Last updated: February 26, 2026
What is NDC 24385-0006?
NDC 24385-0006 corresponds to Apretude (cabotegravir), a long-acting injectable medication approved by FDA in December 2021 for the prevention of HIV infection in adults and adolescents who weigh at least 35 kg. It is marketed by ViiV Healthcare.
Market Scope and Drivers
Indications and Market Penetration
- Approved for pre-exposure prophylaxis (PrEP) against HIV.
- Provides an alternative to daily oral PrEP regimens like Truvada (tenofovir/emtricitabine).
- Tailored for patients with adherence challenges to daily pills.
Market Size
- Global HIV PrEP market estimated at USD 2-3 billion in 2022.
- U.S. market represents approximately 60-65% of total global spend.
- HIV prevalence in the U.S.: 1.2 million people, with about 25% undiagnosed.
- Estimated patient population eligible for PrEP: 1.1 million in the U.S. (per CDC estimates).
Competitive Landscape
| Drug |
Indication |
Formulation |
Approval Year |
Market Share (2022) |
| Cabotegravir (NDC 24385-0006) |
HIV PrEP |
Injectable (monthly) |
2021 |
45% |
| Truvada |
HIV PrEP |
Oral (daily) |
2012 |
35% |
| Descovy |
HIV PrEP |
Oral (daily) |
2019 |
15% |
| Others |
Post-exposure, treatment |
Various |
Varies |
5% |
Pricing Overview
- Apretude (cabotegravir) list price in the U.S.: approximately USD 3,800 per injection (per dose), with an initial two-shot induction phase and subsequent monthly doses.
- The cost of oral PrEP (e.g., Truvada) averages USD 1,800–2,000 annually, though insurance coverage reduces out-of-pocket expenses.
Reimbursement and Insurance Coverage
- Coverage by Medicare, Medicaid, private payers.
- Manufacturer programs reduce patient costs.
- High per-injection cost limits adoption in some markets without subsidy.
Price Projections and Market Trends
Short-term (2023-2024)
- The price is expected to remain stable at approximately USD 3,800 per dose.
- Moderate growth in market penetration driven by prescriber acceptance, insurance coverage, and patient awareness.
- Estimated 10-15% annual increase in sales volume due to expansion in high-risk populations and new clinics adopting injectable PrEP.
Medium-term (2025-2027)
- Potential price adjustments driven by increased competition and market expansion.
- Likely reduction of net price due to payer negotiations, especially as more cost-effective generics or biosimilars enter the market.
- Sales volume projected to rise to approximately 500,000 yearly doses, capturing 60-70% of new PrEP prescriptions.
- Revenue estimates: USD 1.9–2.2 billion annually at current pricing.
Long-term (2028 and beyond)
- Price stabilization or reduction, potentially to USD 3,000–3,500 per dose, as market matures.
- Increased competition from alternative long-acting PrEP or once-yearly injectable formulations.
- Potential for biosimilar entry after patent expiry (expected around 2035), which could significantly impact pricing.
Factors Affecting Price Trajectory
- Regulatory changes and patent expirations.
- Technological developments leading to alternative formulations.
- Payer negotiation strength and formulary decisions.
- Market adoption rates in underserved regions, including Europe and Asia.
Key Challenges and Opportunities
- Challenges: High per-dose cost limits affordability, hurdles in insurance reimbursement, and patient acceptance.
- Opportunities: Expansion in adolescent and high-risk outpatient populations, increasing global access, and integration into broader HIV prevention strategies.
Conclusion
NDC 24385-0006, marketed as Apretude, holds a leading position in the long-acting HIV PrEP segment. Its price stability over the short term faces pressure from potential market expansion, payer negotiations, and future competition.
Key Takeaways
- The current list price is around USD 3,800 per dose, with total annual treatment costs exceeding USD 4,000.
- Market volume is expected to grow at 10-15% annually over the next two years.
- Price reductions are likely within the medium to long term due to increased competition and market maturation.
- Market penetration remains limited by high drug costs, despite increasing awareness and insurance coverage.
- Future biosimilar or generic approvals could significantly lower prices around 2035.
FAQs
1. What factors influence the pricing of cabotegravir (NDC 24385-0006)?
Drug pricing is influenced by manufacturing costs, market competition, payer negotiations, regulatory factors, and global demand. Pricing reflects both production expenses and market dynamics specific to HIV prevention.
2. How does the cost of Apretude compare to oral PrEP options?
Apretude's annual cost exceeds USD 4,000, whereas oral PrEP like Truvada averages USD 1,800–2,000 annually before insurance adjustments. The injectable offers adherence benefits but at a higher price.
3. What is the likelihood of price reductions in the next five years?
Price reductions are probable due to increased market competition, potential biosimilar entry (post-2035), and expanded insurance coverage. Payer negotiations may also lower net prices.
4. What markets beyond the U.S. are adopting Apretude?
European countries and Australia are evaluating long-acting injectables for HIV prevention, but approvals and adoption vary. Pricing strategies will differ based on regional economic factors and healthcare policies.
5. How could market developments impact the price projections?
Innovations in long-acting or long-interval formulations, biosimilar development, and changes in HIV epidemiology could influence market prices globally. Patent expirations and regulatory decisions are critical for future pricing.
References
[1] U.S. Food and Drug Administration. (2021). FDA approves first injectable drug to reduce the risk of HIV infection. https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-drug-reduce-risk-hiv-infection
[2] CDC. (2022). PrEP for people at risk for HIV. https://www.cdc.gov/hiv/basics/prep.html
[3] IQVIA. (2022). Global HIV market report.
[4] ViiV Healthcare. (2021). Prescribing information for Apretude. https://www.viivhealthcare.com/products/apr0tude/
[5] MarketWatch. (2022). HIV PrEP market size and forecasts. https://www.marketwatch.com/
