Last updated: March 6, 2026
What is the Drug Associated with NDC 58657-0472?
NDC 58657-0472 corresponds to Sofosbuvir-Ledipasvir (Harvoni), a combination antiviral medication developed by Gilead Sciences for the treatment of chronic hepatitis C virus (HCV) infection.
Market Overview
The hepatitis C antiviral market experienced significant growth in the past decade driven by the introduction of direct-acting antivirals (DAAs). Harvoni was first approved by the FDA in October 2014. It became a leading product due to high cure rates and approval for a broad range of HCV genotypes.
Regulatory Status & Indications
- FDA Approval: October 10, 2014
- Indication: Treatment of chronic HCV infection in adults with genotypes 1, 4, 5, and 6
- Strengths: Fixed-dose combination tablet
Market Penetration
Harvoni quickly captured a majority share in the HCV treatment market, exceeding rivals such as Epclusa and Mavyret. However, the market share has been challenged over recent years as generic versions and alternative DAAs entered the market.
Market Size (Historical & Current)
- 2014: The US market for HCV DAAs was approximately $12 billion.
- 2018: Peak market value was around $24 billion globally.
- 2022: The global market declined to approximately $16 billion, reflecting patent expirations and increased competition.
Market projections suggest a continued decline as generics and biosimilars become more prevalent, particularly outside the US.
Price Trends and Projections
Historical Pricing
- Initial US Wholesale Acquisition Cost (WAC): Approximately $94,500 for a 3-month supply
- Price Drop over Time: By 2019, prices in the U.S. dropped to approximately $54,000 per treatment course following negotiations, patent challenges, and rebate programs.
Pricing Drivers
- Patent Expiry: No current patent expiry for Harvoni in major markets, but generics are under development.
- Generics Entry: Countries like India have introduced cheaper generic versions with prices as low as $300 per course.
- Insurance & Rebate Programs: Price discounts and rebates reduce costs for payers.
- Market Competition: Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir) are priced lower, affecting Harvoni’s market share.
Future Price Projections
- Short-term (1-3 years): Moderate decline in list price; actual transaction prices will continue to fall due to negotiations and generics.
- Long-term (3-10 years): Prices could decrease further, approaching $300–$1,000 per course in emerging markets with generics. In developed markets, branded prices may stabilize or slightly decline due to patent protections and market dynamics.
Factors Impacting Future Pricing
- Patent litigation outcomes
- Regulatory approvals of biosimilars and generics
- Payer policies and formulary placements
- Clinical guidelines shifting towards shorter or pangenotypic regimens
Competitive Landscape
| Product |
Status |
Price Range (US) |
Market Share (2022) |
Key Features |
| Harvoni |
Market leader (pre-2020) |
$54,000–$94,500 |
Declined from >80% |
High efficacy, broad genotype coverage |
| Epclusa |
Competitor |
$74,760 |
15% |
Pangenotypic, once-daily dosing |
| Mavyret |
Lower-cost alternative |
$26,400 |
5% |
Shorter treatment, broad genotypes |
Key Market Trends
- Increased competition from generics reduces prices and market share for branded Harvoni.
- Pangenotypic regimens are favored in guidelines, impacting demand for genotype-specific drugs.
- Pricing pressure will continue, especially outside North America.
Actionable Insights
- Patent expiration or licensing outcomes could significantly affect pricing.
- Cost-effectiveness analyses favor newer, broader-spectrum DAAs, putting downward pressure on Harvoni’s price.
- Geographic expansion of generics will further diminish prices globally.
Key Takeaways
- Harvoni remains a key product for Gilead but faces declining market share due to generic competition.
- Prices have decreased significantly from initial launch levels, and further reductions are expected.
- The global HCV market is shifting towards lower-cost, pangenotypic therapies, impacting the future profitability of Harvoni.
- The emergence of biosimilars and patent challenges will influence pricing trajectories.
- Market dynamics favor broad-spectrum, shorter-course regimens over genotype-specific treatments.
FAQs
1. When is Harvoni expected to face patent expiration?
Harvoni’s patent in the US is slated to expire around 2030, though patent challenges and litigation may influence this timeline.
2. How affordable are generic versions of Harvoni?
In India and other markets, generics are priced as low as $300–$600 per treatment course, a fraction of U.S. list prices.
3. Will price reductions impact Gilead’s profitability?
Yes, as prices decline and generic competitors enter, Gilead’s revenue from Harvoni is expected to decrease, unless offset by increased market penetration or new indications.
4. Which markets are most accessible for generic versions?
India, Egypt, and South Africa have the most accessible markets for low-cost generics due to local manufacturing and patent statuses.
5. Are there upcoming alternatives that could replace Harvoni?
Yes, pangenotypic regimens like Epclusa and Mavyret are gaining favor for their flexibility and lower costs, potentially replacing Harvoni in many treatment settings.
References
- U.S. Food and Drug Administration. (2014). Harvoni approval announcement.
- IQVIA. (2022). Global hepatitis C antiviral drug market analysis.
- Gilead Sciences. (2023). Annual report and pipeline updates.
- World Health Organization. (2022). Hepatitis C guidelines.
- MarketWatch. (2023). Top market trends in hepatitis C therapies.
