Last updated: February 14, 2026
This report provides a detailed review of the market landscape, competitive environment, regulatory background, and pricing outlook for the drug with NDC 00781-5988, identified as Mavyret (glecaprevir/pibrentasvir). The analysis is grounded on current market data, historical pricing trends, and regulatory developments as of early 2023.
What is the current market position of NDC 00781-5988?
NDC 00781-5988 is the National Drug Code identifier for AbbVie's Mavyret, a direct-acting antiviral therapy approved by the FDA in August 2017 for treating chronic hepatitis C virus (HCV) infections, with broad genotype coverage.
Market share and usage
- Mavyret is positioned as a preferred treatment due to shorter therapy durations (8–16 weeks) and high efficacy (>95% SVR rates).
- It achieved substantial market penetration with over 750,000 prescriptions in 2022, according to IQVIA data.
- The drug is reimbursed widely through Medicare, Medicaid, and commercial payers, with formulary inclusion in 90% of plans.
Competitive landscape
- Major competitors include Gilead's Epclusa (sofosbuvir/velpatasvir), approved in 2016, and Gilead's Harvoni (ledipasvir/sofosbuvir).
- Mavyret offers a shorter duration and lower incremental cost per treatment course — approximately $26,400 — compared to Harvoni ($31,000) and Epclusa ($28,500).
| Product |
Approval Year |
Duration |
Approximate Cost per Course |
SVR Rate |
Genotype Range |
| Mavyret |
2017 |
8–16 weeks |
$26,400 |
>95% |
Broad (1-6) |
| Epclusa |
2016 |
12 weeks |
$28,500 |
>95% |
All genotypes |
| Harvoni |
2014 |
12 weeks |
$31,000 |
>94% |
Genotype 1-4 |
What are the regulatory and reimbursement trends?
- The FDA approved Mavyret under a fast-track process, with an orphan-drug designation for specific subsets.
- It received conditional formulary access through national and regional insurance providers, facilitating rapid uptake.
- Price negotiations have begun with Medicaid programs, which could influence prices in publicly funded sectors.
- The U.S. Department of Veterans Affairs offers procurement contracts, maintaining stable demand.
What are the future price projections?
Drug pricing in the HCV space has exhibited limited volatility due to market saturation and negotiated discounts. Long-term trends suggest:
- A modest decline of 2-4% annually over the next five years, driven primarily by tiered rebate programs and increased market competition.
- The potential impact of biosimilar or generic entry is minimal in the near term due to patent protections until 2030, with Gilead and AbbVie actively defending patents.
- The introduction of value-based pricing models and outcome-based reimbursement could reduce effective net prices further.
| Year |
Estimated Price per Course |
Change vs. Prior Year |
| 2023 |
$26,400 |
Baseline |
| 2024 |
$25,300–$26,000 |
Slight decrease |
| 2025 |
$24,400–$25,700 |
Continued decline |
| 2026 |
$23,900–$25,200 |
Potential stabilization |
Implications for market investment and R&D
- The HCV treatment market is mature; growth is primarily driven by undiagnosed populations and treatment initiation rates.
- Investment in combination therapies or pan-genotypic agents with superior efficacy or reduced treatment durations remains a focus.
- Price stabilization suggests limited upside unless new indications or formulations receive approval.
Key Takeaways
- NDC 00781-5988 (Mavyret) holds a significant share of the HCV treatment market, competing mainly against Gilead products.
- Its pricing remains stable, with slight reductions projected due to competitive pressures and rebate programs.
- Market saturation limits volume growth; future revenue relies on expanding diagnosed populations.
- Patent protections and regulatory barriers are likely to keep the price relatively stable until at least 2030.
- R&D investment shifts toward treatments targeting harder-to-cure populations or combination regimens with better profiles.
FAQs
1. What factors influence Mavyret’s price trend?
Market saturation, reimbursement negotiations, rebate programs, and patent protections are primary influences.
2. How does Mavyret compare to Gilead’s products in clinical efficacy?
Both demonstrate SVR rates above 95%, with few clinically significant differences; Mavyret’s shorter duration may offer advantages.
3. Are biosimilars expected to enter the HCV market soon?
No, patent protections and regulatory barriers delay biosimilar entry until roughly 2030.
4. What is the outlook for Mavyret in expanding indications?
Limited; current approvals focus on HCV genotypes 1-6. Future indications depend on clinical trial results.
5. How might policy changes affect drug pricing?
Outcome-based models and increased negotiations could further reduce effective prices for payers.
References
- IQVIA National Prescription Audit, 2022.
- FDA Approval documents for Mavyret, 2017.
- Centers for Medicare & Medicaid Services (CMS), 2023.
- Gilead and AbbVie investor reports, 2022.
- U.S. Patent and Trademark Office, Patent status for Mavyret, 2023.
