Last updated: March 9, 2026
What is NDC 62135-0433?
NDC 62135-0433 corresponds to Odefsey, a prescription medication used for HIV-1 infection. It combines doravirine, lamivudine, and tenofovir disoproxil fumarate. The drug is marketed by Gilead Sciences.
Market Overview
Industry Context
Odefsey is a widely prescribed antiretroviral therapy (ART) for HIV. The global HIV market size was valued at approximately $25 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4% from 2023 to 2030 (Grand View Research, 2023).
Competitive Landscape
The drug faces competition from other fixed-dose combinations (FDCs) such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), Descovy (emtricitabine/tenofovir alafenamide), and Truvada (emtricitabine/TDF). Market share dominance varies based on efficacy, tolerability, and pricing.
Prevalence and Demand
Approximately 38 million people globally live with HIV. In the U.S., an estimated 1.2 million individuals are diagnosed, with around 85% on ART. The chronic nature of HIV requires sustained therapy, underpinning consistent demand for drugs like Odefsey (CDC, 2022).
Regulatory Approvals
Odefsey received FDA approval in 2016. Its label approvals extend to many countries, supporting broad accessibility.
Pricing Landscape
Current Price Point (United States)
- Average Wholesale Price (AWP): Approximately $2,500–$2,800 per month (IQVIA, 2022).
- List Price: Ranges from $2,200 to $2,600 monthly.
- Actual Transaction Price (insurers, PBMs): Likely significantly lower due to rebates and negotiations.
Pricing Trends
Over the past five years, the sticker price for Odefsey has remained relatively stable, with minor increases reflecting inflation and market dynamics. Price discounts, rebates, and patent protections influence actual consumer and payer costs.
Reimbursement and Market Access
Reimbursement rates heavily depend on formulary status and negotiated discounts. Generic versions are not available currently, maintaining a patent-protected pricing advantage.
Market Projections (2023–2030)
Revenue Forecasts
| Year |
Estimated Market Revenue (USD billions) |
Assumptions |
| 2023 |
1.5 |
Steady demand, no significant price changes |
| 2024 |
1.55 |
Slight market share increase due to new patients |
| 2025 |
1.6 |
Competitive pressures rising, stable demand |
| 2026 |
1.65 |
Introduction of second-generation therapies |
| 2027 |
1.75 |
Growth due to expanded indications or regional growth |
| 2028 |
1.8 |
Patent protection maintains pricing stability |
| 2029 |
1.85 |
Market penetration in emerging regions |
| 2030 |
1.9 |
Potential patent expiry leading to generic competition |
Price Trajectory
- Short-term (2023–2025): Prices likely remain stable, with minor inflation adjustments.
- Mid-term (2026–2028): Potential slight decline if generic or biosimilar versions emerge, or if market competition intensifies.
- Long-term (2029–2030): Prices may decrease by 10–20% if patent protections expire, leading to biosimilar entries.
Risks & Opportunities
Risks
- Patent expiration in 2028 may induce significant price erosion.
- Market entry of generics or biosimilars.
- Changes in treatment guidelines favoring alternative therapies.
Opportunities
- Expansion into emerging markets.
- Combination therapy innovations.
- Price negotiations with payers yielding volume growth.
Key Takeaways
- The current market price in the U.S. averages around $2,200–$2,600 per month.
- Revenue projections suggest gradual growth, limited by competitive forces.
- Patent protections sustain pricing; expiry could lead to price declines by 2028.
- Future expansion into lower-income markets could drive volume but may pressure margins.
- The ongoing landscape depends heavily on regulatory decisions, patent status, and competition.
FAQs
1. What factors influence the price of NDC 62135-0433?
Pricing is affected by manufacturing costs, patent status, market competition, negotiations with payers, and regional market dynamics.
2. How might patent expiry impact the drug’s price?
Patent expiry, expected around 2028, can lead to generic entry, resulting in a 50–80% price reduction depending on market dynamics.
3. What are the main competitors to Odefsey?
Biktarvy, Descovy, and Truvada are primary competitors, each with differing efficacy and pricing profiles.
4. Is there potential for price reduction through biosimilars?
While biosimilars are more common for biologics, affordable generics of components (like tenofovir or lamivudine) could reduce overall therapy costs.
5. What strategies could sustain revenue beyond patent expiration?
Strategies include oral patent extensions, developing new formulations, expanding indications, and entering emerging markets.
References
[1] CDC. (2022). HIV Basics. Centers for Disease Control and Prevention.
[2] Grand View Research. (2023). HIV Market Size & Forecast.
[3] IQVIA. (2022). International Data on Drug Pricing.
