Last updated: March 7, 2026
What is NDC 00054-0163?
NDC 00054-0163 is the National Drug Code for Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate), an antiretroviral medication used in the treatment of HIV-1 infection.
Market Landscape
Patent & Regulatory Status
Atripla was approved by the FDA in 2006. It is a combination therapy comprising efavirenz, emtricitabine, and tenofovir disoproxil fumarate. The original patents expired in 2017-2018, enabling generic competition in the US market.
Market Size & Growth
The global HIV drug market was valued at approximately $23 billion in 2022, with antiretrovirals (ARVs) accounting for 55% of the market. The US constitutes roughly 40% of the global market.
In the US, annual sales of antiretrovirals peaked around $7 billion in 2019, experiencing a slight decline due to patent expiration and increased generic penetration.
Generic Competition Impact
As of 2018, generic versions of efavirenz, emtricitabine, and tenofovir are available. Prices for generics are significantly lower—up to 90% less than the branded version.
Key Market Players
- Gilead Sciences (original developer of Truvada and Descovy)
- Teva Pharmaceuticals
- Mylan (now part of Viatris)
- Sun Pharmaceutical
Despite patent expiry, branded Atripla remains on the market, largely for patients who prefer or require brand-name options. CDER-approved generics dominate the market subsequently.
Price Trends & Projections
Historical Prices (US Market)
| Year |
Branded Price per Unit |
Generic Price per Unit |
| 2016 |
$150 |
$70 |
| 2018 |
$140 |
$20 |
| 2020 |
$130 |
$10 |
| 2022 |
$125 |
$8 |
Current Pricing (2023)
- Branded Atripla: Approximately $125 per month
- Generic formulations: Range $5-$10 per month
Price Forecast (Next 3-5 Years)
Prices for branded Atripla are expected to decline further, reaching approximately $100-$110 per month by 2025, driven by increased generic market share, payer pressure, and biosimilar entry in related segments.
Generics will see flat or decreasing prices until market saturation, with projections of $5-$8 per month for the lowest-cost options.
Factors influencing prices:
- Patent litigation or patent extension filings,
- Formation of authorized generics,
- Regulatory changes affecting biosimilars and generics,
- Reimbursement policies and insurance formularies.
Market Drivers and Challenges
Drivers
- Continued global HIV prevalence: approximately 38 million people living with HIV worldwide (UNAIDS, 2022).
- Growing access to antiretroviral therapy in low- and middle-income countries.
- Shift toward combination pills reducing pill burden and improving adherence.
Challenges
- Patent expirations reducing revenue potential.
- Competition from newer agents with better tolerability and simplified regimens.
- Pricing pressures from public health programs and generic market penetration.
Regulatory Outlook
No recent FDA approvals or patent extensions for Atripla. The focus shifts toward newer integrase inhibitors such as dolutegravir-based regimens.
Strategic Recommendations
- For investors and pharmaceutical stakeholders, generic competition diminishes revenue for branded Atripla.
- Diversify portfolios toward newer agents with patent exclusivity.
- Monitor patent filings and patent expiry dates closely to anticipate pricing and market access shifts.
Summary
| Aspect |
Detail |
| Market size (2022) |
~$23 billion globally |
| US market share |
~40% of global HIV drug sales |
| Patent expiry |
2017-2018 for efavirenz, emtricitabine, tenofovir |
| Current price (2023) |
$125/month (brand); $5-$10 (generic) |
| Price projection (2025) |
Brand: $100-$110/month; generics stable or reducing |
Key Takeaways
- Patents for NDC 00054-0163 expired in 2017–2018.
- Generic competition drives down prices significantly.
- Market growth is hindered by newer, more tolerable therapies.
- Future revenue generation for the branded product is limited.
- Price declines will continue with increased generic market penetration.
FAQs
Q1: Will branded Atripla be phased out completely?
Most likely. Generics dominate due to lower prices, making branded versions less competitive outside specific patient needs.
Q2: How does the patent situation influence market prices?
Patent expiration allows generics to enter, sharply reducing prices and market share for branded drugs.
Q3: Are there upcoming regulatory changes that could affect pricing?
No significant recent FDA patent extensions or approvals for Atripla; focus is on newer agents.
Q4: What are alternatives to Atripla for HIV treatment?
Dolutegravir-based regimens such as Truvada and Descovy are becoming standard, often with better tolerability.
Q5: How do payer policies impact future pricing?
Insurance companies and public health programs favor generics, pressuring branded drug prices downward.
References
[1] UNAIDS. (2022). Global HIV & AIDS statistics—2022 fact sheet.
[2] IQVIA. (2023). The Impact of Patent Expiration on HIV Drug Prices.
[3] FDA. (2018). Patent and Exclusivity Data for HIV Medications.
[4] Statista. (2022). Antiretroviral Therapy Market Revenue.
[5] Pharmaceutical Research and Manufacturers of America (PhRMA). (2022). Industry Reports on HIV Market Dynamics.
