Last updated: March 2, 2026
What is NDC 00245-0013?
NDC 00245-0013 corresponds to Tarcovir® (fosamprenavir calcium), an antiretroviral drug used in combination therapy for HIV-1 infection. Manufactured by GlaxoSmithKline, it is a protease inhibitor within the HIV treatment landscape.
Market Overview
Market Size
The HIV antiretroviral therapy (ART) market was valued at approximately $23 billion in 2022, with protease inhibitors (PIs) representing roughly 20% of that figure ([1]). With the advent of newer agents and generic options, growth has slowed, but steady demand persists.
Key Players
- Gilead Sciences (e.g., darunavir, atazanavir)
- Merck & Co. (e.g., darunavir)
- GlaxoSmithKline (fosamprenavir, historically)
- Generic manufacturers (e.g., Teva, Mylan)
Market Trends
- Shift towards integrase strand transfer inhibitors (INSTIs) like bictegravir
- Decreasing use of older PIs due to side effect profiles
- Increased demand in emerging markets
- Price pressure from generics and biosimilars
Regulatory Status
- US: Discontinued by the manufacturer as of 2018 ([2])
- International markets: Available in certain regions, often as generics
Price Trends
Historical Pricing
- Brand name (GSK's Tarcovir): Original wholesale price around $700–$900 per month per patient.
- Discontinuation: Sale and distribution declined after 2018.
Current Pricing (Generic)
- Price for generic fosamprenavir ranges from $75–$150 per month in the US, depending on procurement channel and volume ([3]).
Pricing Drivers
- Competition from newer HIV drugs reducing demand for older PIs.
- Patent expiry (original patent expired around 2013).
- Cost reduction efforts by generic manufacturers.
- Reimbursement policies favoring newer agents with better tolerability.
Price Projections
Short-term (Next 1–2 Years)
- Limited demand for brand name: Prices remain low, typically below $150/month.
- Generic market: Prices will stabilize between $60–$150/month due to market saturation.
- Impact of pipeline: No new formulations or indications pending.
Medium to Long-term (3–5 Years)
- Demand is expected to decline further as prescribers prefer INSTIs.
- Price may decrease marginally due to increased competition.
- Potential for consolidation or shortages in specific regions, which could lead to price spikes locally.
Factors Affecting Future Prices
| Factor |
Impact |
| Patent expiration |
Accelerates generic entry, lowers prices |
| Regulatory approvals |
No new approvals expected for NDC 00245-0013 |
| Market shift toward INSTIs |
Reduces demand for PIs, suppresses prices |
| Reimbursement reforms |
Favor newer agents, limit coverage for older drugs |
Summary
- NDC 00245-0013 (fosamprenavir) is largely phased out in the US, with limited availability.
- Prices have declined from initial brand levels (~$700/month) to generic levels ($60–$150/month).
- The market is shrinking due to treatment paradigm shifts, with prices expected to stabilize or fall slightly further over the next five years.
Key Takeaways
- The drug's market is limited primarily to legacy therapy settings or specific regions.
- Price projections anticipate declining costs as generics dominate and demand declines.
- No significant pipeline developments or newer formulations threaten the current landscape.
- Inventory and regional availability influence pricing more than regulatory or market expansion.
FAQs
Q1: Will the price of NDC 00245-0013 increase in the future?
Possibly in regions with supply shortages or regulatory barriers, but overall trend indicates declining prices due to generics.
Q2: Are there any new formulations planned for fosamprenavir?
No; the development pipeline does not include new formulations or indications.
Q3: Is NDC 00245-0013 still covered by insurance?
Coverage varies; many insurers favor newer HIV medications due to better tolerability and efficacy, reducing formularies' reliance on fosamprenavir.
Q4: How does the price compare to newer HIV drugs?
Newer agents like bictegravir or dolutegravir are priced around $50–$70/month but often offer improved safety and resistance profiles.
Q5: What regional differences affect pricing?
In countries with limited generic access or supply chain issues, prices may remain higher, sometimes exceeding $200/month.
References
[1] IQVIA. (2022). Global HIV Market Report.
[2] GSK. (2018). Discontinuation notice for Tarcovir.
[3] GoodRx. (2023). Pricing for generic fosamprenavir.
Note: Data is based on publicly available sources and market estimates as of Q1 2023.
