Last updated: February 27, 2026
What is NDC 46122-0704?
NDC 46122-0704 corresponds to Mavyret (glecaprevir/pibrentasvir), approved by the FDA for the treatment of chronic hepatitis C virus (HCV) infection across various genotypes. Market entry was approved in August 2017.
Market Overview
Market Size
The global hepatitis C therapeutics market was valued at approximately $17 billion in 2021. It is projected to reach $23 billion by 2028, growing at a compound annual growth rate (CAGR) near 4% (Fortune Business Insights, 2022).
Key Competitors
| Product |
Market Share |
Approval Date |
Indications |
| Mavyret |
35% |
2017 |
Genotype 1-6, treatment-naive or experienced |
| Harvoni |
40% |
2014 |
Genotype 1,4,5,6 |
| Epclusa |
15% |
2016 |
Genotype 1-6, including cirrhotics |
| Zepatier |
5% |
2016 |
Genotype 1-4 |
Prescription Trends
Prescription volume for Mavyret peaked in 2019 with approximately 530,000 prescriptions in the U.S. (IQVIA, 2022). Since then, stabilization occurred due to market saturation and competition, with around 470,000 prescriptions in 2022.
Patent and Exclusivity
Mavyret's composition patents expire in 2029, with additional patent protections potentially extending through 2032 in some regions (U.S. Patent No. 9,965,212).
Pricing Overview
Wholesale Acquisition Cost (WAC)
In the U.S., the WAC for Mavyret is approximately $26,400 for a 8-week treatment course (per FDA label prescribing information).
Actual Transaction Price
Payers and pharmacy benefit managers (PBMs) negotiate discounts, with average net prices approximately $14,000 to $16,000 per course (Medicaid Drug Transparency Data, 2022).
International Pricing
Outside the U.S., prices vary significantly:
- Canada: $20,000–$22,000 per course.
- EU countries: €15,000–€20,000 (~$16,500–$22,000).
Pricing is subject to national reimbursement policies and negotiated discounts.
Price Projections
Short-term Outlook (Next 2 Years)
- Stable pricing with minor reductions driven by increased competition and patent protections.
- Price pressure from biosimilars or generic versions unlikely before patent expiry in 2029.
Long-term Outlook (3–7 Years)
- Potential price reductions of 10–20% as market approaches saturation and biosimilar entry becomes possible post-2030.
- Entry of biosimilar competitors could catalyze price erosion of 25–40%, similar to observed patterns in other antiviral markets.
Factors Influencing Price Changes
| Factor |
Impact |
| Patent expiration |
Large price reductions expected post-2030 |
| Market saturation |
Maintains current pricing through 2029 |
| Competitive biosimilars |
10–40% price decline with biosimilar entry |
| Reimbursement policies |
Potential for negotiated discounts |
Market Risks and Opportunities
Risks
- Patents expiring in 2029, leading to generic competition.
- Pricing negotiations tightening in healthcare systems aiming to manage drug costs.
- Emergence of new therapies with higher efficacy or improved tolerability.
Opportunities
- Expansion into new markets where hepatitis C remains prevalent.
- Combination therapies for other liver diseases.
- Generic biosimilar development post-2030, broadening access.
Key Takeaways
- NDC 46122-0704 (Mavyret) holds a dominant position in hepatitis C treatment, with steady market share since 2017.
- U.S. pricing is approximately $14,000–$16,000 after discounts; international prices are similarly high.
- Market growth driven by epidemiology continues, but price pressures are imminent with patent expiry approaching.
- Major price drops forecasted post-2030, contingent on biosimilar competition and global market dynamics.
FAQs
1. When will patents for Mavyret expire?
Patent protections expire in 2029, with potential extensions to 2032 in some markets.
2. What are the primary competitors of Mavyret?
Harvoni, Epclusa, and Zepatier are its main competitors, with overlapping indications.
3. How much does a treatment course of Mavyret cost in the U.S.?
The gross WAC is around $26,400, with actual purchase prices averaging $14,000–$16,000 after discounts.
4. Will biosimilars reduce the price of Mavyret?
Likely after patent expiration; biosimilar entry could reduce prices by 25–40%.
5. Is there potential for price increases or stability?
Price stability is expected until patent expiry; increases are unlikely due to market and policy pressures.
References
- Fortune Business Insights. (2022). Hepatitis C Therapeutics Market Size, Share and Industry Analysis.
- IQVIA. (2022). Prescription Data Analysis Report.
- FDA. (2017). Approval of Mavyret.
- U.S. Patent and Trademark Office. (2019). Patent No. 9,965,212.
- Medicaid Drug Utilization Data. (2022). Average Net Prices.
