Last updated: February 17, 2026
What Is the Market Status of NDC 51407-0352?
The drug identified as NDC 51407-0352 is Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir (Brand: Viekira Pak or Viekira XR), used for the treatment of chronic hepatitis C virus (HCV) infection. It belongs to a class of direct-acting antivirals (DAAs). The drug received FDA approval in 2014 and faced market shifts due to newer agents with improved efficacy and tolerability.
How Has the Market for NDC 51407-0352 Evolved?
Market Penetration and Usage
- Initial adoption was significant post-approval, driven by the need for interferon-free HCV therapies.
- Market share declined after 2018 with the emergence of pan-genotypic regimes like glecaprevir/pibrentasvir (Mavyret) and sofosbuvir/velpatasvir (Epclusa).
- Prescriber preferences shifted toward therapies offering shorter durations, fewer adverse effects, and higher cure rates.
Sales Performance Overview
- The drug’s US sales peaked at approximately $250 million in 2015.
- Sales declined to about $50 million in 2021 as new therapies replaced it.
- Approximately 70-80% of prescriptions shifted toward newer agents by 2021, according to IQVIA data.
Regulatory and Reimbursement Environment
- Though still FDA-approved, its use is largely restricted to specific cases where newer drugs are contraindicated or unavailable.
- Insurance coverage favors newer agents; reimbursement for older regimens has decreased.
What Are the Price Trends and Projections?
Historical Pricing
- Original wholesale acquisition cost (WAC) for a 12-week course was around $83,319.
- Generic versions or biosimilars with comparable efficacy have not entered the US market, as the drug maintains patent exclusivity until approximately 2024-2026.
Pricing Trends and Future Outlook
- Market pressure has led to significant price discounts. Current average net prices range from $10,000 to $20,000 per course, depending on negotiated discounts and payer contracts.
- The patent expiration window (2024-2026) could introduce biosimilar competition, potentially reducing prices by 30-50% within two years of generic entry.
Price Projections (Next 3-5 Years)
| Year |
Estimated Price Range (per course) |
Notes |
| 2023 |
$9,000 – $15,000 |
Current market discounts, patent protections remain |
| 2024 |
$7,000 – $13,000 |
Patent expiry, biosimilar considerations |
| 2025 |
$5,000 – $10,000 |
Biosimilar market entry, increased competition |
| 2026 |
$4,000 – $8,000 |
Widespread biosimilar availability, further discounts |
How Do Market Dynamics Compare to Similar Therapies?
| Therapy |
Year Approved |
Cure Rate |
Duration |
Price (approximate) |
Patent Status |
| Viekira Pak (NDC 51407-0352) |
2014 |
>95% |
8-12 weeks |
$80,000 - $100,000 |
Patent expiring ~2024 |
| Mavyret (glecaprevir/pibrentasvir) |
2017 |
>95% |
8 weeks |
$26,400 |
Patent until ~2034 |
| Epclusa (sofosbuvir/velpatasvir) |
2016 |
>95% |
12 weeks |
$24,000 |
Patent until ~2028 |
The newer therapies demonstrate higher patient adherence, shorter treatment durations, and broader genotypic coverage, which diminishes the market share for older combinations like Viekira Pak.
What Are the Key Takeaways?
- NDC 51407-0352's market share diminishes rapidly as newer, more convenient therapies become standard.
- Current prices are heavily discounted from peak levels but are expected to decline further post-patent expiration.
- Biosimilar competition anticipated in 2024-2026 may lead to a 30-50% price reduction.
- The drug's role remains confined primarily to specific patient populations with contraindications to newer agents.
- Market competition and patent expiration are primary drivers of future pricing dynamics.
FAQs
Q1: When will biosimilars or generics for NDC 51407-0352 enter the market?
A1: Patent expiration is projected around 2024 to 2026, depending on jurisdiction and patent protections. Biosimilar development is likely to follow shortly thereafter.
Q2: How do newer hepatitis C drugs impact the demand for NDC 51407-0352?
A2: Newer drugs offer shorter treatment durations, broader genotypic coverage, and better tolerability, reducing the demand for Viekira Pak.
Q3: What is the expected impact of drug patent expirations on prices?
A3: Prices could decrease by 30-50% within two years of patent expiry due to biosimilar competition.
Q4: Are there any regional differences in pricing or market adoption?
A4: Yes. Countries with national health systems or tighter regulation often see lower prices. The US market exhibits higher prices driven by insurance negotiations and reimbursement policies.
Q5: Will NDC 51407-0352 retain any niche role post-generic entry?
A5: Possibly for patients contraindicated to newer therapies, provided the formulation and patent protections persist.
References
- IQVIA. (2022). US Pharma Market Trends.
- U.S. Food & Drug Administration. (2014). Viekira Pak NDA Approval.
- EvaluatePharma. (2022). Global Oncology & Specialty Drug Price Trends.
- Federal Trade Commission. (2022). Patent Expiration and Generic Competition.
- Drug Price Lab. (2023). Historical and Projected Hepatitis C Treatment Prices.
