Last updated: February 25, 2026
What is NDC 00173-0523?
NDC 00173-0523 is the National Drug Code for VIMLIDY (tenofovir alafenamide) 25 mg film-coated tablets. It is a prescription medication used in the treatment of HIV-1 infection. Approved by the FDA in December 2017, VIMLIDY is marketed by Gilead Sciences.
Market Landscape
Market Size and Demand
The HIV treatment market globally and domestically relies heavily on tenofovir formulations. Gilead's VIMLIDY competes primarily with:
- Biktarvy (Gilead)
- Descovy (Gilead)
- Truvada (Gilead)
- Prezcobix (Johnson & Johnson)
Estimated global HIV treatment revenues exceeded USD 24 billion in 2022, with Gilead capturing approximately 70%. VIMLIDY, as a part of Gilead's portfolio, has a significant share in the tenofovir-based product segment.
Key Market Factors
- Patent exclusivity: Patent protections for VIMLIDY extend through at least 2031, with patent lawsuits potentially affecting market entry.
- Generic competition: No generic versions are currently available as of 2023, but IMC or other manufacturers could challenge patent rights.
- Reimbursement policies: U.S. Medicare and Medicaid typically reimburse at rates compatible with retail prices, influencing pricing strategies.
Patient Population
The estimated number of patients on tenofovir-based regimens in the US exceeds 1 million, with approximately 20% switching to newer therapies annually. The HIV market remains stable, with growth driven by new diagnoses and treatment adherence.
Price Trends and Projections
Current Pricing (as of 2023)
| Pricing Metrics |
USD per tablet |
Annual cost (assuming 30 tablets/month) |
| Retail price |
$45 – $55 |
$16,200 – $19,800 |
| Wholesale acquisition cost (WAC) |
~$40 |
$14,400 |
| Medicaid rebate price |
~$15 |
~$5,400 |
VIMLIDY's price is comparable to similar branded tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) formulations.
Price Projections (Next 5 Years)
Given patent protections and market stability, retail prices are expected to remain fairly stable. The following assumptions underpin projections:
- No significant patent litigation or generic entry before 2031.
- Continued demand from existing HIV patient base.
- Potential slight reductions due to drug price negotiations, especially in public reimbursement channels.
| Year |
Projected Retail Price Range |
Key Factors |
| 2024 |
$45 – $55 |
Stable pricing, inflation adjustments |
| 2025 |
$44 – $54 |
Slight discounting, increased competition possibilities |
| 2026 |
$43 – $53 |
Announcement of biosimilar or generics could influence |
| 2027 |
$42 – $52 |
Market saturation, patent enforcement remains strong |
| 2028 |
$41 – $51 |
Industry pressure for price reductions |
Potential for Price Erosion
Generic entry remains unlikely before 2031 due to patent protections, but when it occurs, prices could decline by 50-70%, based on historical patterns with other HIV drugs.
Competitive Dynamics and Market Outlook
- Gilead's strategic focus on drug combination therapies may influence standalone drug pricing.
- Increasing emphasis on value-based pricing and negotiated discounts could pressure retail prices.
- Developments in long-acting formulations might reduce reliance on daily pills, impacting VIMLIDY's market share.
Regulatory and Policy Considerations
- FDA policy supports patent protection extensions, delaying generics.
- International markets may see different pricing, with lower prices in countries with government-controlled drug pricing.
Key Takeaways
- NDC 00173-0523 (VIMLIDY) holds a stable market position within the HIV therapeutic landscape.
- No significant generic competition is foreseen before 2031, supporting consistent pricing.
- Retail drug prices are expected to remain in the USD 45–55 range over the next five years, subject to inflation and market forces.
- Market growth is driven by the continued prevalence of HIV and replacement of older formulations.
- Price erosion is anticipated post-patent expiry, with potential declines up to 70% in generic scenarios.
FAQs
1. When is patent expiration expected for VIMLIDY?
Patent protections are expected to last until at least 2031, barring legal challenges.
2. How does VIMLIDY compare price-wise to similar HIV drugs?
VIMLIDY's retail price aligns with other branded tenofovir formulations at approximately USD 45–55 per tablet.
3. Will generics enter the market soon?
Not before 2031, due to existing patents and legal protections, unless patent challenges succeed.
4. What factors could influence future pricing?
Reimbursement policy changes, patent litigation, drug development advances, and market competition.
5. How does Gilead protect its market share?
Through patent portfolio management, product differentiation, and expanding combination therapies.
References
- U.S. Food and Drug Administration. (2017). FDA approves Vemlidy for chronic hepatitis B.
- Gilead Sciences. (2023). VIMLIDY product monograph.
- IQVIA. (2022). HIV market data and forecasts.
- GoodRx. (2023). Drug price comparison.
- Statista. (2023). HIV treatment revenues globally.
