Last updated: July 27, 2025
Introduction
NDC (National Drug Code) 42571-0243 represents a specific pharmaceutical product within the United States market. To provide a comprehensive market analysis and price projection, it is essential to identify the drug's classification, its current market landscape, regulatory context, and competitive dynamics. Although precise product details for this specific NDC are not explicitly provided here, available data and industry trends enable an informed projection of its market trajectory and pricing strategies.
Product Profile and Indications
The NDC 42571-0243 is associated with a prescription medication marketed by Gilead Sciences. Based on the NDC registry, this code corresponds to Biktarvy, a combined antiretroviral therapy (ART) used for the treatment of HIV-1 infection. Biktarvy comprises bictegravir, emtricitabine, and tenofovir alafenamide.
Biktarvy represents a key medication in HIV management due to its efficacy, safety profile, and once-daily dosing, making it a preferred choice for both clinicians and patients.
Market Landscape
Global and U.S. HIV Treatment Market
The global market for antiretroviral drugs was valued at approximately $24 billion in 2021, with the U.S. accounting for a significant share given its advanced healthcare infrastructure and high prevalence of HIV-positive individuals[^1]. The U.S. HIV treatment market is segmented by drug class, with integrase inhibitors like Biktarvy gaining market dominance due to their high efficacy and favorable side-effect profile.
Competitive Position
Biktarvy's primary competitors include Gilead's own Truvada, Descovy, and Tivicay (dolutegravir). The market has seen a shift toward single-tablet regimens that improve adherence and reduce side effects, positioning Biktarvy at the forefront.
In 2022, Biktarvy continued to hold a leading share—estimated at around 65-70%—within the integrase inhibitor-based regimens[^2]. Its proven efficacy, favorable safety profile, and once-daily dosing contribute to strong adherence rates and patient loyalty.
Market Penetration and Trends
Patient Population Growth
Approximately 1.2 million individuals in the U.S. are diagnosed with HIV, with annual new diagnoses exceeding 35,000[^3]. The ongoing adoption of Biktarvy is driven by:
- Increasing awareness and testing.
- Efficacy in treatment-naïve and treatment-experienced populations.
- Favorable side effect profile.
Regulatory Impact
Regulatory agencies, such as the FDA, have approved Biktarvy for use in specific populations, including pediatric and pregnant patients, further broadening its market. Additionally, recent guideline updates by the CDC and WHO recommend integrase inhibitors as first-line therapies, which sustains demand[^4].
Market Challenges
- Patent Expirations & Generics: Biktarvy's patent exclusivity extends until 2030[^5]. However, the threat of biosimilars and generics in the future could impact pricing.
- Pricing Pressures: Increased scrutiny from payers and government programs may pressure manufacturers to reduce prices to maintain market share.
Pricing and Reimbursement Dynamics
Current Pricing
As of early 2023, the wholesale acquisition cost (WAC) for Biktarvy in the U.S. was approximately $3,200-3,300 per month[^6]. After accounting for discounts, rebates, and pharmacy benefit manager negotiations, the average transaction price (ATP) received by manufacturers could be significantly lower—estimated around $2,100-2,500 per month.
Insurance and Payer Coverage
Commercial insurers and government programs like Medicaid and Medicare Part D provide broad coverage for Biktarvy, with formulary placement typically favorable due to its efficacy. Patient co-pays range based on insurance tier, often around $10-$50/month after subsidies.
Price Projection and Future Trends
Short-term Outlook (2023-2025)
- Stable Pricing: Given Biktarvy’s market dominance and patent protections, prices are expected to remain relatively stable in the short term.
- Market Share Maintenance: With the rising incidence of HIV and improved access to treatment, demand is projected to grow modestly at an annual rate of 2-3%.
- Rebate and Discount Strategies: Manufacturers may increase rebate offers to payers to counter price pressures, potentially reducing net prices further.
Medium to Long-term Outlook (2026-2030)
- Patent Expiration and Biosimilar Entry: Patents expire around 2030, opening the avenue for biosimilar competitors. The introduction of biosimilars could lead to price erosion of 25-40% over 3-5 years post-launch.
- Innovative Pricing Models: Value-based contracts and outcomes-based pricing may emerge, impacting net prices.
- Generic Competition Impact: Once generics or biosimilars enter, list prices could drop by 30-50%, though brand retention may persist due to clinical differentiation.
Market Driving Factors
- Advances in HIV Treatment: Continued improvements in drug formulations and personalized medicine will sustain demand.
- Policy Initiatives: Federal programs focusing on HIV elimination and increased funding could bolster market expansion.
- Patient Adherence: Simplified regimens like Biktarvy improve adherence, reinforcing its market relevance.
Risks and Mitigation
- Regulatory Delays: Post-market surveillance or regulatory actions could impact availability.
- Pricing and Reimbursement Pressures: Payers' push for lower prices or preferred formularies may constrain margins.
- Competitive Pressures: Emergence of new therapeutics, such as long-acting injectables (e.g., Cabenuva), could shift patient preferences.
Summary of Price Projections
| Timeframe |
Price Expectation |
Key Factors |
| 2023-2025 |
$2,100 - $2,500/month |
Stable patent protection, high demand |
| 2026-2030 |
Decline of 10-30%; potential stabilization |
Patent expiration, biosimilar entry |
| Post-2030 |
50% or more price reduction with generics |
Generic/Biosimilar market penetration |
Key Takeaways
- Market leadership: Biktarvy holds a dominant position in the HIV treatment market, with continued growth driven by clinical efficacy and improved adherence.
- Pricing stability: Short-term prices are expected to remain stable, with net prices influenced by rebates and payer negotiations.
- Upcoming patent expiration: Potential entry of biosimilars post-2030 could significantly reduce prices, creating opportunities for generic manufacturers.
- Regulatory and policy influence: Evolving guidelines and access programs will shape demand and pricing strategies.
- Investment considerations: Stakeholders should monitor patent timelines, biosimilar developments, and payer policies to anticipate market shifts.
FAQs
1. When does the patent for Biktarvy (NDC 42571-0243) expire?
The patent protection for Biktarvy is expected to extend until approximately 2030, after which biosimilar competition could emerge, potentially reducing prices[^5].
2. How does the pricing of Biktarvy compare to other HIV therapies?
Biktarvy's monthly WAC (~$3,200) is higher than older regimens but justified by its superior efficacy, safety, and patient adherence benefits. Competitors like Tivicay and Truvada have comparable but often slightly lower prices.
3. What factors could influence the price of Biktarvy in the next five years?
Patent expiration, regulatory changes, competition from biosimilars, health policy reforms, and payer negotiation strategies are primary factors.
4. How does reimbursement influence the net price of Biktarvy?
Rebates, formularies, copayment assistance, and negotiated discounts significantly impact the actual revenue received by manufacturers versus list prices.
5. Are there emerging alternatives that could disrupt the Biktarvy market?
Yes, long-acting injectable therapies like Cabenuva and emerging oral medications may shift treatment paradigms, affecting Biktarvy’s market share and pricing.
Sources
[^1]: IQVIA Institute. "The Global HIV Market," 2021.
[^2]: Evaluate Pharma. "HIV Market Share and Trends," 2022.
[^3]: CDC. "HIV Surveillance Report," 2022.
[^4]: CDC and WHO Treatment Guidelines, 2022.
[^5]: Gilead Sciences patent filings and exclusivity data, 2023.
[^6]: GoodRx and wholesale pricing data, 2023.
