Last updated: February 15, 2026
Overview and Product Context
NDC 13107-0004 corresponds to Apretude (cabotegravir extended-release injections) marketed by ViiV Healthcare. Approved by the FDA in December 2021, Apretude is used for HIV pre-exposure prophylaxis (PrEP). It offers an alternative to daily oral PrEP, with injections administered every two months after initial dosing.
Market Size and Growth Potential
The PrEP market has expanded following FDA approval of injectable options. In 2022, an estimated 1.3 million Americans were eligible for PrEP, with nearly 120,000 receiving treatment. The HIV prevention market is projected to grow at a CAGR of 6.7% through 2027, driven by increased awareness, expanded indications, and uptake among high-risk populations. Injectable PrEP’s share in the overall PrEP market reached approximately 15% in 2022, with projections to grow faster given patient preference for less frequent dosing.
Competitive Landscape
Key competitors include:
- Descovy (emtricitabine and tenofovir alafenamide): oral daily medication, marketed by Gilead Sciences.
- Truvada (emtricitabine and tenofovir disoproxil fumarate): older oral PrEP, Gilead.
- Cabotegravir injections (Apretude): marketed by ViiV Healthcare.
Emerging options include long-acting injectable cabotegravir for HIV treatment, with regulatory filings in several regions. Oral alternatives dominate initial uptake, but injectable formulations like Apretude target adherence issues with daily pills.
Pricing Strategy and Current Price Point
The wholesale acquisition cost (WAC) for Apretude was approximately $3,500 per injection (2022). ViiV Healthcare's pricing reflects the two-month dosing schedule, effectively positioning Apretude at an annual cost of around $21,000 per patient. Pricing considerations include:
- Reimbursement standards.
- Competitive pricing of oral PrEP (average annual cost $2,000-$3,000).
- The value proposition of improved adherence and clinical outcomes.
Coverage and reimbursement vary by insurer, with Medicaid and commercial plans increasingly including injectable PrEP.
Price Projections (Next 3-5 Years)
Forecast assumptions:
- Annual sales volume starting at 15,000–20,000 prescriptions in 2023, with growth to 50,000–70,000 prescriptions by 2026.
- Market penetration increases over time due to expanding evidence and clinician acceptance.
- Price adjustments driven by market competition, payer negotiations, and production costs.
- Discounting factors such as increased competition from other long-acting agents and generics.
Projected Pricing Trends
| Year |
Estimated Price per Injection |
Projected Annual Revenue |
Rationale |
| 2023 |
$3,500 |
$52.5 million (assuming 15,000 prescriptions) |
Initial market entry; premium positioning. |
| 2024 |
$3,400 |
$85 million (assuming 25,000 prescriptions) |
Slight price compression; broader adoption. |
| 2025 |
$3,200 |
$136 million (assuming 40,000 prescriptions) |
Increasing competition; volume growth. |
| 2026 |
$3,000 |
$210 million (assuming 70,000 prescriptions) |
Mature market; sustained demand; potential price stabilization. |
Risks & Influencing Factors
- Market acceptance: Uptake depends on clinician and patient acceptance.
- Reimbursement policies: Insurers may negotiate prices downward.
- Competitive innovations: Development of alternative formulations or combination therapies.
- Regulatory changes: Any modifications affecting pricing or indications.
Regulatory and Policy Environment
The Biden administration’s focus on HIV prevention may facilitate broader coverage for PrEP. CMS and private payers’ policies can influence pricing dynamics. The push towards value-based arrangements may incentivize price negotiations aligned with clinical outcomes.
Summary
Apretude’s pricing remains relatively high compared to oral PrEP, justified by its long-acting formulation and adherence benefits. Market growth is expected to accelerate, with prices likely to see moderated declines driven by increased competition and payor negotiations. Drug manufacturers should monitor formulary placements, reimbursement trends, and competitive launches to optimize pricing strategies.
Key Takeaways
- The current price for NDC 13107-0004 is ~$3,500 per injection, with annual costs around $21,000.
- The PrEP market is growing at a 6.7% CAGR, with injectable modalities gaining share.
- Expected sales could reach $200 million+ by 2026, contingent on market acceptance and payer coverage.
- Prices are likely to decline gradually over time amid rising competition and negotiations.
- Policymaker initiatives for HIV prevention could influence reimbursement and market expansion.
FAQs
Q1: What are the main factors influencing the price of Apretude?
Payer negotiations, market competition, production costs, and reimbursement policies significantly influence pricing. Clinical benefits and market acceptance also impact willingness to pay.
Q2: How does the cost of Apretude compare to oral PrEP?
Apretude’s annual cost (~$21,000) exceeds oral PrEP (~$2,000–$3,000), but its dosing schedule may improve adherence, potentially reducing breakthrough infections and long-term costs.
Q3: What is the outlook for generic versions of cabotegravir?
No generics are currently available for cabotegravir injections; patent protections and exclusivity will likely extend until at least 2030. However, biosimilar or alternative long-acting formulations could emerge, impacting pricing.
Q4: How significant is insurance coverage for market penetration?
Coverage impacts patient access and reimbursement revenues. Medicaid and private insurers increasingly include injectable PrEP, facilitating acceptance but also pressuring prices.
Q5: What developments could impact future pricing?
Introduction of competitive long-acting agents, policy shifts towards value-based care, and potential price regulations could influence pricing strategies and market size.
Citations
- CDC. HIV Surveillance Report 2022; available at https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html.
- ViiV Healthcare. Apretude FDA approval announcement, December 2021.
- IQVIA. PrEP market analysis, 2022.
- Gilead Sciences. Oral PrEP pricing and market data, 2022.
- PhRMA. Pharmaceutical innovation and pricing trends, 2022.
