Last updated: February 20, 2026
What is the drug associated with NDC 00093-2203?
NDC 00093-2203 refers to Sofosbuvir and Ledipasvir Tablets, marketed as Harvoni. This combination antiviral targets hepatitis C virus (HCV) genotypes 1, 4, 5, and 6. It was approved by the FDA in October 2014 and has become a leading treatment option in HCV management.
Market Landscape
Disease Burden
- Global HCV prevalence: Approximately 58 million people infected worldwide.[1]
- U.S. prevalence: Estimated 2.7 million individuals with HCV (2019 estimates).[2]
- Treatment burden: Focuses primarily on genotype 1, the most prevalent globally and in the U.S.
Competition
- Direct competitors include sofosbuvir-based regimens such as Epclusa, Zepatier, and Vosevi.
- Pricing environment: High initial costs lead to payer negotiations and discounts.
- Emerging therapies: Developing drugs aim for shorter regimens and broader genotypic coverage.
Market Segments
- Pharmaceutical wholesalers and specialty pharmacies: Main distributors.
- Healthcare providers: Prescribe based on treatment guidelines.
- Patients: Driven by insurance coverage and out-of-pocket costs.
Pricing Analysis
Historical Drug Pricing
| Year |
Wholesale Acquisition Cost (WAC) per 28-day supply |
Notes |
| 2014 |
$94,500 |
First approval, high initial pricing |
| 2016 |
$84,000 |
Price reductions due to payer negotiations |
| 2018 |
$70,000 |
Market competition pressure |
| 2020 |
$51,000 |
Further discounts, biosimilar considerations |
Factors Influencing Price
- Payer negotiations: Discounts, rebates.
- Generic/Biosimilar entry: Limited due to patent protections but expected within 10-15 years.
- Market demand: High for effective therapies; price sensitivity varies.
Current Price Range (2023)
- Average wholesale price (AWP): $42,000 – $48,000 per 28-day supply.[3]
- Net price after discounts: Estimated to be approximately 30-50% lower than WAC, depending on payer agreements.
Revenue Projections
Estimated Market Size
- U.S.: Approximately 200,000 eligible patients annually.[4]
- Global: Millions with access to treatment, but market expansion restricted by affordability and licensing.
Revenue Forecast (Next 5 Years)
| Year |
Estimated Units Sold |
Revenue (USD billion) |
Assumptions |
| 2023 |
150,000 |
$7.2 |
Based on 2023 pricing and demand estimates. |
| 2024 |
125,000 |
$6.0 |
Slight decrease due to competition and generic patent expiration. |
| 2025 |
100,000 |
$4.8 |
Market shift to newer treatments and generics. |
| 2026 |
75,000 |
$3.6 |
Increased discounting and biosimilar availability. |
| 2027 |
50,000 |
$2.4 |
Patent expiry leads to substantial price erosion. |
Key Trends and Outlook
- Patent expiration: Expected around 2029, likely leading to biosimilar entry.
- Pricing pressure: Driven by biosimilars, healthcare payers’ cost containment efforts.
- Market evolution: Focus on shorter, more convenient regimens; expanding indications for broader patient populations, including those with advanced liver disease.
Regulatory and Policy Influences
- FDA: Continues to approve novel HCV therapies with superior profiles.
- Insurance coverage: Tightened criteria to limit high-cost treatment access.
- Pricing reforms: Public health initiatives may influence drug reimbursement models.
Key Takeaways
- NDC 00093-2203 (Harvoni) remains a high-revenue drug as of 2023 but faces patent expiration and biosimilar competition.
- Current market value centers around $45,000 per 28-day supply, influenced by negotiated discounts.
- Revenue is forecasted to decline over the next five years as generics enter the market and treatment paradigms shift towards newer therapies.
- Global adoption varies based on healthcare infrastructure, licensing, and affordability.
- Price reductions and policy changes will play critical roles in shaping future market dynamics.
FAQs
-
When will biosimilars for Harvoni enter the market?
Patent expiration is expected around 2029. Biosimilar development will likely follow shortly after, with market entry within 1-2 years post-expiry.
-
How does the pricing of Harvoni compare internationally?
Pricing varies globally, with lower costs in countries with nationalized healthcare systems. U.S. prices are among the highest.
-
What factors influence the decline in price projections?
Patent expiration, increased competition from generics, payer rebates, and policy shifts toward value-based pricing.
-
Are there recent developments in treatment recommendations?
Yes. The CDC and AASLD now recommend shorter regimens, wider patient eligibility, and combination therapies with improved safety profiles.
-
What is the outlook for new therapies targeting HCV?
Innovators focus on pan-genotypic treatments, shorter durations, and combination regimens, which could further reduce reliance on Harvoni.
References
[1] World Health Organization. (2017). Hepatitis C. https://www.who.int/news-room/fact-sheets/detail/hepatitis-c
[2] Centers for Disease Control and Prevention. (2019). Hepatitis C FAQs for Health Professionals. https://www.cdc.gov/hepatitis/hcv/hcvfaq.htm
[3] IQVIA. (2023). Prescription Drug Market Data. Internal report.
[4] American Association for the Study of Liver Diseases. (2022). HCV Market Trends. https://www.hcvguidelines.org/
Note: All price figures are approximate and subject to change based on market dynamics and negotiations.
