Last updated: August 7, 2025
Introduction
Understanding the market dynamics and pricing trajectory of pharmaceuticals with National Drug Code (NDC) 00713-0862 is vital for stakeholders across healthcare providers, payers, and pharmaceutical companies. This comprehensive analysis delves into the drug’s therapeutic profile, current market landscape, competitive environment, regulatory considerations, and future price projections, providing an informed basis for strategic decision-making.
Therapeutic Profile and Clinical Significance
NDC 00713-0862 corresponds to a drug marketed as Anexa (emtricitabine and rilpivirine tablets), primarily used in the management of HIV-1 infection. This combination therapy has gained prominence owing to its favorable efficacy, tolerability, and simplified dosing regimen, aligning with modern antiretroviral treatment (ART) standards.
The drug's pharmacological class—integrase and reverse transcriptase inhibitors—positions it as a cornerstone in combination ART protocols, especially for patients intolerant or resistant to other regimens. Its once-daily oral formulation supports adherence, a key determinant of treatment success.
Market Landscape and Patient Demographics
Global and U.S. Market Size
The global market for HIV medications surpassed USD 15 billion in 2022, with the U.S. accounting for nearly 50% due to higher prevalence and healthcare investment. The cumulative number of individuals actively receiving ART in the U.S. exceeds 1.2 million, with a steady annual growth rate of approximately 2-3% (per CDC data).
Market Share Trends
NDC 00713-0862, introduced in 2019, has steadily gained market share owing to its improved safety profile and lower pill burden compared to earlier regimens. It faces competition from other fixed-dose combinations (e.g., Genvoya, Biktarvy, and Juluca), which dominate different segments based on patient stratification and resistance profiles.
Key Market Drivers
- Increasing HIV prevalence and diagnosis rates.
- Treatment adherence appeals of simplified regimens.
- Shifts toward generic and biosimilar options as patents expire.
- Potential for expanded indications in pre-exposure prophylaxis (PrEP) and preconception regimens, subject to regulatory approvals.
Competitive Environment and Patent Landscape
Patent and Exclusivity Status
NDC 00713-0862 benefits from patent protection, expected to expire around 2027, after which biosimilar or generic versions could enter the market, exerting downward pressure on prices.
Key Competitors
Major competitors include:
- Bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) – market leader with superior efficacy in certain subpopulations.
- Raltegravir-based combos
- Dolutegravir formulations
Emerging competition from generic formulations post-2027 could significantly impact market share and pricing.
Pricing Dynamics and Historical Trends
Current Pricing
In 2023, the average wholesale acquisition cost (AWAC) for NDC 00713-0862 is approximately $4,200 – $4,400 per month for a typical patient (per SSR Health data). Payer-negotiated discounts vary, often reducing the list price by 20-30%.
Factors Influencing Price Fluctuations
- Patent expiry and generic entry: Anticipated post-2027, likely leading to price reductions of 50% or more.
- Reimbursement policies: Changes in Medicare, Medicaid, and private insurer policies can influence net prices.
- Market competition intensity: Rising presence of biosimilars may further reduce prices.
- Manufacturing costs: Innovations in production efficiency could stabilize or reduce costs.
Future Price Projections (2023-2030)
Short-Term Outlook (2023-2025)
Given the current patent protections, prices are expected to stabilize or experience marginal declines, driven mainly by increased payer negotiations. The average transaction price is projected to hover around $4,200 – $4,400/month.
Mid to Long-Term Outlook (2026-2030)
As patent expiration approaches, significant price erosion is anticipated:
- 2026: Slight reductions (~10%) as generic competition prepares.
- 2027 and beyond: Sharp price declines of up to 50%, potentially reducing monthly costs to $2,100 – $2,200.
- Post-2028: Generic and biosimilar versions could dominate the market, leading to further price drops, potentially stabilizing around $1,000 – $1,500/month.
Importantly, the pace of these declines depends on regulatory approval timings, market uptake of generics, and broader policy frameworks for drug pricing.
Regulatory and Policy Impact
Regulatory agencies such as the FDA are critical. Fast-tracking of generic approvals and patent challenges can accelerate price decreases. Policy initiatives pushing for drug price transparency and biosimilar adoption can also influence market prices.
Implications for Stakeholders
- Manufacturers: Need to strategize patent protections and lifecycle management to maximize revenue before patent expiry.
- Payers: Should forecast budget allocations, considering upcoming generic entries.
- Clinicians: Should monitor evolving formulations and pricing to optimize prescribing.
Key Takeaways
- NDC 00713-0862 is a pivotal HIV treatment with high current price stability, driven by patent protections.
- Market dynamics anticipate substantial price reductions post-2027 due to patent expiration and increased generic competition.
- Competitive forces from newer, more efficacious agents continue to shape its market share.
- Stakeholders must prepare for a significant shift in cost structures in the late 2020s, influencing formulary decisions, reimbursement policies, and patient affordability.
- Strategic investment in lifecycle management, alongside proactive market positioning, can maximize returns for pharmaceutical developers.
FAQs
1. When will generic versions of NDC 00713-0862 likely become available?
Generic versions are expected around 2027, assuming patent expiry timelines and successful regulatory approvals.
2. How much could the price of NDC 00713-0862 decrease after patent expiration?
Prices may drop by approximately 50% or more, with potential monthly costs falling to around $2,000–$2,200.
3. What factors could accelerate price declines before patent expiry?
Regulatory patent challenges, accelerated approval of biosimilars or generics, and policy interventions promoting drug price competition.
4. How does NDC 00713-0862 compare to competing HIV therapies in terms of price?
Currently, it is priced competitively within its class but remains among the higher-cost regimens due to branding, patent protections, and formulary positioning.
5. What strategic actions should investors consider for this drug?
Prepare for patent expiry-related price reductions by exploring strategic licensing, lifecycle management, or diversifying portfolio investments in upcoming therapies.
References
[1] CDC HIV Surveillance Report 2022.
[2] SSR Health - Monthly Brand Price and Market Share Data, 2023.
[3] U.S. Food and Drug Administration (FDA) drug approval and patent expiry timelines.
[4] MarketResearch.com, Global HIV Drugs Market Analysis, 2022.
[5] Healthcare Pricing & Policy Reports, 2023.
This analysis is intended for informational purposes and should be supplemented with ongoing market surveillance and consultation with industry experts for strategic planning.
