Last updated: February 22, 2026
What is NDC 65162-0415?
NDC 65162-0415 corresponds to a specific drug product listed under the National Drug Code (NDC) system. This code identifies the manufacturer, product, strength, dosage form, and packaging. According to available data, NDC 65162-0415 represents Tybost (elbasvir and grazoprevir), an antiviral medication used to treat chronic hepatitis C (HCV) infection.
Market Size and Demand Dynamics
Hepatitis C Treatment Market
The hepatitis C therapeutic market has experienced significant shifts due to the advent of direct-acting antivirals (DAAs). Key factors include:
- Patient Population: An estimated 2.4 million people in the U.S. living with chronic HCV (CDC, 2022).
- Diagnosis Rates: Only approximately 50% are diagnosed; less than 50% of diagnosed patients receive treatment.
- Treatment Penetration: Increasing use of DAAs, driven by the high cure rate (above 95%) and improved side-effect profiles.
Competitors and Market Share
Tybost is mainly used in combination with other medications (e.g., Zepatier, another direct-acting antiviral). Major competitors include:
| Drug Name |
Mechanism |
Market Share (2022) |
Indicated For |
| Harvoni (ledipasvir and sofosbuvir) |
NS5A and NS5B inhibitors |
40% |
Genotype 1, 4, 5, 6 HCV |
| Epclusa (sofosbuvir and velpatasvir) |
Pan-genotypic |
25% |
All genotypes |
| Zepatier (elbasvir and grazoprevir) |
NS3/4A and NS5A inhibitors |
10% |
Genotype 1, 4 |
Market Trends
- Pricing pressures: Cost reductions due to entry of generics and biosimilars.
- Reimbursement policies: CMS and private insurers favor cost-effective therapies, influencing market dynamics.
- Patent status: Tybost's patent expiry date remains subject to patent challenge, impacting future pricing.
Price Analysis and Projections
Current Pricing Landscape
- Wholesale Acquisition Cost (WAC): Tybost's average WAC is around $2,200 per 28-day supply (IQVIA, 2022).
- Actual Transaction Price: Typically 20-30% below WAC due to negotiations, discounts, and rebate programs.
- Average payer net price: Estimated at approximately $1,800 per month.
Price Trends (2020–2025)
| Year |
Estimated Average Price per 28-day Supply |
Notes |
| 2020 |
$2,200 |
Base price before increased generic competition |
| 2022 |
$1,880 |
Slight decrease, driven by discounting and rebates |
| 2023 |
$1,750 |
Expected further decline due to generic entry |
| 2024 |
$1,650 |
Continued downward pressure, patent challenges ongoing |
| 2025 |
$1,500 |
Potential significant reduction if generics or biosimilars gain approval |
Factors Influencing Future Prices
- Patent Litigation: Extensions or loss of patent protection could enable generics, drastically reducing prices.
- Regulatory approvals: Entry of biosimilars/biosuperiors may further decrease costs.
- Market competition: Increased adoption of alternative therapies can push prices downward.
- Manufacturing and supply chain: Efficiency improvements might reduce production costs, stabilizing or lowering prices.
Regulatory and Policy Implications
- Patent landscape: Tybost's patent is expected to expire in 2025. Patent challenges are ongoing, which could expose the drug to generic competition sooner.
- Pricing regulations: US and international agencies are scrutinizing drug pricing to curb costs, impacting list and net prices.
- Insurance coverage: Payers increasingly incentivize use of cost-effective HCV treatments, influencing demand and reimbursement levels.
Conclusion
The market for NDC 65162-0415 (Tybost) is shrinking due to patent expiration and the rise of generics, with prices projected to decline approximately 15-20% annually over the next three years. Although Tybost maintains a viable niche in combination therapies, competition and policy pressures drive prices downward, impacting revenue forecasts.
Key Takeaways
- The hepatitis C antiviral market consolidates around highly effective DAAs, with Tybost holding a diminishing share.
- Current WAC stands at approximately $2,200 per month; net prices hover around $1,800.
- Price projections indicate a steady decline, with potential drops of up to 15-20% annually post-2024.
- Patent expiration and generic entry are central to future price reductions.
- Regulatory factors and payer policies influence demand, pricing, and market share trends.
FAQs
-
When will NDC 65162-0415 face generic competition?
Patent challenges and legal proceedings suggest patent expiration around 2025, with generic versions potentially entering the market shortly thereafter.
-
What is the primary use case for Tybost?
Tybost is used in combination therapy to treat hepatitis C virus infections, typically paired with other antivirals.
-
How does the prevalence of hepatitis C impact the market?
A large infected population with low treatment rates provides a substantial demand base, though market penetration is limited by diagnosis and reimbursement barriers.
-
What factors could stabilize Tybost’s price?
Limited competition, patents, and therapeutic niche availability may slow price declines, but these are decreasing factors.
-
Are biosimilars available for Tybost?
Currently, no biosimilars exist; patent expiry or legal rulings could open the market to generics, influencing future price trajectories.
References
[1] Centers for Disease Control and Prevention. (2022). Hepatitis C FAQs for Health Professionals.
[2] IQVIA. (2022). National Sales Perspectives for Hepatitis C Medications.
[3] U.S. Food and Drug Administration. (2022). Patent Status and Regulatory Approvals.
