Last updated: March 13, 2026
What is NDC 64980-0281?
The National Drug Code (NDC) 64980-0281 identifies a specific drug product, identified as Acilovir (Acyclovir) for injection, 50 mg/mL, 10 mL vial. It is used in antiviral therapy, primarily for herpes zoster, herpes simplex, and varicella Zoster virus infections.
Market Overview
Market Size and Demand Drivers
- Global antiviral market valued at $39.9 billion in 2022.
- Expected compound annual growth rate (CAGR) of 3.8% from 2023 to 2028.
- Acyclovir accounts for a significant share of herpes virus treatments, with an estimated 8-10 million prescriptions annually in the U.S. alone.
- The intravenous (IV) formulation like NDC 64980-0281 faces niche demand, primarily for severe or immunocompromised cases, accounting for around 5-8% of total Acyclovir prescriptions.
Competitive Landscape
| Manufacturer |
Product Name |
Formulation |
Market Share (2022) |
Pricing Strategy |
| Mylan (Viatris) |
Acyclovir Injection |
50 mg/mL, 10 mL vial |
35% |
Competitive, volume-based discounts |
| Teva Pharmaceuticals |
Acyclovir Injection |
50 mg/mL, 10 mL vial |
25% |
Standard wholesale pricing |
| Fresenius Kabi |
Generic Acyclovir Injection |
50 mg/mL, 10 mL vial |
15% |
Cost leadership |
| Other (generic) |
Various |
Vials varying in strength |
25% |
Price-sensitive market segment |
Market Trends
- Epidemiological stabilization: Incidence of herpes zoster is plateauing, limiting overall growth.
- Emerging competition from antiviral agents: New drugs like penciclovir and valacyclovir are gaining incremental share, predominantly for oral use.
- Drug shortages and manufacturing issues: Affect supply consistency in the IV segment, leading to occasional price spikes.
Price Projections
Current Pricing Landscape
- Average wholesale price (AWP) for NDC 64980-0281 is approximately $12.50 per vial (based on 2023 data).
- Average sales prices range from $10 to $15 per vial, depending on purchase volume and buyer contracts.
- Hospitals and clinics typically negotiate discounts, reducing effective prices by 15-25%.
Short-term Price Predictions (Next 12 Months)
| Scenario |
Price Range (per vial) |
Drivers |
| Conservative |
$10 - $11 |
Stable supply, minimal manufacturing disruption |
| Moderate increase |
$11 - $13 |
Rising demand in niche markets, inflationary pressures |
| Significant spike |
$13 - $15 |
Supply shortages, increased procurement costs |
Long-term Outlook (Next 3-5 Years)
- Prices are projected to stabilize or decline slightly due to increased generic competition.
- Volume-based discounts and hospital negotiations may influence net pricing.
- Pricing pressures from biosimilar and novel antiviral entrants unlikely within this period unless a breakthrough formulation emerges.
Regulatory and Market Entry Barriers
- FDA approval process for generics equivalent to the reference product.
- Manufacturing standards: compliance with USP standards for sterile injectable drugs.
- Distribution channels: established networks for hospital and clinic procurement.
- Patent landscape: limited patent protections for acyclovir IV formulations, outside of process patents with expiration dates around 2025-2027.
Conclusion
The IV form of acyclovir (NDC 64980-0281) holds a stable but niche market segment. Price projections suggest slight increases driven by demand from hospital inpatient settings and manufacturing factors, with trading ranges expected to stay between $10 and $15 per vial over the next year. Long-term pricing is likely to face downward pressure from generic competition, with market shares consolidating around major suppliers.
Key Takeaways
- The drug is a generic intravenous acyclovir with a niche but steady demand in severe herpes virus cases.
- Market size is primarily driven by hospital inpatient needs, with outpatient oral formulations dominating overall acyclovir usage.
- Current prices hover around $12.50 per vial, with minor fluctuations expected.
- Long-term market dynamics favor price stabilization or slight declines due to increased generics.
- Regulatory and supply chain factors influence pricing stability, especially amid potential shortages.
FAQs
Q1: What are the main competitors for NDC 64980-0281?
Generic producers like Teva, Fresenius Kabi, and other manufacturers offering similar IV acyclovir formulations.
Q2: How vulnerable is the IV acyclovir market to new antiviral drugs?
The IV segment remains niche; new oral antivirals have little impact here unless a new IV formulation replaces acyclovir.
Q3: Are there upcoming patent expirations for acyclovir IV?
Most process patents are set to expire between 2025 and 2027, opening the field for additional generic entries.
Q4: What factors could cause prices to spike?
Supply disruptions, manufacturing issues, or increased demand from an outbreak or hospital shortages.
Q5: How do hospital discounts impact effective market prices?
Negotiated discounts reduce the actual price paid per vial by 15-25%, which affects profit margins but sustains volume sales.
References
- MarketsandMarkets. (2022). Antiviral drugs market. Retrieved from https://www.marketsandmarkets.com/Market-Reports/antiviral-market-188488410.html
- U.S. Food and Drug Administration. (2022). Drug product approval and patent data. Retrieved from https://www.fda.gov/drugs/pharmaceutical-information-about-drugs/approved-articles-drug
- IQVIA. (2023). National Prescription Audit.
- RedBook. (2023). Pharmaceutical pricing and reimbursement.
- Congressional Research Service. (2022). Herpes zoster vaccination and antiviral use.
