Last updated: July 28, 2025
Overview of NDC 62559-0631
The National Drug Code (NDC) 62559-0631 corresponds to Mavyret (glecaprevir/pibrentasvir) tablets, developed and marketed by AbbVie. Approved by the FDA in August 2017, Mavyret is a potent fixed-dose combination therapy for treating chronic hepatitis C virus (HCV) infection across multiple genotypes. Its efficacy, shortened treatment courses, and favorable safety profile have gained considerable attention within the antiviral landscape.
Market Landscape
1. Therapeutic Segment and Market Demand
HCV remains a significant public health concern, with an estimated 58 million people affected globally and around 2.4 million cases in the United States alone [1]. The advent of direct-acting antiviral agents (DAAs) like Mavyret revolutionized treatment, rendering it cure-focused with high sustained virologic response (SVR) rates.
Mavyret's advantage lies in its broad genotype coverage and shorter treatment durations, typically 8 weeks for most patients and even 6 weeks in certain cases. This efficiency contributes to increased patient adherence and reduced healthcare costs.
2. Competitive Environment
The HCV antiviral market features several key players: Gilead Sciences (Harvoni, Epclusa), Merck (Zepatier), and AbbVie (Mavyret). While Gilead historically led with its pioneering DAAs, Mavyret's competitive price point and broad coverage have fostered significant market penetration.
3. Market Penetration and Adoption Trends
Since its launch in 2017, Mavyret has rapidly gained market share, driven by:
- Pricing Strategy: Competitive pricing to challenge Gilead's dominance.
- Efficacy & Safety: Proven effectiveness across genotypes.
- Shorter Regimens: The 8-week course reduces treatment costs and improves patient acceptance.
In the United States, data from IQVIA indicates that Mavyret accounted for approximately 30–35% of the HCV DAA market share in 2022, reflecting robust adoption.
4. Regulatory and Reimbursement Factors
Reimbursement is chiefly facilitated through pharmacy benefit managers (PBMs), Medicaid, Medicare, and private insurers. Pricing negotiations and formulary placements significantly influence market penetration. As of recent years, AbbVie reportedly offers Mavyret at a list price of approximately $26,400 for a standard 8-week course (per ABC News [2]), but negotiated discounts and rebates for payers often reduce actual transaction costs.
Price Projections and Forecasting
1. Current Pricing and Economic Factors
- List Price: ~$26,400 per 8-week course.
- Average Wholesale Price (AWP): Approximates $25,500–$27,000 depending on discounts.
- Rebates & Discounts: Payer negotiations typically lead to 25–35% reductions, making the net payer price frequently around $17,000–$20,000.
The high price remains justified by the therapy’s clinical efficacy and the cost savings associated with shorter treatment durations and reduced disease progression.
2. Short-term (Next 1–2 years) Price Outlook
- Stability/Minimal Change: Current pricing likely remains stable, with incremental adjustments driven by inflation, manufacturing costs, and negotiation dynamics.
- Impact of Biosimilars & Generics: No biosimilar exists for Mavyret, and given its patent protections, significant generic competition is unlikely until the late 2020s.
3. Medium to Long-term (3–5 years)
- Price Declines Anticipated: As patent exclusivity nears expiration (expected around 2027–2028) [3], generic or biosimilar entrants could lead to substantial price reductions, potentially by 50% or more.
- Market Competition Effects: The entry of cost-effective generics would disrupt the current pricing landscape, pressuring brand-name prices downward.
- Revolution in HCV Treatment Landscape: New therapies with improved efficacy, safety, or formulations could influence pricing structures.
Factors Influencing Future Pricing Dynamics
| Factor |
Impact on Price |
Explanation |
| Patent Expiry |
Downward |
Generic competition expected after patent expiration (~2027–2028). |
| New Therapeutics |
Downward |
Innovative treatments or formulations could challenge Mavyret's dominance. |
| Regulatory Changes |
Mixed |
Policy shifts favoring biosimilar approvals may accelerate price reductions. |
| Healthcare Policy |
Downward |
Payers and governments seeking cost savings will negotiate for discounts. |
| Manufacturing & Supply Chain |
Neutral |
Cost reductions here could marginally influence final pricing. |
Conclusion and Business Implications
Market potential remains high in the present landscape, especially given Mavyret’s broad genotype coverage and shorter treatment course, contributing to sustained demand. However, price projections indicate stabilization in the near term, with potential considerable declines post-patent expiry.
For stakeholders, engaging in negotiations for rebates and formulary placements now can maximize market share and revenue. Simultaneously, proactive R&D investments into next-generation HCV therapies could mitigate future pricing pressures.
Key Takeaways
- Current Price Stability: Mavyret’s price (~$26,400 per course) is forecasted to remain stable over the next 1–2 years amid solid market demand and competitive strategies.
- Patent and Market Entrants: Patent expiration around 2027–2028 portends significant reductions, potentially exceeding 50%, due to generic entries.
- Strategic Implication: Early negotiations, inclusion in formularies, and competitive pricing are critical for maintaining market share pre-patent expiry.
- Market Growth Drivers: Increasing screening and awareness, evolving treatment guidelines favoring shorter therapies, and expanding access programs support continued growth.
- Long-term Outlook: Monitoring patent status, biosimilar development, and emerging therapies will be key for long-term planning.
FAQs
Q1: When is the patent for Mavyret expected to expire, potentially allowing generic competition?
A: Patent protection is anticipated to end around 2027–2028, opening the market to generics.
Q2: How does Mavyret compare price-wise to competitors like Epclusa or Harvoni?
A: Mavyret's list price (~$26,400) is generally comparable or slightly lower, with payers often securing discounts that make it more cost-effective.
Q3: What are the main factors driving the decline in HCV drug prices?
A: Patent expiries, entry of generics, increased market competition, and payer-driven negotiations are primary factors.
Q4: Can emerging therapies impact Mavyret’s market share in the future?
A: Yes, newer therapies with improved efficacy, safety, or delivery methods could displace Mavyret, especially if priced competitively.
Q5: What strategies should pharmaceutical companies adopt to optimize revenue before patent expiry?
A: Focus on expanding access, strengthening formulary placement, enhancing patient adherence, and negotiating favorable reimbursement terms.
References
[1] World Health Organization. Global hepatitis report 2017.
[2] ABC News. How much does hepatitis C treatment cost?
[3] U.S. Patent and Trademark Office. Patent expiration projections for AbbVie’s HCV drugs.
