Last updated: February 17, 2026
Overview:
NDC 45802-0139 is a prescription drug marketed under the brand name Raltegravir, used for the treatment of HIV-1 infection. As a medication classified as an antiretroviral, it plays a vital role in managing HIV/AIDS. The drug’s market size, competitive landscape, and pricing trends are shaped by patent status, generic entry, usage patterns, and pricing policies.
Current Market Status:
Raltegravir was approved by the FDA in 2007. It is manufactured by Merck & Co., which held exclusive rights until the expiration of its patent. Since patent expiration around 2020, multiple generic versions entered the US market, increasing competition.
- Market Size: The global HIV drug market is estimated at $29 billion in 2022, with North America contributing roughly 50% ($14.5 billion). Raltegravir accounts for approximately 8-10% of the HIV antiretroviral segment, translating to a market size of roughly $2.3 billion annually.
- Market Share: Prior to patent expiry, Merck held about 80% market share for raltegravir. Generics now capture 60%-70% of the US market due to widespread availability and lower prices.
Pricing Trends:
- Branded Raltegravir (Isentress): The average wholesale price (AWP) was approximately $2,250 per 30-day supply (2019). Post-generic entry, prices declined substantially.
- Generic Versions: Current AWP prices for generic raltegravir range from $600 to $900 per 30-day supply, depending on supplier and formulation.
| Price Factor |
Pre-Patent Expiry (Brand) |
Post-Patent Expiry (Generics) |
| Average wholesale price (per 30-day) |
~$2,250 |
$600 – $900 |
| Price reduction after generics entry |
N/A |
60-70% decrease |
| Average patient copay (estimated) |
$50 – $200 |
$10 – $50 |
Price Projection Outlook:
| Year |
Estimated Price Range (per 30-day supply) |
Key Factors |
| 2023 |
$600 – $900 |
Full generic market penetration |
| 2024 |
$500 – $850 |
Increased generic competition, possible further price declines |
| 2025 |
$400 – $800 |
Market saturation, potential biosimilar entry or price stabilization |
| 2030 |
$350 – $750 |
Potential patent extensions or formulations with improved delivery |
Factors Influencing Future Prices:
- Patent and Exclusivity: The original patent expired in 2020; any secondary patents or exclusivities could temporarily sustain higher prices.
- Generic Competition: Increased number of manufacturers tends to stabilize prices downward.
- Pricing Policies: US Medicaid and Medicare drug reimbursement policies could influence retail and pharmacy billing.
- Biospecific Formulations: New formulations with improved dosing or delivery could alter price trends.
- Market Dynamics: Competition from other drugs within the HIV therapeutic class influences pricing and market share.
Regulatory and Reimbursement Policies Impact:
Federal programs, like Medicaid and Medicare, negotiate drug prices and cap copays, accelerating price declines for generic formulations. The Affordable Care Act and subsequent legislation aim to reduce drug prices, which could further pressure prices downward.
Competitive Landscape:
The entry of generics lowered costs but also fragmented market share. Major competitors include Teva, Mylan, and Sun Pharma, each offering bioequivalent formulations at lower prices.
Supply Chain and Distribution:
- Wholesale distributors primarily set pricing benchmarks.
- PBMs and insurance companies negotiate rebates, further affecting net prices.
- International markets often have lower prices due to different pricing regulations and healthcare systems.
Key Takeaways:
- Market share shifted significantly post-generic entry in 2020.
- Prices for generic raltegravir now range between $600–$900 per 30-day supply, reflecting a 60-70% decline from branded prices.
- Forecasts project prices could stabilize around $350–$750 by 2030, contingent on regulatory, patent, and market dynamics.
- The HIV drug market remains competitive, with generics dominating pricing, while branded versions hold limited niche or specialty value.
- Reimbursement policies and healthcare reforms will likely continue to pressure prices downward over the next decade.
FAQs
1. How does patent expiration affect drug pricing?
Patent expiration allows generic manufacturers to enter the market, increasing competition, which drives prices down significantly.
2. Are there biosimilar or alternative formulations of raltegravir?
No biosimilars or alternative formulations are currently approved for raltegravir; price declines are primarily due to generics.
3. What factors influence variation in generic drug prices?
Number of manufacturers, production costs, supply chain dynamics, and pricing negotiations with payers determine the variation.
4. How do policies like Medicaid rebates impact drug prices?
Rebates negotiated by Medicaid and PBMs reduce net prices paid by insurers and healthcare programs, indirectly affecting retail pricing.
5. Will branded raltegravir regain market share?
Unlikely, unless new formulations or indications are developed that provide added clinical benefits.
References:
[1] IQVIA. "The Use of HIV Drugs in the United States." 2022.
[2] FDA. "Pharmaceutical Approvals and Patents for Raltegravir." 2020.
[3] GoodRx. "Raltegravir (Brand vs. Generic Prices)." 2023.
[4] Mordor Intelligence. "HIV Drugs Market Forecast." 2022.
