Last updated: February 22, 2026
What is the drug identified by NDC 00480-7067?
NDC 00480-7067 corresponds to Atripla, a fixed-dose combination product containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate. It is approved for the treatment of HIV-1 infection.
Market Overview
Current Market Size
- The global HIV therapeutics market was valued at approximately $24.5 billion in 2022.
- The United States accounts for about 55% of this market, reflecting high drug adoption rates.
- Atripla's approximate sales revenue in 2022 was $1.2 billion, representing a significant share of branded antiretroviral therapies.
Competitive Landscape
- Key competitors include Biktarvy (Gilead), Descovy (Gilead), and Dovato (ViiV Healthcare).
- Generic equivalents of efavirenz, emtricitabine, and tenofovir are available, pressuring long-term drug pricing.
Regulatory Status & Patent Landscape
- Approved in 2006, patent protections have primarily expired or are close to expiry; Gilead holds the original patent rights.
- Patent expirations expected from 2024–2026, opening space for generics.
Price Trends
Current Pricing
| Package Size |
Approximate Wholesale Price (WAC) |
Estimated Retail Price |
| 30-day supply (30 tablets) |
$2,600 |
$3,200 |
Note: Prices vary by region and pharmacy discounts.
Historical Price Changes
- Since approval, prices remained stable until patent expiry approaches.
- In 2018, introduction of generics in Europe led to price reductions of approximately 30%.
Future Price Projections
Factors Influencing Future Pricing
- Entry of generics expected between 2024–2026 following patent expiration.
- Increased competition typically reduces prices by 50–80% over five years post-generic entry.
- Continued patent protections or exclusivity extensions are unlikely, given regulatory trends and patent challenges.
Projected Price Range (2024–2030)
| Year |
Expected Wholesale Price Range |
Notes |
| 2024 |
$1,200 – $1,500 |
Patent expiry initiates generic entry. |
| 2025 |
$600 – $900 |
Price declines with increasing generic options. |
| 2026 |
$400 – $700 |
Market stabilizes; generics dominate. |
| 2027–2030 |
$300 – $500 |
Generics establish widespread adoption. |
Market Dynamics and Key Trends
- Generic Competition: Will substantially drive down prices post-2024.
- Demand Stability: Persistent need for HIV treatment sustains demand despite price declines.
- Policy Impacts: Medicaid, Medicare, and insurance negotiations influence actual end-user prices.
Investment and R&D Implications
- Patent expiration opens avenues for generic manufacturers.
- Innovator companies may pursue formulations with improved efficacy or safety to extend lifecycle.
- Market entry barriers for generics include regulatory approval timelines and patent litigation.
Summary of Price Evolution
| Year |
Approximate Price (Wholesale) |
Percentage decrease from 2023 levels |
| 2023 |
$2,600 |
— |
| 2024 |
$1,200 – $1,500 |
42–54% |
| 2025 |
$600 – $900 |
65–73% |
| 2026 |
$400 – $700 |
75–85% |
Key Takeaways
- NDC 00480-7067 (Atripla) faces significant pricing pressure due to imminent patent expirations.
- Generics are expected to reduce prices by up to 80% within five years of market entry.
- Market demand remains stable due to ongoing HIV treatment needs.
- Competitive dynamics will shape future pricing and market share distribution.
FAQs
1. When will generics likely enter the market for NDC 00480-7067?
Generics could enter as early as 2024, depending on patent litigation outcomes and approval processes.
2. How will patent expiration affect the market?
Patent expiration will allow generic manufacturers to produce lower-cost alternatives, significantly reducing prices.
3. Are there potential regulatory hurdles for generics?
Yes, including necessary bioequivalence studies and patent challenges that could delay entry.
4. What is the projected price decline for Atripla post-generic entry?
Prices could decline by 50–80% over five years after generics become available.
5. How does competition impact the branded drug's sales?
Increased generic competition reduces sales volume and revenue for the branded product but sustains demand for the drug class.
References
[1] IQVIA. (2023). Global HIV market report.
[2] Gilead Sciences. (2022). Annual report on HIV/AIDS therapies.
[3] U.S. Patent and Trademark Office. (2022). Patent expiration timelines.
[4] Medtech Insights. (2023). Pricing trends in antiretroviral drugs.
