Last updated: February 28, 2026
What Is NDC 47918-0891?
NDC 47918-0891 identifies Rukobia (Fostemsavir), an HIV-1 attachment inhibitor approved by the FDA in July 2019. It is prescribed for heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
Market Landscape
Patient Population
- Estimated global HIV/AIDS population: 38 million (UNAIDS, 2022)
- HIV-positive adults with multi-drug resistant infections: approximately 5-10%
- U.S. market estimate: 1.2 million people living with HIV, with about 10–15% classified as heavily treatment-experienced
Competitive Landscape
Main Treatments
- Existing drugs focus on integrase inhibitors, protease inhibitors, and entry inhibitors.
- Rukobia appeals primarily to patients with resistance to multiple drug classes.
Market Dynamics
- Rukobia has a niche market due to its indication for heavily treatment-experienced patients.
- The drug's use is limited by its oral administration route and side effect profile.
- Entry barriers include high treatment resistance and limited alternative options.
Prescription Trends
- Initial uptake in 2020 remained slow with approximately 2,000 prescriptions nationally.
- By 2022, prescriptions increased to roughly 4,500 annually.
- Growth projected based on expanding resistance and specific indication.
Pricing and Reimbursement Status
Current Price
- Wholesale Acquisition Cost (WAC): approximately $2,000 per 30-count pill (per month supply).
- Price varies by payer segmentation, with negotiated discounts and insurance coverage influencing final patient out-of-pocket expenses.
Cost Considerations
- Rukobia's price positions it as a high-cost therapy within the HIV market.
- Insurance coverage is typical, but access hurdles exist for uninsured or underinsured patients.
Market Penetration
- Limited penetration linked to treatment resistance criteria and prescribing habits.
- Use predominantly among specialized infectious disease clinics.
Price Projections and Market Outlook
| Year |
Estimated Prescriptions |
Price per Month |
Estimated Revenue |
Comments |
| 2023 |
5,500 |
$2,000 |
~$132 million |
Steady growth expected |
| 2024 |
8,000 |
$2,000 |
~$192 million |
Expanded use in resistant cases |
| 2025 |
12,000 |
$2,100 |
~$302 million |
Slight price increase; more adoption |
| 2026 |
15,000 |
$2,100 |
~$378 million |
Continued market expansion |
Assumptions
- Prescriptions increase at a compound annual growth rate (CAGR) of approximately 21% through 2026.
- Price adjustments reflect inflation, formulary negotiations, and new data.
- The drug maintains a steady share within its niche segment.
Risks Affecting Market and Price
- Shifts toward newer or more effective resistance profiles.
- Emergence of generic or biosimilar options, though unlikely given the drug's patent exclusivity.
- Changes in treatment guidelines affecting resistant populations.
Patent and Exclusivity Status
- Patent protection extends to approximately 2030.
- Market exclusivity in the U.S. grants monopolistic pricing for the foreseeable future.
Key Takeaways
- NDC 47918-0891 (Rukobia) occupies a niche market for heavily treatment-experienced HIV patients.
- Current price point is around $2,000 monthly; revenues are growing steadily based on increasing prescriptions.
- Market growth depends on resistance patterns, clinician adoption, and approval of combination therapies.
- The drug’s patent protection and limited competition support stable pricing; significant price erosion is unlikely within the next five years.
FAQs
1. What is the primary indication for NDC 47918-0891?
Treatment of heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
2. How does its price compare to other HIV therapies?
It is among the higher-priced therapies, with a typical monthly cost around $2,000, reflecting its niche status and resistance profile.
3. What factors influence future price trends?
Prescribing volume, resistance trends, insurance negotiations, and potential new treatment options.
4. Is market expansion likely in the near term?
Yes, as resistance profiles evolve, more patients may become eligible, but growth remains constrained by treatment guidelines.
5. When is patent expiration expected?
Approximately 2030, after which generic competition could influence pricing.
References
- UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet.
- FDA. (2019). FDA approval letter for Rukobia (Fostemsavir).
- IQVIA. (2022). Prescription data for HIV medications.
- Mirae Asset Global Research. (2022). HIV drug market analysis.
- United States Patent and Trademark Office. (2022). Patent status for Fostemsavir.
