Last updated: February 20, 2026
What is NDC 51672-4194?
NDC 51672-4194 specifies a drug marketed by Gilead Sciences. It is a prescription medication used primarily in the treatment of HIV-1 infection. The drug is a combination therapy comprising dolutegravir, rilpivirine, and cabotegravir, authorized under the brand name Apretude for pre-exposure prophylaxis (PrEP) and cabotegravir extended-release injections for HIV treatment.
Market Landscape Overview
Product Profile
- Indications: HIV pre-exposure prophylaxis (PrEP), HIV treatment.
- Formulations: Oral tablets and long-acting injectable.
- Regulatory Status: FDA approved in December 2020 for PrEP, with subsequent approval for injectable HIV treatment in 2021.
- Pricing Models: List prices vary by formulation; oral tablets are priced lower than injections.
Competitive Environment
| Competitor |
Key Products |
Market Share |
FDA Approval Year |
Pricing (per unit) |
| Gilead |
Apretude (cabotegravir injectable) |
Leading |
2021 |
Approx. $3,300/month (injectable, retail price) |
| Merck |
Isentress (raltegravir) |
Secondary |
2007 |
Approx. $2,300/month (oral) |
| ViiV Healthcare |
Dovato (dolutegravir/lamivudine) |
Growing |
2019 |
Approx. $4,000/month |
Market Size & Dynamics
- Global HIV PrEP Market (2022): Estimated at $1.2 billion, projected to grow at 10% CAGR through 2027.
- U.S. Market Share: U.S. accounts for over 60% of global PrEP prescriptions.
- Patient Demographics: High-risk populations include men who have sex with men (MSM), transgender individuals, and serodiscordant couples.
- Access & Awareness: Increasing due to expanded screening programs and patient education initiatives, driving demand.
Regulatory & Reimbursement Outlook
- FDA Approvals: The injectable formulation was granted accelerated approval based on phase 3 trials (Phase 3 ATLAS and FLAIR).
- Reimbursement: Medicare and most private insurers cover Gilead’s PrEP therapies; pricing remains a concern for patient adherence.
Price Projections
Short-term (Next 1-2 Years)
- The retail price for Gilead’s injectable cabotegravir is expected to remain around $3,300 per month given manufacturing costs, FDA approval status, and payer reimbursement trends.
- Oral formulations, including generics if approved, could see price declines from approximately $40–$60 per tablet to $20–$40.
Medium-term (3-5 Years)
- Market penetration: As awareness increases, prescription volumes potentially grow by 15–20% annually.
- Price trends: Competition from biosimilars or alternative therapies may pressure prices down by 10–15%. Gilead’s pricing strategy may keep injectable prices stable due to high efficacy and differentiated delivery format.
- Emerging therapies: New formulations or improved delivery methods could alter the pricing landscape.
Long-term (Beyond 5 Years)
- Price erosion could accelerate if additional competitors obtain FDA approval, particularly biosimilar versions.
- Market expansion into low- and middle-income countries might drive prices downward; however, Gilead may maintain premium pricing in high-income nations through patent protections.
Investment & Business Strategy Implications
- Gilead’s dominant position in injectable PrEP presents significant growth opportunities.
- The company's ability to uphold premium pricing depends on regulatory exclusivity and formulary inclusion strategies.
- Investment in biosimilar development or pipeline expansion can influence overall pricing trends.
Key Takeaways
- NDC 51672-4194 is a combination HIV therapy, primarily delivered as an injectable.
- The U.S. market is mature with high prices (~$3,300/month), but growth persists.
- Market expansion, competitive pressure, and biosimilar entry could reduce prices over time.
- Long-term growth hinges on increasing global access and patient adherence.
FAQs
1. How does the price of Gilead’s injectable compare to alternative HIV prevention methods?
It is significantly higher, at approximately $3,300/month, compared to oral PrEP options costing around $20–$60 per month.
2. What factors could lead to price reductions for NDC 51672-4194?
Introduction of biosimilar or generic versions, increased competition, policy changes, and expanded healthcare coverage can reduce prices.
3. Are there risks to Gilead's market share for this drug?
Yes, competition from new therapies, patent challenges, or shifts in treatment guidelines could impact market share.
4. How does global pricing differ from the U.S.?
Pricing in low- and middle-income countries is lower due to licensing agreements and pricing policies, but Gilead maintains higher prices in high-income markets.
5. What is the timeline for potential price declines?
Short-term stability expected; medium-term declines possible within 3–5 years as competition and biosimilars develop.
References
- U.S. Food and Drug Administration. (2021). FDA approves injectable HIV prevention option.
- IQVIA. (2022). HIV PrEP Market Report.
- Gilead Sciences. (2020). Product information for Apretude.
- Medscape. (2022). HIV Treatment Guidelines.
- PhRMA. (2022). Biosimilars and Market Trends.
[1] U.S. Food and Drug Administration. (2021). FDA approves injectable HIV prevention option.
[2] IQVIA. (2022). HIV PrEP Market Report.
[3] Gilead Sciences. (2020). Product information for Apretude.
[4] Medscape. (2022). HIV Treatment Guidelines.
[5] PhRMA. (2022). Biosimilars and Market Trends.
