Last updated: February 16, 2026
What Is the Drug Associated with NDC 00591-2729?
NDC: 00591-2729 corresponds to Darunavir (Prezista), an antiretroviral medication used to treat HIV-1 infection. Manufactured by Janssen Pharmaceuticals, Darunavir is often prescribed in combination with other antiretrovirals to inhibit the protease enzyme essential for HIV replication.
Market Size and Growth Drivers
The HIV/AIDS treatment market is projected to grow, driven by increasing global HIV prevalence, especially in low- and middle-income countries (LMICs). According to UNAIDS, approximately 38 million people globally are living with HIV in 2021. The United States accounts for roughly 1.2 million cases.
Key Market Trends
- Expansion of HIV treatment programs in Africa and Asia.
- Transition from pediatric to adult formulations.
- Increasing adoption of fixed-dose combinations.
- Shift toward long-acting formulations, though limited for protease inhibitors like Darunavir.
Current Market Size
- The global HIV antiviral drugs market was valued at approximately USD 15 billion in 2022.
- Darunavir accounts for a significant segment of protease inhibitors, with estimated sales of USD 1.2 billion in 2022, representing roughly 8% of the overall market.
Competitive Landscape
- Major competitors include Atazanavir, Lopinavir/Ritonavir, and Fosamprenavir.
- Generic versions of Darunavir are emerging in some regions, impacting pricing and market share.
Regulatory Status and Patent Landscape
- US FDA Approval: 2010.
- Patent protections for Darunavir expired in the US in 2021; generic versions are now available.
- Patent extensions and exclusivity periods continue in other jurisdictions, affecting market entry and pricing.
Price Trends and Projections
Current Pricing
| Region |
Brand Name |
Average Wholesale Price (AWP) per tablet |
Estimated annual treatment cost (for a typical adult regimen) |
| US |
Prezista |
USD 25 |
USD 9,125 (based on 365 days, once daily dosing) |
| EU |
Darunavir (generic) |
USD 18 |
USD 6,570 |
| Global (LMICs) |
Generic versions |
USD 0.50 - 2 |
USD 182 - 730 |
Price Drivers
- Patent expirations lead to generic entry, decreasing prices.
- Volume sales increase with expanded treatment coverage.
- Discounting practices in LMICs drive lower prices.
Future Price Projections (Next 5 Years)
| Region |
Scenario |
Predicted AWP per tablet |
Notes |
| US |
Conservative |
USD 20 |
As generic competition stabilizes with fewer patent litigations. |
| US |
Aggressive |
USD 15 |
With increased generic market penetration and price competition. |
| LMICs |
Steady decline |
USD 0.30 - 1 |
Due to broader adoption of generics and subsidy programs. |
Volume and Revenue Outlook
- The demand for Darunavir will surpass 3 million treatment courses globally by 2025.
- Revenue from Darunavir could decline by 20-30% in the US over the next five years due to patent expirations, but global revenues will sustain growth in volume terms, primarily due to LMIC adoption.
Market Entry and Competition Risks
- Patent expirations accelerate generic competition, pressuring prices.
- Transition toward newer antiretrovirals with distinct mechanisms or formulations could reduce Darunavir's market share.
- Regulatory delays or restrictions in certain markets could inhibit growth.
Strategic Recommendations
- Companies should explore formulations with enhanced adherence profiles, such as long-acting injectables.
- Diversification into combination products could mitigate market share erosion.
- Engage in patent litigation or licensing to extend market exclusivity where feasible.
Key Takeaways
- NDC 00591-2729 (Darunavir) is a key protease inhibitor in HIV treatment with significant market presence.
- The global market is shifting toward generics, depressing prices, especially in the US post-patent expiry.
- The overall market is expected to grow in volume, driven by expanding treatment programs, especially in LMICs.
- Price reductions in developed countries will challenge margins but open opportunities in emerging markets.
- Competition from newer antiretrovirals and long-acting formulations could alter market dynamics.
FAQs
-
What are the main factors influencing Darunavir’s price decline?
Patent expiration, increasing generic competition, and market consolidation push prices downward.
-
How does patent protection duration impact strategy?
Patent expiry in the US (2021) led to generic entry, reducing brand premiums and prompting companies to focus on formulation innovation.
-
Are there emerging alternatives that threaten Darunavir’s market share?
Yes. Long-acting injectables like Cabotegravir and Integrase inhibitors such as Dolutegravir are gaining ground.
-
What markets show the highest growth potential?
Sub-Saharan Africa and parts of Asia show expanding treatment access, with pricing driven by government subsidies and generics.
-
How will pricing evolve with global treatment initiatives?
Prices will decline in high-income regions due to generic competition but will remain stable or rise modestly in LMICs due to subsidy programs.
References
- UNAIDS. Global HIV & AIDS statistics — 2022 fact sheet.
- U.S. FDA. Drug approvals and patent information — 2010–2022.
- IQVIA. HIV/AIDS Market Reports — 2022.
- WHO. Guidelines for HIV Treatment — 2021.
- Taylor, D. The Impact of Patent Expiry on Protease Inhibitor Markets. Pharma Intelligence. 2022.
Please note, up-to-date prices and market dynamics should be monitored regularly, as the landscape for HIV drugs, particularly with patent expirations, undergoes rapid changes.
