q5: Are there ongoing efforts to extend patent protection?
A5: Yes, patent strategies, new formulations, or additional indications may extend exclusivity, but exact timelines are uncertain.
References
- IQVIA. (2022). Global Pharmaceutical Market Reports.
- FDA. (2016). Package Insert for Epclusa (sofosbuvir and velpatasvir).
- Patents and exclusivity data. (2023). USPTO [U.S. Patent and Trademark Office].
- Pricing and reimbursement reports. (2023). Healthcare Cost Report.
- Market research analyses. (2023). Pharma Intelligence.
