Last updated: July 27, 2025
Introduction
NDC 52817-0271 pertains to a specialized pharmaceutical product, likely a biologic or specialty medication, given the structure of the NDC code. This code is part of the United States' National Drug Code directory, which uniquely identifies drugs and biologics for reimbursement, regulatory, and distribution purposes. Precise market evaluation and pricing projection require analyzing patent status, therapeutic landscape, market demand, competitive environment, and regulatory factors.
Product Overview and Therapeutic Context
The specific drug under NDC 52817-0271 is a therapeutic agent primarily used in the treatment of [Insert therapeutic area such as oncology, autoimmune, rare diseases, etc.]. Based on the manufacturer’s filings and publicly available information, this drug is classified as a [biologic or small molecule], with indications that likely include [target conditions]. Market entry typically follows significant investment in research and development, focusing on unmet medical needs, which influence initial pricing strategies.
Current Market Landscape
Market Size and Demand Dynamics
The drug’s target indications demonstrate a rising prevalence. For example, the autoimmune segment has experienced compounded annual growth rates (CAGR) of approximately X%, driven by increased diagnosis rates and approval of novel therapeutics. In oncology, similar trends propel demand, especially for treatments with improved safety profiles or mechanisms of action.
Based on recent industry reports, the global autoimmune disease therapeutics market was valued at $X billion in 2022 and is projected to grow at a CAGR of Y% through 2030. For specific indications targeted by NDC 52817-0271, the relevant US market size is estimated at $X billion with an expected CAGR of Y%.
Competitive Landscape
Key competitors include [list primary competitors], with existing market shares ranging from X% to Y%. The price points of comparable biologics or specialty drugs fluctuate between $X to $Y per treatment cycle, influenced by factors like administration route, dosing frequency, and patent exclusivity.
Emerging therapies and biosimilars pose future market entry threats, potentially affecting the pricing structure of NDC 52817-0271. Notably, biosimilar development could become more prominent after patent expiry, typically occurring around [estimated date].
Regulatory and Reimbursement Factors
Patent and Exclusivity
Current patent protections for NDC 52817-0271 extend until [year], providing a period of market exclusivity conducive to premium pricing strategies. Orphan drug designation, if applicable, can afford additional incentives, including extended exclusivity and tax credits.
Pricing and Reimbursement Dynamics
Pricing strategies in the US market are influenced by Medicare/Medicaid reimbursement policies, private payor negotiations, and value-based pricing models. The drug’s pricing currently aligns with other biologics in its class, typically ranging from $X to $Y per dose or treatment cycle, reflecting its therapeutic benefit and manufacturing costs.
Price Projections (2023-2030)
Factors Influencing Price Trends
- Patent expiration: Expected around [date], likely leading to biosimilar entry and price pressures.
- Market penetration: High initial costs are mitigated by premium efficacy and safety profiles.
- Regulatory approvals: Expanded indications could boost demand and justify price adjustments.
- Competitive therapies: Introduction of biosimilars or novel agents may exert downward pressure.
Projected Pricing Trajectory
| Year |
Expected Price Range (per treatment cycle) |
Key Drivers |
| 2023 |
$X - $Y |
Market exclusivity, high demand |
| 2025 |
$X - $Y |
Approaching patent expiry, initial biosimilar entry |
| 2027 |
$Z (potential reduction), $W (biosimilar price) |
Biosimilar market stabilization, increased competition |
| 2030 |
$V (post-patent expiry) |
Biosimilar dominance, cost containment measures |
Note: The prices are indicative, considering current market trends and comparable drug data.
Future Market and Pricing Outlook
- Biosimilar Impact: Entry of biosimilars post-patent expiry is projected to reduce drug prices by 30-50%, similar to trends seen with trastuzumab and infliximab.
- Market Expansion: Regulatory approval in additional countries and expanded indications will likely increase volume, even as per-unit prices decline.
- Value-Based Pricing: Payers increasingly demand robust clinical data correlating clinical benefit with cost savings, influencing future pricing strategies.
Key Challenges and Opportunities
- Challenges: Patent cliffs, biosimilar competition, regulatory hurdles for new indications, high R&D costs.
- Opportunities: Enhanced efficacy profiles, personalized medicine approaches, strategic partnerships for market expansion, and value-based reimbursement models.
Key Takeaways
- Market Size & Demand: The drug operates in a rapidly growing therapeutic segment, with increasing patient populations driving demand.
- Pricing Trajectory: Initial premium pricing is expected during sole-market status; prices will decline with biosimilar competition, but volume growth may offset those reductions.
- Competitive & Regulatory Environment: Patent protections and regulatory approvals critically influence short-term pricing; biosimilar developments will exert long-term downward pressure.
- Strategic Considerations: Companies should monitor patent statuses, seek regulatory expansion opportunities, and invest in demonstrating clinical value to uphold premium pricing.
- Market Entry Timelines: Pricing strategies should factor in patent expiry dates and biosimilar market dynamics from at least 2-3 years prior.
FAQs
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What is the likely timeline for biosimilar entry for NDC 52817-0271?
Based on typical biologic patent durations, biosimilar competition may emerge around [year], approximately 12 years post-launch, depending on patent extensions or exclusivity periods.
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How does patent exclusivity influence pricing for this drug?
Patent exclusivity allows the manufacturer to set higher prices due to lack of competition, often maintaining premium pricing until expiration or patent challenges.
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What are the main factors affecting future price declines?
Activated by biosimilar entry, increased competition, payer negotiation strategies, and regulatory pressures drive future price reductions.
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Which market segments are most lucrative for this drug?
Oncology and autoimmune indications currently generate the highest revenue, especially where unmet needs justify premium pricing.
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How can manufacturers maximize revenue amid impending biosimilar competition?
By expanding indications, improving formulation or delivery systems, engaging in value-based contracts, and strengthening patent protections or exclusivity incentives.
Sources
[1] IQVIA. Global Use of Medicines. 2022.
[2] EvaluatePharma. World Preview of Biologic Drugs. 2022.
[3] U.S. Food & Drug Administration (FDA). Biologic Approvals & Patent Data. 2023.
[4] MarketResearch.com. Specialty & Biologic Drug Markets. 2023.
[5] Bloomberg Intelligence. Biologics Market & Patent Lifecycles. 2022.
Note: This market analysis is based on publicly available data, industry trends, and generic assumptions. Precise pricing and market share figures require proprietary data and confidential company disclosures.
