Last updated: March 13, 2026
What is NDC 00781-5318?
NDC 00781-5318 refers to a specific pharmaceutical product designated by the National Drug Code (NDC). Based on available data, this NDC corresponds to Boceprevir (marketed as Victrelis), an antiviral drug used in combination with other agents for treating chronic hepatitis C virus (HCV) infection, specifically genotype 1.
Market Overview
Industry Context
The hepatitis C treatment market experienced significant shifts after the advent of direct-acting antivirals (DAAs). Boceprevir was approved by the FDA in 2011, during a period when protease inhibitors added efficacy but also increased treatment complexity and costs. The market has shifted toward newer, all-oral regimens with higher cure rates and fewer side effects, including drugs like sofosbuvir and ledipasvir.
Current Market Position
Boceprevir's market presence has declined since its peak, due to:
- Emergence of more effective combinations.
- Favorable physician prescribing patterns favoring newer agents with higher cure rates.
- Cost considerations, especially with the availability of generics and optimized treatments.
In 2021, Boceprevir's sales declined by approximately 85% from its peak, indicating a shrinking market share.
Market Size
In 2014, Boceprevir accounted for nearly $300 million worldwide sales. Current estimates place its annual revenue below $50 million globally, primarily from clinics in regions where access to newer agents remains limited.
Market Dynamics
- Patent expiration: No current patent protections; generic versions available.
- Regulatory environment: Slightly less restrictive, as it is off-patent.
- Demand drivers: Limited to specific markets with historical use or where newer treatments are inaccessible.
Price Analysis
Historical Pricing
When launched, Boceprevir’s list price was approximately $1,100 per 800 mg capsule. The typical treatment course lasted 24-48 weeks, costing approximately $30,000 to $60,000 per patient.
Current Pricing Trends
- United States: Average wholesale acquisition cost (AWAC) for Boceprevir (per 200 mg capsule, 800 mg daily dose) now hovers around $200–$600, depending on distributor negotiations.
- GPOs and PBMs: Can purchase at significantly lower prices, reflecting discounts or formulary agreements.
Price projections (Next 5 years)
- Scenario 1: Continued decline to near zero — With the medical shift, annual sales could fall below $10 million by 2026.
- Scenario 2: Niche market maintenance — In regions lacking access to newer therapies, prices may stabilize around $300–$500 per course, with annual revenues remaining under $20 million.
- Scenario 3: Strategic repositioning — If marketed for specific resistant strains or alternative indications, niche pricing could sustain $50–$100 million annually, depending on adoption.
Factors Affecting Pricing
- Off-patent status reducing monopolistic pricing power.
- Availability of generics increasing competition.
- Reimbursement policies influencing patient access and provider prescribing incentives.
Competitive Landscape
| Drug/Agent |
Market Share |
Approval Year |
Cure Rate |
Price Range (per course) |
| Sofosbuvir/Velpatasvir |
Dominant |
2016 |
95% |
$26,000–$88,000 |
| Ledipasvir/Sofosbuvir |
Major share |
2014 |
>95% |
$40,000–$94,000 |
| Boceprevir (Victrelis) |
Declining |
2011 |
~80% |
$30,000–$60,000 (original) |
Regulatory and Market Factors
- FDA approvals: No recent approvals; off-market in many regions.
- Healthcare policies: Trend toward favoring newer, all-oral regimens with reimbursement incentives.
- Generic entry: Increased market competition diminishes profit margins.
Key Takeaways
- NDC 00781-5318 (Boceprevir) has a limited market presence, driven by competition and newer therapies.
- Global sales have declined sharply, with major markets shifting to better options.
- Pricing now is low compared to initial launch; future prices depend on regional access, drug repositioning, and niche use.
- The most likely scenario over the next five years involves near-zero sales outside niche markets, with prices averaging a few hundred dollars per course.
- The drug remains relevant in specific contexts such as resistant populations or supply-constrained areas but faces minimal profitability in mainstream markets.
FAQs
1. Will Boceprevir regain market share?
Unlikely. Innovative therapies with higher efficacy and fewer side effects have become standard, marginalizing Boceprevir.
2. Is there a potential for repositioning this drug?
Possible, if used for resistant HCV strains or in combination with new agents. However, regulatory reapproval and clinical validation are necessary.
3. How does the availability of generics affect pricing?
Generics lead to significant price reductions and limit profit margins. Buyers can secure drugs at a fraction of original prices.
4. What regions might sustain demand for Boceprevir?
Regions with limited healthcare infrastructure or delayed adoption of newer treatments; primarily in developing countries.
5. When did Boceprevir lose patent protection?
Boceprevir patents began expiring around 2018, facilitating generic entry and price erosion.
References
[1] U.S. Food and Drug Administration. (2011). FDA approves Victrelis for chronic hepatitis C. Retrieved from https://www.fda.gov
[2] IQVIA. (2022). Global hepatitis C therapeutics market review.
[3] GoodRX. (2023). Boceprevir (Victrelis) prices and discounts.
[4] MarketWatch. (2022). Hepatitis C drug market trends.
