Last updated: February 13, 2026
What is the drug associated with NDC 82009-0143?
The NDC 82009-0143 corresponds to Sovaldi (sofosbuvir) 400 mg tablets. It is an antiviral medication used primarily for hepatitis C virus (HCV) infection treatment.
How large is the market for Sovaldi (sofosbuvir)?
Market size overview
- Global hepatitis C market was valued at approximately USD 13.1 billion in 2022.
- The U.S. market accounts for nearly 50% of this, with estimated revenue of USD 6.5 billion.
- The prevalence of hepatitis C in the U.S. is around 2.4 million chronic cases (CDC, 2022).
Key drivers
- Expansion of screening programs increases diagnosed cases.
- Newer direct-acting antivirals (DAAs) maintain a significant share.
- Patent exclusivity constraints influence pricing and market penetration.
Competitive landscape
Generics entered the market starting 2019, reducing prices but maintaining a premium for branded Sovaldi in some regions due to patent protections.
What are the current pricing trends?
List price versus actual transaction prices
| Descriptor |
Approximate List Price per 28-day supply |
Average Contract Price (U.S.) |
Discount Factors |
| Branded (Sovaldi) |
USD 24,000 |
USD 10,000 – 15,000 |
Up to 60% off |
| Generic (post-patent) |
USD 1,000 – 2,000 |
USD 300 – 600 |
Up to 85% off |
Influencers of pricing
- Patent status:
Sovaldi’s patent expiry in the U.S. is in 2029, allowing generics.
- Reimbursement policies:
Coverage varies with payer policies, influencing net prices.
- Market access programs:
Negotiations and discounts for Medicaid, commercial insurers, and hospital systems.
What are the price projections?
Short-term outlook (2023–2025)
- Stable or declining prices due to increased generic penetration.
- Brand price erosion expected as patents expire; potential discounts for formulations bundled with other DAAs.
- Partnered pricing models: Manufacturers negotiating volume-based discounts.
Long-term outlook (2026–2030)
- Further price declines anticipated as competition intensifies.
- Potential price stabilization at lower levels, around USD 300–600 per course.
- Market consolidation could influence pricing, especially if new combination therapies emerge.
Forecasting assumptions
- Continued patent protections until 2029.
- Uptake influenced by approval of alternative treatments.
- Regulatory changes favoring biosimilars or generics.
Comparative analysis with similar drugs
| Drug |
Year of Approval |
Initial Price (USD) |
Current Price Range |
Patent Expiry |
| Harvoni |
2014 |
USD 94,500 (12-week course) |
USD 35,000 – 50,000 |
2028 (pending biosimilar entry) |
| Epclusa |
2016 |
USD 74,760 |
USD 25,000 – 40,000 |
2030 (patent) |
Key considerations for stakeholders
- Manufacturers should focus on patent enforcement and lifecycle management.
- Payers are adopting strict formulary restrictions to control costs.
- Investors may see price declines but benefit from high-volume sales before patent expiry.
Key Takeaways
- The market for hepatitis C treatments remains sizable, driven by global prevalence.
- Branded Sovaldi is priced significantly higher than generic options, with discounts applied based on payer negotiations.
- Prices are projected to decline steadily through the next five years, especially after patent expiration.
- Competition from generics will likely reduce average prices, impacting revenue streams for the originator.
- Future pricing will depend on patent status, regulatory developments, and market uptake of combination therapies.
Frequently Asked Questions
1. When does patent protection for Sovaldi expire?
In the U.S., patent protections are expected to extend to 2029, allowing generic entry afterward.
2. What are the main factors influencing the decline in drug prices?
Patent expiration, increased generic competition, payer negotiations, and regulatory policies.
3. How do current prices compare internationally?
European and Asian prices generally are lower, often between USD 10,000 and USD 20,000 per course, influenced by pricing regulations.
4. Are there any upcoming legal or policy changes that could affect pricing?
Potential biosimilar and generic approvals, patent litigation outcomes, and healthcare policy reforms could influence prices.
5. What are the implications for investors in hepatitis C drugs?
Short-term revenues remain substantial; future declines in prices after 2029 are expected, emphasizing the importance of patent management and pipeline development.
Sources
[1] Centers for Disease Control and Prevention (CDC), 2022. "Hepatitis C FAQs for Health Professionals"
[2] IQVIA, 2022. "Global Medicine Spending and Usage Trends"
[3] EvaluatePharma, 2023. "Pharmaceutical Market Intelligence Data"
[4] U.S. Patent and Trademark Office, 2023. "Patent Expiry Data for Hepatitis C Treatments"
[5] GoodRx, 2023. "Current Pricing and Discounts for Hepatitis C Medications"
