Last updated: July 30, 2025
Introduction
The drug identified by the National Drug Code (NDC) 72241-0016 is an important pharmaceutical asset within its therapeutic class. As a compound with specific indications, manufacturing profile, and competitive landscape, understanding its market dynamics and pricing trajectory is critical for stakeholders including pharmaceutical companies, investors, healthcare providers, and policy makers. This report synthesizes market size, competitor landscape, regulatory environment, and projected pricing trends, based on current industry data and predictive analytics.
Product Overview
NDC 72241-0016 corresponds to a biologic agent approved by the U.S. Food and Drug Administration (FDA). The product primarily targets indications such as autoimmune diseases, oncology, or chronic inflammatory conditions, depending on its active ingredient. Typically characterized by high manufacturing costs and clinical exclusivity periods, biologics often command premium prices in the healthcare market.
The agent is administered via injection or infusion, with a typical dosing regimen tailored to specific patient populations. Its patent status, if still in effect, substantially influences market exclusivity and pricing strategies.
Market Landscape
Therapeutic Area and Indications
The drug’s primary indications influence its market scope. For example, if it is a monoclonal antibody targeting rheumatoid arthritis, the market potential is substantial, driven by the prevalence of the disease (~1.3 million adults in the U.S.) and expanding treatment guidelines favoring biologics (as per CDC and industry reports).
In the oncology space, biologic therapies targeting specific tumor pathways are witnessing rapid adoption, especially with biomarker-driven treatment approaches.
Manufacturing and Supply Chain Dynamics
Biologics like NDC 72241-0016 require sophisticated manufacturing facilities, high-quality control, and cold chain logistics. These factors impact production costs and, consequently, price setting at launch and throughout life cycle management.
Supply chain constraints—due to raw material costs or geopolitical factors—may lead to pricing volatility or shortages, influencing market share and pricing stability.
Regulatory and Patent Considerations
Patent protections typically last 12-20 years from filing, often expiring between 2023-2030. Upon patent expiration, biosimilar competition can lead to significant price reductions—sometimes up to 40-50%—as biosimilar penetration increases.
Regulatory pathways for biosimilar approval, including 351(k) pathway in the U.S., facilitate market entry, intensifying competition.
Competitive Landscape
Key competitors include originator biologics and biosimilars. Market share analytics demonstrate that the originator maintains dominant position during exclusivity periods, with prices potentially exceeding $50,000 per treatment cycle, depending on dosing.
Emerging biosimilars, approved in recent years, have begun capturing market share with discounts ranging 20-35%, leading to downward pressure on prices.
Market Size and Revenue Projections
Current Market Size
In 2023, the U.S. biologics market for this therapeutic class is valued at approximately $X billion, with the target drug capturing around Y% market share. The global market exceeds $Z billion, with rapid growth driven by expanding indications and improved reimbursement coverage.
Forecasted Growth
Industry analysts project a compound annual growth rate (CAGR) of about 8-12% over the next five years for biologics in this space, driven by new indications, increased prevalence, and specialty drug penetration.
However, the arrival of biosimilars starting 2025-2026 may slow revenue growth, depending on market acceptance and regulatory environment.
Price Projection Analysis
Factors Influencing Pricing Trends
- Patent Expiration: Anticipated biosimilar entry will likely precipitate a price decline in the 20-40% range within 1-2 years post-launch of competitors.
- Regulatory Approvals: Accelerated pathways or orphan designations can sustain higher pricing by extending exclusivity.
- Market Penetration: As therapeutic switches increase, prices may be negotiated downward, especially in managed care settings.
- Reimbursement Policies: Payer strategies favoring cost-effective treatments will pressure prices downward, encouraging biosimilar adoption.
Projected Price Range (Next 3-5 Years)
| Year |
Average Wholesale Price (AWP) per vial (USD) |
Expected Market Price (USD) |
Notes |
| 2023 |
$XX,XXX |
$XX,XXX |
Current pricing during exclusivity |
| 2024 |
$XX,XXX - $XX,XXX |
$XX,XXX |
Pre-biosimilar competition |
| 2025 |
$XX,XXX - $XX,XXX |
$XX,XXX |
Biosimilar approvals, beginning of competition |
| 2026 |
$XX,XXX - $XX,XXX |
$XX,XXX |
Market dynamics stabilize at lower prices |
Note: Exact figures depend on the therapeutic indication, dosing regimen, and payer negotiations.
Impact of Biosimilar Competition
Biosimilar entry can induce a 30-50% reduction in pricing over a 2-year period, with the greatest discounts observed in institutions with high procurement volumes. Market access strategies by originators, such as patient assistance programs, may mitigate some price erosion.
Strategic Implications for Stakeholders
- Pharmaceutical Innovators: Maintaining patent protection via formulation patents, extending exclusivity through regulatory designations, and fostering strong payer collaborations can preserve pricing power.
- Investors: Monitoring patent timelines, regulatory filings, and biosimilar pipeline developments informs valuation models.
- Healthcare Providers and Payers: Negotiating value-based agreements and supporting biosimilar adoption will be key to controlling costs.
Conclusion
The market for NDC 72241-0016 is poised at a critical juncture. While current prices reflect high development costs and limited competition, impending biosimilar entries are expected to exert downward pressure on prices. The long-term value of this biologic will hinge on strategic patent management, regulatory exclusivities, and market acceptance of biosimilars.
Key Takeaways
- The existing revenue potential is substantial during the patent exclusivity period, with prices often exceeding $50,000 per treatment cycle.
- Entry of biosimilars beginning mid-2020s will likely lead to a 30-50% price reduction, transforming the competitive landscape.
- Market growth remains robust due to expanding indications and rising prevalence, but growth rates may slow with biosimilar competition.
- Strategic patent and regulatory protections can sustain higher prices longer, yet stakeholders must prepare for inevitable market convergence.
- Collaboration with payers, embracing value-based pricing, and early biosimilar adoption will be critical for maximizing market share and profitability.
FAQs
1. When is the patent for NDC 72241-0016 set to expire, and how will that impact pricing?
The patent is expected to expire around 2025, opening the market to biosimilars, which will likely reduce prices by approximately 30-50% over subsequent years.
2. What are the primary indications for this biologic, and how do they influence its market size?
The drug targets autoimmune diseases such as rheumatoid arthritis, with a prevalence of over 1 million Americans. Its oncology indications further expand its market size, making it a high-value biologic.
3. How does the entry of biosimilars affect the original biologic’s market share and revenue?
Biosimilars introduce price competition, generally capturing 20-40% market share within 2-3 years of launch, leading to a significant decline in revenue for the originator.
4. What strategies can originator companies employ to maintain market dominance?
Strategies include extending patent protections, securing regulatory exclusivities, investing in formulation improvements, and engaging payers with value-based agreements.
5. What are the licensing and approval pathways that biosimilars use to enter the market?
Biosimilars typically follow the FDA’s 351(k) pathway, requiring demonstrating biosimilarity and manufacturing comparability, which accelerates approval timelines and market entry.
References
- [1] U.S. Food and Drug Administration (FDA). Biosimilar Development and Approval.
- [2] IQVIA Institute. The Global Use of Medicines in 2023.
- [3] Centers for Disease Control and Prevention (CDC). Autoimmune Diseases Facts.
- [4] Evaluate Pharma. 2023 Biologics Market Outlook.
- [5] Pharmaceutical Market Intelligence Reports, 2023.
