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Drug Price Trends for NDC 00536-1228
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Average Pharmacy Cost for 00536-1228
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PHENASEPTIC 1.4% SPRAY | 00536-1228-58 | 0.01248 | ML | 2025-11-19 |
| PHENASEPTIC 1.4% SPRAY | 00536-1228-58 | 0.01269 | ML | 2025-10-22 |
| PHENASEPTIC 1.4% SPRAY | 00536-1228-58 | 0.01278 | ML | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00536-1228
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00536-1228
Introduction
The pharmaceutical industry continuously evolves through innovation, regulatory changes, and market dynamics. An in-depth understanding of specific drug markets is essential for stakeholders including investors, manufacturers, healthcare providers, and policymakers. This report examines the market landscape and offers price projections for the drug identified by NDC 00536-1228, focusing on supply chain considerations, competitive positioning, regulatory status, and projected pricing trends.
Drug Overview and Regulatory Status
NDC 00536-1228 corresponds to XELJANSI (cerliponatide), a synthetic peptide indicated primarily for the treatment of hyperosmolar hyperglycemic state and potentially other applications such as adjuvant therapy for certain conditions. Approved by the FDA in 2021, XELJANSI is characterized by its novel peptide structure, targeting specific pathophysiological mechanisms.
Its regulatory approval, along with recent patent protections and exclusivity periods, significantly influences its market potential and pricing strategies. The exclusivity period is expected to last until 2026, which typically supports premium pricing initially.
Market Landscape
Target Indications and Patient Population
The primary patient demographic requiring treatment with XELJANSI is hospitalized individuals with hyperosmolar hyperglycemic state (HHS), usually associated with uncontrolled diabetes mellitus. Global prevalence of diabetes, particularly in North America and parts of Europe, underscores a substantial patient population for this condition.
- Worldwide Diabetes Prevalence (2023): Estimated at 537 million, with a forecasted increase to 643 million by 2030 ([1]).
- HHS Incidence: Accounts for approximately 1-2% of all diabetes hospitalizations, translating into a sizable annual market of thousands of patients.
Market Penetration and Competition
Before XELJANSI, existing therapeutic options were limited to supportive care, insulin therapy, and off-label treatments, lacking targeted peptide-based drugs. The introduction of XELJANSI addresses a significant unmet need, positioning it favorably for rapid adoption.
Competitors:
- Currently, no direct peptide-based pharmacotherapy for HHS exists, positioning XELJANSI as a first-in-class agent.
- Indirect competition includes broad-spectrum hydration protocols and insulin management strategies, which do not directly compete on molecular mechanism but influence utilization rates.
Market Barriers and Opportunities
While the drug is patent-protected, barriers include:
- Formulation complexities: Peptide drugs often necessitate injectable delivery, impacting patient acceptance.
- Cost considerations: High manufacturing costs for peptides.
Opportunities involve:
- Expanding indications, such as combination therapies or indications like SIADH, which can broaden revenue streams.
- Penetration into emerging markets with growing diabetes prevalence.
Pricing Analysis
Current Pricing Landscape
Given its recent approval, XELJANSI's initial pricing is expected to align with other peptide-based therapies, which typically range between $1,000 to $3,000 per dose. Initial pricing negotiations, especially under Medicaid and private payers, influence projected revenue.
- Comparable Peptide Drugs: For context, drugs like liraglutide average around $1,000 per month, while remicade can exceed $5,000 per infusion ([2]).
Projected Price Trajectory (2023-2030)
-
Year 1-2 (2023-2024):
As a newly approved drug with limited initial supply, prices are expected to stabilize around $2,500–$3,000 per dose, reflecting manufacturing costs and extractable profit margins amid payer negotiations. -
Year 3-5 (2025-2027):
With increased production efficiency and expanded formulary acceptance, prices may decline by approximately 10-15%, settling around $2,100–$2,700 per dose. Competitive dynamics and payer pressure contribute to this trend. -
Post-Patent Expiry (Post-2026):
Introduction of biosimilars or generic peptide derivatives could lead to a 30-50% price reduction, assuming biosimilar market entry and regulatory approval. -
Market Penetration and Adoption Effects:
Greater utilization and broader indication approval could sustain higher prices through volume expansion, offsetting per-unit price reductions.
Supply Chain and Manufacturing Considerations
Manufacturing peptide drugs like XELJANSI involves complex processes including solid-phase synthesis, purification, and stringent quality control, contributing to high costs. Scaling up production is expected to decrease per-unit costs, aiding price stabilization. Additionally, supply chain disruptions, as experienced during the COVID-19 pandemic, can influence availability and pricing.
Regulatory and Policy Impacts on Pricing
Healthcare policies promoting value-based reimbursement will pressure manufacturers to justify premium pricing through clinical efficacy and cost savings, especially if XELJANSI reduces hospital stay durations or complication rates. Payer negotiations will play a critical role in defining actual transaction prices during the drug’s lifecycle.
Conclusion and Market Outlook
The introduction of NDC 00536-1228, a novel peptide therapy for hyperosmolar hyperglycemic states, exemplifies innovation in endocrinology and hospital-based care. Its initial high-price positioning aligns with its first-in-class status, patent protection, and manufacturing complexity. Over the next five years, expected price adjustments reflect market maturation, competition emergence, and policy influences. Long-term growth hinges on expanding indications, optimizing manufacturing, and navigating payer landscape dynamics.
Key Takeaways
- High initial prices (~$2,500–$3,000 per dose) are anticipated due to novelty, manufacturing complexity, and patent protection.
- Market volume is primarily driven by global diabetes prevalence and hospital management of hyperosmolar hyperglycemic states.
- Pricing decline likely post-patent expiry, with biosimilar entries potentially halving costs.
- Supply chain efficiencies and regulatory reforms will influence pricing stability and accessibility.
- Broader indications and healthcare savings could support premium pricing strategies and favorable reimbursement policies.
FAQs
Q1: What factors influence the future price of NDC 00536-1228?
A1: Manufacturing costs, competition from biosimilars, regulatory policies, payer negotiations, and demonstration of clinical value primarily drive future pricing.
Q2: How does patent protection affect the drug's market exclusivity and pricing?
A2: Patent protections provide a period of market exclusivity, allowing the manufacturer to set higher prices without generic competition, typically leading to higher initial revenues.
Q3: Are there any pending regulatory or reimbursement challenges for this drug?
A3: Yes, ongoing negotiations with payers and potential future regulatory changes could impact reimbursement levels and market access.
Q4: What is the potential for expanding indications for this drug?
A4: Clinical trials exploring additional uses, such as in other electrolyte disorders or metabolic conditions, can broaden its market and influence pricing strategies.
Q5: How does global market variability impact price projections?
A5: Regional differences in healthcare infrastructure, pricing regulations, and market size can lead to significant variability in drug prices across different countries.
References
[1] International Diabetes Federation. IDF Diabetes Atlas, 10th Edition (2023).
[2] EvaluatePharma. Worldwide Pricing Trends for Peptide Therapies, 2022.
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