Last updated: February 25, 2026
What is NDC 00904-6506?
The drug NDC 00904-6506 is Sofosbuvir, marketed as Sovaldi, used for treating hepatitis C virus (HCV) infection. It became available in 2013 and is a nucleotide polymerase inhibitor that targets HCV replication.
Market Overview
Market Size and Patient Population
- Global hepatitis C prevalence: Approximately 58 million individuals (WHO, 2022).
- U.S. diagnosed population: 2.7 million (CDC, 2022).
- Treatment penetration: Estimated 50–60% of diagnosed patients receive therapy.
- Market segments:
- Chronic HCV patients eligible for direct-acting antivirals (DAAs)
- Treatment-naïve versus treatment-experienced patients
- Different genotypes (mainly genotypes 1-3)
Market Dynamics
- Competitive landscape:
- Multiple direct-acting antivirals: Harvoni (Ledipasvir/Sofosbuvir), Epclusa (Velpatasvir/Sofosbuvir), Mavyret (Glecaprevir/Pibrentasvir).
- Sofosbuvir's market share has decreased as newer, pan-genotypic therapies entered the market.
- Pricing trends:
- Initial list price for Sovaldi was $84,000 per 12-week course.
- Discounts and negotiations have brought prices down to an estimated $26,000–$31,000 per course in the U.S.
- Global prices vary widely, with lower prices in emerging markets.
Market Trends and Drivers
- Treatment guidelines: Recommend early treatment, increasing demand.
- Patent exclusivity: Patents expired or are nearing expiration in various markets, leading to potential generic competition post-2023.
- Access programs: Insurance coverage and Medicaid programs influence market share and revenue.
Price Projections
Short-term (Next 1-2 Years)
- Price stabilization: Domestic prices likely remain in the $26,000–$31,000 range, driven by negotiated discounts.
- Generic entry impact:
- India’s patents for sofosbuvir expired in 2022.
- Generic versions are available at approximately 10–20% of brand price.
- Significant price erosion anticipated in markets receptive to generics.
Medium-term (3-5 Years)
- Market share shifts:
- Generics expected to capture 40–60% of the market outside the U.S.
- Brand sales decline proportionally.
- Price reductions:
- As generic competition intensifies, branded drug prices likely decrease further.
- Projected median price per course: $15,000–$20,000.
- Impact of new therapies:
- Introduction of pan-genotypic, shorter-duration regimens may reduce demand for older formulations.
Long-term (5+ Years)
- Market contraction:
- With increased generic use and generic pricing, revenue from branded Sovaldi will decline sharply.
- Potential for price stabilization at low levels:
- In low-income and emerging markets, prices could stabilize around $5,000–$10,000 per treatment course.
Regulatory and Patent Outlook
| Year |
Patent Expiry |
Generic Approvals |
Market Impact |
| 2022 |
2022 (India) |
Multiple generics launched |
Major price erosion in India and similar markets |
| 2024 |
2024 (U.S.) |
Anticipated patent challenges |
Potential for limited generic sales |
References
- World Health Organization. (2022). Global hepatitis report. WHO.
- Centers for Disease Control and Prevention. (2022). Hepatitis C data and surveillance. CDC.
- IQVIA. (2023). Global Pharmaceutical Market Data.
- U.S. Food and Drug Administration. (2022). List of approved drugs, including patent status.
- IMS Health. (2022). Market trends for hepatitis C treatments.
Key Takeaways
- The market for sofosbuvir (NDC 00904-6506) peaked soon after its launch, with existing strong demand for HCV treatment.
- Prices have declined due to negotiations, discounts, and generic competition, especially in countries where patents expired recently.
- The entry of generics and new therapies will drive prices down further, especially outside the U.S., with revenue likely to decrease substantially over the next five years.
- Long-term prospects focus on low-cost generics in emerging markets, with branded sales diminishing gradually.
FAQs
1. When did patent expiration for sofosbuvir occur in major markets?
India’s patent expired in 2022; U.S. patent expiration is anticipated in 2024.
2. How does generic competition affect sofosbuvir pricing?
Generics reduce prices by 80–90%, making treatment more accessible but decreasing revenue for brand manufacturers.
3. What are the alternative therapies impacting sofosbuvir’s market?
Pan-genotypic, shorter-duration treatments such as Mavyret and Vosevi, which compete on efficacy and cost.
4. Will branded sofosbuvir regain market share?
Unlikely; patent expirations and generic entry limit potential for market rebound.
5. How do treatment guidelines influence future demand?
Updated guidelines favor early, broad treatment with pan-genotypic agents, potentially reducing the demand for older formulations like exclusive sofosbuvir.
Citations
[1] WHO. (2022). Global hepatitis report. World Health Organization.
[2] CDC. (2022). Hepatitis C data and surveillance. Centers for Disease Control and Prevention.
[3] IQVIA. (2023). Global pharmaceutical market data.
[4] FDA. (2022). Approved drug list. U.S. Food and Drug Administration.
[5] IMS Health. (2022). Market trends for hepatitis C treatments.
