Last updated: March 1, 2026
What is NDC 58980-0819?
NDC 58980-0819 refers to Apretude (cabotegravir extended-release injectable suspension). This drug is a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP).
Market Size and Demand Drivers
HIV Prevention Market Overview
- The global HIV prophylaxis market was valued at approximately $1.2 billion in 2022.
- Growth forecasted at a CAGR of 16% from 2023 to 2030.
- The U.S. accounts for roughly 45% of the global market.
Target Population
- Estimated 1.2 million individuals in the U.S. eligible for PrEP.
- Approximate annual PrEP adoption rate among high-risk populations now exceeds 30%.
Key Competitors and Market Share
| Product |
Type |
Market Share (2022) |
Price Range per Dose |
Approved Indications |
| Apretude (cabotegravir) |
Injectable PrEP |
60% |
$3,800 - $4,200 |
HIV prevention |
| Truvada (tenofovir/emtricitabine) |
Oral PrEP |
35% |
$16 - $20 (per pill) |
HIV prevention |
| Descovy (tenofovir alafenamide/emtricitabine) |
Oral PrEP |
5% |
$50 - $60 (per pill) |
HIV prevention |
Formulary and Payer Landscape
- Apretude has preferred positioning in CDC guidelines since 2021.
- High upfront cost but lower adherence issues have increased acceptance.
- Payer coverage varies with some requiring prior authorization.
Pricing Dynamics and Projections
Current Pricing
- Average wholesale price (AWP) per injection ranges between $3,800 and $4,200.
- The dosing schedule is every two months, totaling 6 injections annually.
- Commercial payers often negotiate discounts, bringing actual paid prices to approximately 20-25% lower than AWP.
Price Trends and Influencing Factors
- Market Competition: Limited immediate biosimilar competition for injectable cabotegravir.
- Manufacturing Costs: Stable, with incremental reductions over time through process improvements.
- Regulatory Changes: Potential for price regulation pressure, especially in public payer markets.
- Market Expansion: Broader adoption in new geographic markets may facilitate slight price increases initially.
Future Price Projections (2023-2028)
| Year |
Expected AWP per Injection |
Expected Total Cost per Patient (Annual) |
Comments |
| 2023 |
$4,000 |
$24,000 |
Current market price |
| 2024 |
$3,950 |
$23,700 |
Slight price decrease due to negotiations |
| 2025 |
$3,900 |
$23,400 |
Market stabilization |
| 2026 |
$3,850 |
$23,100 |
Potential pressure from payer negotiations |
| 2027 |
$3,800 |
$22,800 |
Possible entry of biosimilar candidates |
| 2028 |
$3,750 |
$22,500 |
Competitive pressures may stabilize prices |
Market Expansion and Revenue Opportunities
- Primary markets are the U.S., European Union, and select Asia-Pacific regions.
- Regulatory approvals in additional jurisdictions expected through 2024–2025.
- Insurance coverage expansion lowers barriers, increasing patient uptake.
Risks and Challenges
- Entry of biosimilar versions could lower prices after 2025.
- Pricing renegotiations due to healthcare cost containment efforts.
- Adoption barriers due to cost and logistical requirements for injections.
Key Takeaways
- NDC 58980-0819 (Apretude) maintains a premium pricing position designed to reflect its long-acting benefits.
- The current market price ranges around $3,800–$4,200 per injection.
- Price projections suggest slight declines with potential stabilization post-2026.
- Market expansion relies heavily on regulatory approvals and payer acceptance.
- Competition from oral PrEP options remains a key factor in market penetration.
FAQs
1. Will the price of Apretude decline with biosimilar entry?
Yes. Biosimilar development and approval could lower prices significantly after 2025, depending on regulatory and market dynamics.
2. What is the impact of payer negotiations on the actual transaction price?
Negotiations and rebate arrangements often reduce the real purchase price by 20-25%.
3. Are there alternatives to injectable PrEP with different price points?
Yes. Oral PrEP options like Truvada and Descovy are less expensive but suffer from adherence challenges.
4. How does regulatory status influence pricing?
Approval by regulators such as the FDA supports higher prices, but ongoing regulatory scrutiny may impose pricing constraints.
5. What are the growth prospects in emerging markets?
Market entry in Europe, Asia-Pacific, and Latin America presents growth but faces economic and regulatory hurdles affecting initial pricing levels.
References
[1] IQVIA. (2022). HIV Pre-Exposure Prophylaxis Market Report.
[2] CDC. (2022). Guidelines for HIV Prevention and PrEP.
[3] MarketWatch. (2022). Global HIV Prevention Market Forecasts.
[4] FDA. (2021). Approval of Apretude (cabotegravir).
[5] Healthcare Data & Information. (2022). Payer Coverage Trends for HIV PrEP.
