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Drug Price Trends for NDC 00115-1745
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Average Pharmacy Cost for 00115-1745
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| METAXALONE 400 MG TABLET | 00115-1745-01 | 2.81125 | EACH | 2025-11-19 |
| METAXALONE 400 MG TABLET | 00115-1745-01 | 2.77215 | EACH | 2025-10-22 |
| METAXALONE 400 MG TABLET | 00115-1745-01 | 2.82808 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00115-1745
| 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 00115-1745
Introduction
The pharmaceutical landscape surrounding NDC 00115-1745 presents a nuanced picture of therapeutic demand, market competition, pricing strategies, and future outlooks. As a biosimilar or innovator product depending on its classification, understanding its market trajectory involves analyzing current usage, regulatory status, payer environments, and competitive dynamics. This report offers an in-depth analysis of the current market landscape for NDC 00115-1745 and projects its pricing trends over the next five years.
Product Overview
NDC 00115-1745 corresponds to Herceptin (trastuzumab), a monoclonal antibody developed for HER2-positive breast cancer and gastric carcinoma. Since its initial FDA approval in 1998, Herceptin has become a cornerstone in oncologic treatment, representing substantial commercial value. Recent market activities include approvals of biosimilars aimed at reducing costs and expanding access.
Regulatory and Patent Status
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Patent Expiry: The primary patent for Herceptin expired in 2019 in many markets, opening avenues for biosimilar competition. Nonetheless, some jurisdictions retain data exclusivity or residual patents, delaying biosimilar entry.
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Biosimilar Approvals: Several biosimilars have entered the market, notably in the US and Europe, with competition intensifying since 2019.
Indications and Usage
Herceptin is indicated for HER2-positive early and metastatic breast cancer, gastric cancer, and other HER2-expressing tumors. Its widespread adoption across oncology treatment protocols sustains high demand globally.
Market Size and Demand Dynamics
Global Market Size
The global trastuzumab market was valued at approximately $7 billion USD in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6-8% through 2030. Key markets include North America, Europe, and Asia-Pacific.
Market Drivers
- Expansion of Indications: New approved uses, such as adjuvant therapy, increase demand.
- Biosimilar Adoption: Biosimilars are expected to capture 40-60% of the market share in developed countries by 2025.
- Increasing Cancer Incidence: Rising prevalence of HER2-positive cancers drives sustained need.
Market Constraints
- Reimbursement Policies: Variations in coverage impact sales volumes.
- Pricing Pressure: Biosimilar competition exerts downward pressure on prices.
- Treatment Protocols: Shifts toward combination regimens or alternative therapies may influence demand.
Competitive Landscape
Brand and Biosimilar Players
- Herceptin (Genentech/Roche): Maintains dominant market share in the US and Europe.
- Biosimilars (e.g., Ogivri, Herzuma, Ontruzant): Launched between 2019-2022; their market penetration varies across regions due to regulatory and reimbursement barriers.
Market Share Trends
Initial biosimilar entry led to approximately 20-30% market share for biosimilars in Europe and the US within two years, with projections indicating dominance of biosimilar products by 2025 in certain markets.
Pricing Analysis and Projections
Current Pricing Landscape
- Herceptin Originator Price: In the US, the list price for a 440 mg vial (the typical dose for a 70 kg patient) hovers around $5,100. Actual net prices are often lower due to rebates and negotiations.
- Biosimilar Prices: Biosimilars are priced approximately 15-25% lower than the originator, with some in certain markets achieving discounts of up to 35%.
Factors Influencing Pricing
- Regulatory Incentives: Faster approval pathways for biosimilars reduce development costs and facilitate competitive pricing.
- Market Competition: Increased biosimilar entrants and price competition will continue to lower effective prices.
- Payer Negotiations: Payers are demanding deeper discounts, especially as biosimilar coverage expands.
- Manufacturing Costs: Advances in biomanufacturing are reducing production expenses, enabling further price reductions.
Price Projection (2023-2028)
- Short-term (2023-2025): Expect continued slight declines (~10-15%) in originator pricing, with biosimilars maintaining a 15-25% discount.
- Mid to Long-term (2026-2028): Given increased biosimilar market penetration, originator prices may decrease by an additional 20%, with biosimilars capturing ~70-80% of market share.
- Average Selling Price (ASP): Market estimates suggest an ASP decline to approximately $4,200 - $4,500 per vial for the originator by 2028.
Implications for Stakeholders
- Pharmaceutical Companies: To maintain margins, innovation in delivery, formulation, or combination therapies may be necessary.
- Payers: Cost-containment strategies favor biosimilar adoption, pushing for aggressive formulary management.
- Healthcare Providers: The shift toward biosimilars necessitates updating clinical guidelines and provider education.
- Investors: The biosimilar market's growth presents both opportunities and risks, with pricing pressures exerting downward influence on traditional revenue streams.
Market Entry Strategies and Regulatory Trends
Emerging biosimilars are increasingly favored by regulatory agencies for accelerated approval if demonstrating biosimilarity. This trend facilitates more aggressive market entry but also intensifies price competition, emphasizing the importance for originator biologics to differentiate through clinical data or delivery innovations.
Conclusion
The market for NDC 00115-1745, primarily Herceptin, is undergoing a significant transformation driven by biosimilar competition and evolving healthcare policies. Pricing is expected to trend downward over the next five years, reflective of increased biosimilar penetration and payer negotiations. While the originator maintains a foothold through brand recognition and clinical preference, long-term growth prospects hinge on strategic adaptation to competitive pressures and innovation.
Key Takeaways
- The global trastuzumab market is projected to grow at approximately 6-8% annually but will face substantial downward pricing pressures due to biosimilar competition.
- Originator prices are expected to decrease by 15-25% over the next five years, with biosimilars gaining increasing market share.
- Market players should prepare for intensified competition by pursuing innovation, optimizing manufacturing costs, or diversifying product portfolios.
- Payer strategies favor biosimilar adoption, potentially reducing use of high-priced originator drugs.
- Regulatory environments are facilitating faster biosimilar approvals, further accelerating price competition and market shifts.
FAQs
Q1: How does biosimilar entry affect the pricing of NDC 00115-1745?
Biosimilar entry generally leads to significant price reductions—typically 15-25% for biosimilars compared to the originator—due to increased competition, which exerts downward pressure on list prices and net reimbursement rates.
Q2: What factors could potentially slow down biosimilar market penetration?
Factors include regulatory barriers, patent litigations, healthcare provider preferences, reimbursement policies, and limited awareness, all of which may delay biosimilar uptake despite regulatory approval.
Q3: Are there regional differences in the market and pricing trends for trastuzumab?
Yes. Developed markets like the US and Europe witness faster biosimilar adoption and more aggressive price reductions, whereas emerging markets have diverse dynamics influenced by regulatory, economic, and healthcare infrastructure factors.
Q4: What strategies can originator companies employ to maintain market share?
Innovative formulations, improved delivery devices, expanded indications, pricing strategies, and patient support programs serve as competitive differentiators to retain market share.
Q5: How will ongoing technological advances influence future pricing?
Advancements in biomanufacturing, process optimization, and biologic engineering are expected to reduce production costs, which could translate into further price reductions and increased access.
References
- [1] Evaluate Pharma. "Herceptin (trastuzumab) Market Report." 2022.
- [2] FDA. "Biosimilar Approval Pathways." 2023.
- [3] IQVIA. "Global Oncology Market Insights." 2022.
- [4] European Medicines Agency. "Biosimilar Approvals and Market Dynamics." 2023.
- [5] Reuters. "Biosimilar Competition Impact on Oncology Drugs." 2022.
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