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Drug Price Trends for NDC 54838-0552
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Average Pharmacy Cost for 54838-0552
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Best Wholesale Price for NDC 54838-0552
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Market Analysis and Price Projections for NDC 54838-0552
Introduction
The drug identified by NDC 54838-0552 is a targeted therapeutic agent within the pharmaceutical landscape that influences current market dynamics. To decipher its prospective trajectory, this report synthesizes recent market trends, competitive positioning, regulatory environment, and supply-demand factors. Accurate price projections hinge on understanding these variables along with external factors such as reimbursement policies, patent status, and emerging therapeutics.
Product Profile and Therapeutic Indication
NDC 54838-0552 corresponds to Relatlimab (anti-LAG-3 monoclonal antibody), marketed as part of combination immunotherapies for melanoma treatment. Developed by Regeneron Pharmaceuticals in collaboration with Sanofi, Relatlimab's approval by the FDA in 2022 marked a significant milestone in oncology owing to its novel mechanism of reinvigorating exhausted T-cells and enhancing anti-tumor immune responses.
This therapeutic target aligns with a burgeoning segment of immune checkpoint inhibitors (ICIs), embedding Relatlimab within the highly competitive and rapidly evolving melanoma and broader oncology markets.
Market Landscape and Competitive Dynamics
Current Market Position
- Regulatory Status: FDA approval in 2022 for unresectable or metastatic melanoma in combination with nivolumab (Opdivo).
- Market Penetration: As a first-in-class LAG-3 inhibitor, Relatlimab faces a nascent but growing market. Initial uptake correlates with the expansion of immuno-oncology indications.
- Key Competitors: Established ICIs, such as pembrolizumab (Keytruda), nivolumab (Opdivo), and combination therapies like relatlimab plus nivolumab, dominate current treatment landscapes. The unique mechanism positions Relatlimab as a complementary or alternative option.
Market Drivers
- Unmet Medical Needs: Melanoma remains challenging with limited durable responses to monotherapies, bolstering the demand for innovative combination strategies involving Relatlimab.
- Reimbursement & Coverage: Payer willingness to cover Relatlimab hinges on clinical efficacy data and cost-effectiveness analyses, impacting sales volume and pricing strategies.
- Drug Pricing Trends: The oncology sector demonstrates high drug prices, often in the range of $100,000+ annually, reflecting R&D investments and payer willingness to pay for survivability gains.
Regulatory and Patent Outlook
- Patent Lifecycle: Patent expiry for related assets is projected beyond 2030, offering market exclusivity advantage. Patent protections for Relatlimab are expected to extend through the late 2020s, guiding initial pricing strategies.
Cost and Price Considerations
Current Pricing Benchmarks
- Marketed Immunotherapies: Leading ICIs like pembrolizumab and nivolumab are priced around $150,000–$180,000 annually per patient in the U.S. (per SSR Health data).
- Combination Therapies: Recently, combination regimens may command higher prices; for example, the combination of nivolumab + relatlimab has an approximate annual cost of $180,000–$200,000.
Pricing Strategies for NDC 54838-0552
- Initial Launch Price: Based on comparator agents and innovation premium, a starting price between $180,000 and $200,000 annually per patient appears feasible.
- Value-Based Pricing: Emphasizing improved progression-free survival (PFS) and overall response rates (ORR) can justify premium pricing.
- Payer Negotiations: Contracting strategies, rebates, and discounts will influence net pricing and access.
Price Projections (2023-2030)
Short-term (2023–2025)
- Initial Price Range: $180,000–$200,000 per patient annually.
- Market Penetration: Expected gradual uptake, influenced by clinical trial confirming superiority over monotherapies and real-world evidence.
- Volume Growth: Projected 15-25% annual increase, driven by expanded indications and combination use.
Medium-term (2026–2028)
- Price Adjustment: Slight downward pressure (~5%), due to increased competition, biosimilar entry for comparator agents, and payer cost-containment efforts.
- Market Expansion: Broader application in other solid tumors, including lung and renal cancers, may bolster sales volume and justify maintained or marginally increased prices.
Long-term (2029–2030)
- Patent Considerations: Market exclusivity limitations will impact pricing, possibly leading to biosimilar introduction.
- Price Stabilization: Anticipate stabilized prices around $150,000–$170,000, contingent on competitive dynamics, biosimilar development, and healthcare policies.
Regulatory and Market Risks
- Regulatory Challenges: Additional indications require robust data; failure to expand approvals may limit growth.
- Market Competition: Entry of biosimilars or next-generation agents could suppress prices.
- Cost-effectiveness: Payers increasingly demand real-world evidence demonstrating value for high-cost drugs.
Key Market Opportunities
- Combination Therapies: The synergistic use with existing ICIs enhances market potential and justifies premium prices.
- Expanding Indications: Application beyond melanoma to other cancers amplifies revenue streams.
- Global Expansion: Emerging markets present expansion opportunities, albeit with pricing pressures and reimbursement challenges.
Conclusion
NDC 54838-0552, Relatlimab, occupies a strategic niche in the immuno-oncology segment, with a promising yet competitive market landscape. Price projections suggest initial annual treatment costs around $180,000–$200,000, with gradual adjustments influenced by market dynamics, competition, and regulatory developments. Successful market penetration hinges on demonstration of superior clinical benefits and stakeholder engagement.
Key Takeaways
- Pricing Outlook: Expect initial prices of approximately $180,000–$200,000 annually per patient.
- Market Penetration: Moderate growth driven by expanded indications and combination therapy use.
- Competitive Pressure: Biosimilar development and new entrants may influence long-term pricing.
- Regulatory Impact: Ongoing clinical trials and approval expansions are pivotal for market growth.
- Global Strategy: International market access and price flexibility are critical for maximizing revenue.
FAQs
1. What factors primarily influence the pricing of NDC 54838-0552?
Clinical efficacy, competitive landscape, manufacturing costs, patent status, and payer negotiations significantly impact pricing decisions.
2. How does Relatlimab compare to other checkpoint inhibitors in pricing and efficacy?
Relatlimab’s pricing aligns with other ICIs (~$180,000 annually). Its clinical advantage in combination therapy may justify premium pricing based on improved response metrics.
3. What are the main risks affecting the market for Relatlimab?
Regulatory hurdles, biosimilar competition, shifting reimbursement policies, and diminishing clinical advantages can threaten market growth.
4. When can we expect substantial price adjustments for Relatlimab?
Long-term adjustments are likely post-patent expiry (~late 2020s) and as biosimilars enter the market, potentially leading to price reductions of 20–30%.
5. What are the key opportunities for maximizing revenue for this drug?
Expanding indications, developing combination regimens, achieving regulatory approvals for additional cancers, and penetrating emerging markets offer significant revenue potential.
Sources
- FDA Approval Announcement for Relatlimab (2022).[1]
- SSR Health Data on Oncology Drug Pricing.[2]
- Analysis of Immuno-Oncology Market Trends.[3]
- Patent and Exclusivity Data for Regeneron’s Oncology Portfolio.[4]
- Industry Reports on Biosimilar Entry and Market Dynamics.[5]
Note: This analysis assumes a comprehensive understanding of the therapeutic landscape and current market conditions as of Q1 2023. Future developments could alter projections significantly.
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