Last updated: February 25, 2026
What is NDC 51407-0373?
The National Drug Code (NDC) 51407-0373 corresponds to Apretude (cabotegravir extended-release injectable suspension). Approved by the FDA in December 2021, Apretude is used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in at-risk adults and adolescents weighing at least 35 kg.
Market Landscape
Current Market Size
- The global HIV prevention market was valued at approximately USD 3.2 billion in 2022, projected to reach USD 5 billion by 2028.
- In the U.S., the PrEP segment experienced a compound annual growth rate (CAGR) of around 15% from 2018 to 2022, driven by increased testing and awareness campaigns.
Competition
- Truvada (tenofovir/emtricitabine): Dominates current PrEP therapy, with approximately 95% of the market share prior to Apretude's approval.
- Descovy (tenofovir alafenamide/emtricitabine): Gaining traction due to better renal and bone safety profiles.
- Other entrants: Generic formulations are available; however, none is directly replacing injectable options yet.
Adoption Drivers
- FDA approval of Apretude completes a two-dose regimen annually, improving adherence compared to daily pills.
- CDC recommendations favor long-acting injectable PrEP for certain populations.
- HIV incidence rates have remained steady nationally, with targeted vaccination and prevention programs increasing demand.
Barriers to Market Penetration
- Cost of treatment remains high, partially driven by manufacturing expenses.
- Limited awareness among providers and at-risk populations.
- Reimbursement challenges and insurance coverage limitations for newer therapies.
Price Projections
Current Pricing
- The list price of Apretude was set at approximately USD 3,500 per dose when launched in early 2022.
- Insurance coverage and assistance programs reduce out-of-pocket costs for many patients.
- Compared to Truvada, which retails at about USD 1,800 per month, Apretude's cost translates to roughly USD 7,000 annually if two doses are administered per year.
Short-term Price Trends (2023–2025)
- Slight downward pressure expected due to increased competition if biosimilars or generics enter the market.
- Negotiation with payers and Medicaid can reduce effective patient costs by 20–30%.
Long-term Outlook (2025–2030)
| Year |
Predicted List Price per Dose |
Estimated Average Price to Payers |
Rationale |
| 2025 |
USD 3,200 |
USD 2,200 |
Market stabilization, competition with biosimilars. |
| 2030 |
USD 2,800 |
USD 1,800 |
Increased competition, generic entry, improved reimbursement. |
Key Variables Affecting Price
- Entry of biosimilar or generic versions could reduce list prices by 40–50%.
- Expanded Medicare and Medicaid coverage may lower net prices.
- Policy shifts toward value-based pricing models could influence actual transaction costs.
Regulatory and Market Access Considerations
- Continued licensing in other countries may expand global market size.
- WHO inclusion in essential medicines list can enhance access in low-income countries.
- Ongoing pharmacovigilance and real-world evidence collection may influence pricing negotiations and reimbursement policies.
Key Market Dynamics Summary
- The U.S. market for injectable PrEP remains nascent but is expected to grow significantly.
- Apretude has secured a niche due to its long-acting profile but faces competition from established oral therapies.
- Pricing is expected to decline gradually over five years, driven by biosimilar entry and payer negotiations.
Key Takeaways
- Apretude's launch price is high; market growth hinges on awareness and reimbursement expansion.
- Competition from oral generics and biosimilars will likely force price reductions.
- Long-acting injectable PrEP is positioned as a preferred alternative for adherence-challenged populations.
- Market size and penetration will expand as international approvals and guidelines evolve.
- Cost reductions will be pivotal for broader adoption, especially in low-income settings.
FAQs
Q1: Will Apretude's price decline significantly within the next five years?
A1: Yes, biosimilar entries and increased competition are expected to reduce prices by 40–50%.
Q2: How does Apretude compare cost-wise to current oral PrEP therapies?
A2: It costs roughly twice as much annually, but offers adherence advantages that might justify premiums.
Q3: What factors influence Apretude's market uptake?
A3: Reimbursement policies, brand awareness, provider familiarity, and ongoing guideline endorsements.
Q4: Are there international markets for NDC 51407-0373?
A4: Not yet; future approvals in other countries could expand its reach.
Q5: How might pricing models evolve for drugs like Apretude?
A5: Shift toward value-based pricing linked to real-world outcomes is anticipated.
References
[1] IQVIA. (2022). "HIV Prevention Market Report."
[2] CDC. (2021). "Recommendations for HIV Prevention."
[3] FDA. (2021). "Apretude (cabotegravir) Approval Announcement."
[4] GlobalData Healthcare. (2022). "HIV Prevention Drug Market Forecasts."
[5] ASM. (2022). "Long-Acting Injectable PrEP: Market Impact."
