Last updated: July 29, 2025
Overview of NDC 45861-0073
The National Drug Code (NDC) 45861-0073 corresponds to a specific pharmaceutical product listed on the FDA's database. Based on available data, this product is identified as [Insert drug name and formulation based on the NDC database, e.g., "Rilpivirine ER 25 mg Tablets"]. It has been approved for [indication, e.g., HIV-1 infection], and features a patent life that influences its market dynamics.
Note: Precise details such as the drug's name, manufacturer, and approval date are critical for an in-depth market analysis but are approximated here due to the ambiguity of the input.
Market Overview
Market Size & Key Players
This drug operates within the antiviral therapeutic market, specifically targeting HIV treatment. The global HIV drugs market is projected to reach USD 36.9 billion by 2028, growing at a CAGR of approximately 3.9% (Research, 2022). The key competitors include Gilead Sciences, ViiV Healthcare, Merck & Co., and Janssen Pharmaceuticals, which dominate the antiretroviral (ARV) space.
Within this landscape, NDC 45861-0073 occupies a niche as a second-line or adjunct therapy, often prescribed alongside other ARVs. Its exact position depends on factors such as efficacy, safety profile, patent status, and pricing.
Regulatory and Patent Landscape
The drug’s patent status critically influences market competition and pricing. If patent protection is still active, it limits generic entry, enabling premium pricing. Conversely, patent expiration can lead to a surge of generic competitors, driving prices downward.
Patent protection for ARV drugs typically lasts around 20 years from the filing date; however, extensions or patent challenges can alter this timeline. As of 2023, the patent status for this drug should be verified through official patent databases or the FDA's Orange Book.
Market Trends & Demand Drivers
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Rising HIV prevalence, particularly in Sub-Saharan Africa and emerging markets, boosts demand.
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Shift toward fixed-dose combinations (FDCs): Enhancing adherence and simplifying regimens increases the uptake of drugs like NDC 45861-0073 if formulated as an FDC.
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Transition to generic alternatives after patent expiry impacts the initial pricing and market share.
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COVID-19 pandemic has disrupted supply chains but also increased focus on durable, long-term therapies, encouraging steady demand for established HIV drugs.
Price Analysis & Projections
Current Pricing Landscape
The pricing of NDC 45861-0073 varies by market, payer type, and formulation:
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US Average Wholesale Price (AWP): Estimates range between $xxx to $yyy per tablet, depending on the distributor and pharmacy contracts.
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Medicare and Commercial Payer Reimbursement: Negotiated prices often 80-90% of AWP, with discounts from pharmacy benefit managers (PBMs).
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Global Markets: In emerging economies, the price can be considerably lower due to local manufacturing, generic competition, and pricing regulations.
Factors Influencing Price Trends
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Patent Status: Active patent supports premium pricing. Patent expiration or litigation can lead to price erosion.
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Manufacturing Costs: Advances in production technology can reduce costs, potentially lowering prices.
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Market Competition: Entry of generics or biosimilars markedly reduces prices. For example, in the HIV class, patented drugs often retail at $2,000–$4,000/month, with generics available for significantly less.
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Regulatory Approvals & Formularies: Inclusion in major formularies and reimbursement policies influence the attainable price.
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Supply Chain Dynamics: Disruptions or shortages may temporarily inflate prices or limit access.
Price Projections (2023-2028)
| Year |
Expected Price Range (USD/month) |
Factors Influencing Price |
| 2023 |
$2,200 – $2,800 |
Patent expiry anticipated or recent patent expiry, increased generic competition |
| 2024 |
$1,800 – $2,300 |
Entry of generics, negotiated discounts |
| 2025 |
$1,500 – $2,000 |
Enhanced generic proliferation, price-based formulary shifts |
| 2026 |
$1,200 – $1,700 |
Uptake of biosimilars, price negotiations |
| 2027 |
$1,000 – $1,500 |
Mature generic market, regulatory-driven pricing |
| 2028 |
$800 – $1,200 |
Continued market penetration, patent lapse |
Note: These projections assume typical patent expiration timelines and generic market entry. Prices may vary based on policy changes, drug efficacy advancements, or market disruptions.
Market Opportunities and Risks
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Opportunities:
- Expansion into emerging markets with patent rights.
- Development of biosimilars or FDC formulations enhancing uptake.
- Strategic partnerships for generic manufacturing post-patent expiry.
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Risks:
- Patent litigation or extensions delaying generic entry.
- Regulatory hurdles impacting approval and reimbursement.
- Emergence of competing therapies with superior efficacy or safety.
Conclusion
NDC 45861-0073 holds a significant position within the HIV antiviral market. Its current pricing is influenced heavily by patent protections and market competition. As patent protection wanes, a substantial price decline is expected due to the increased prevalence of generic alternatives, aligning with historical trends observed in similar drugs.
Investors and pharmaceutical manufacturers should monitor patent statuses, regulatory developments, and competitive dynamics to capitalize on future market movements and optimize pricing strategies.
Key Takeaways
- The drug's current market position is heavily favorable due to patent protection, allowing premium pricing.
- Patent expiration or challenges are pivotal events that will significantly influence future price trajectories.
- Generic competition is poised to reduce prices by approximately 30-60% within 2-3 years post-patent expiry.
- Market demand remains robust for HIV therapies, especially in regions with high prevalence.
- Strategic investments in biosimilar and combination drug development are recommended to capture future market share.
FAQs
1. How does patent expiry impact the pricing of NDC 45861-0073?
Patent expiry typically enables generic manufacturers to enter the market, leading to increased competition and a sharp decline in drug prices, often by 30-60% or more within a few years.
2. Are there upcoming regulatory changes that could affect the market for this drug?
Regulatory shifts, such as updates to HIV treatment guidelines or approvals for biosimilars, can influence demand and pricing. Continuous monitoring of FDA, EMA, and other agencies is essential.
3. Which markets present the most growth opportunities for this drug?
Emerging markets with rising HIV prevalence, evolving healthcare infrastructure, and patent protections offer the most near-term growth potential.
4. How does the safety and efficacy profile of the drug influence its marketability?
A favorable safety and efficacy profile promotes higher formulary inclusion and reimbursement rates, supporting higher prices and sustained market share.
5. When should stakeholders anticipate significant price reductions?
Major price reductions are expected post-patent expiration, typically within 3-5 years, depending on patent litigation outcomes and market dynamics.
References
- FDA Orange Book
- Research, Market Analysis Reports on HIV Drugs (2022)
- Patent and Regulatory Data from IP and FDA sources
