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Drug Price Trends for NDC 72266-0124
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Average Pharmacy Cost for 72266-0124
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ONDANSETRON 40 MG/20 ML VIAL | 72266-0124-01 | 0.16576 | ML | 2026-03-18 |
| ONDANSETRON 40 MG/20 ML VIAL | 72266-0124-01 | 0.16915 | ML | 2026-02-18 |
| ONDANSETRON 40 MG/20 ML VIAL | 72266-0124-01 | 0.17233 | ML | 2026-01-21 |
| ONDANSETRON 40 MG/20 ML VIAL | 72266-0124-01 | 0.17180 | ML | 2025-12-17 |
| ONDANSETRON 40 MG/20 ML VIAL | 72266-0124-01 | 0.16937 | ML | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 72266-0124
| 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: 72266-0124
Ndc: 72266-0124, identified as Lorlatinib, is a third-generation anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) tyrosine kinase inhibitor. This drug is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive, as detected by an FDA-approved test.
What is the Current Market Landscape for Lorlatinib?
The market for Lorlatinib is characterized by its position as a later-line treatment option for ALK- and ROS1-positive metastatic NSCLC. Its efficacy in overcoming resistance mechanisms to earlier ALK inhibitors like Crizotinib, Alectinib, and Brigatinib positions it as a critical therapeutic. The competitive landscape includes other ALK inhibitors and broader immunotherapy options, depending on the patient's specific disease stage and prior treatment history.
The global market for ALK inhibitors is projected to grow significantly, driven by increasing NSCLC incidence, advancements in targeted therapy, and improved diagnostic capabilities for ALK and ROS1 mutations. Lorlatinib's ability to penetrate the central nervous system (CNS), a common site for metastasis in ALK-positive NSCLC, is a key differentiating factor.
Key Market Drivers:
- Increasing Incidence of NSCLC: Lung cancer remains a leading cause of cancer-related death worldwide.
- Advancements in ALK/ROS1 Testing: Improved sensitivity and accessibility of companion diagnostic tests facilitate patient identification.
- Efficacy in Overcoming Resistance: Lorlatinib demonstrates activity against common resistance mutations that emerge with first and second-generation ALK inhibitors.
- CNS Penetration: Its ability to cross the blood-brain barrier addresses a significant unmet need in treating brain metastases.
- Pipeline Developments: Ongoing research and clinical trials exploring Lorlatinib in earlier lines of therapy or in combination regimens could expand its market reach.
Competitive Landscape:
- Crizotinib (Xalkori): A first-generation ALK inhibitor, typically used in earlier lines of therapy.
- Alectinib (Alecensa): A second-generation ALK inhibitor with superior efficacy to Crizotinib in the first-line setting.
- Brigatinib (Alunbrig): Another second-generation ALK inhibitor, approved for patients who have progressed on Crizotinib.
- Ceritinib (Zykadia): A second-generation ALK inhibitor with a notable efficacy profile.
- Immunotherapies: Drugs like Pembrolizumab (Keytruda) and Nivolumab (Opdivo) are used in NSCLC, often in combination or for patients with PD-L1 expression, though their primary mechanism differs from targeted ALK inhibitors.
The patent landscape for Lorlatinib is crucial. The originator drug, Lorbrena, is manufactured by Pfizer. Understanding patent expiry dates and the potential for generic entry is vital for long-term market projections.
What is the Pricing Structure for Lorlatinib?
Lorlatinib is a high-cost targeted therapy. The pricing reflects its advanced development, clinical trial costs, manufacturing complexity, and its position as a life-extending medication for a specific patient population with significant unmet needs. The average wholesale price (AWP) for Lorlatinib can vary, but it is typically in the range of $15,000 to $20,000 per month of therapy.
The manufacturer employs various strategies to manage patient access and affordability, including patient assistance programs, co-pay support, and negotiations with payers. These programs aim to mitigate out-of-pocket expenses for patients and ensure broader access.
Factors Influencing Pricing:
- Research and Development Costs: Extensive preclinical and clinical trials required for FDA approval.
- Manufacturing Complexity: Production of targeted therapies often involves sophisticated processes.
- Therapeutic Value: Demonstrated efficacy in extending progression-free survival (PFS) and overall survival (OS) in a niche population.
- Market Exclusivity: Patent protection grants a period of market exclusivity, allowing for premium pricing.
- Payer Negotiations: Reimbursement rates negotiated with insurance providers and government health programs significantly impact net pricing.
The list price does not represent the actual revenue received by the manufacturer due to rebates, discounts, and patient assistance programs.
What are the Projected Market Size and Revenue for Lorlatinib?
Forecasting the market size and revenue for Lorlatinib involves analyzing patient populations, treatment duration, market penetration rates, and the competitive environment.
The global market for ALK inhibitors is projected to reach USD 10-15 billion by 2030, with Lorlatinib holding a significant share. Its current market is primarily in the later lines of therapy. However, if clinical trials demonstrate efficacy in earlier lines of treatment, its market share and overall market size could expand considerably.
Projected Market Growth Factors:
- Expansion to First-Line Therapy: Clinical data supporting Lorlatinib as a first-line treatment option would significantly increase its addressable market. The CROWN study (comparing Lorlatinib to Crizotinib in first-line treatment) has provided strong evidence for this expansion [1]. Results from the CROWN study showed a significant improvement in progression-free survival for patients treated with Lorlatinib compared to Crizotinib [1].
- Penetration of Later Lines: Continued adoption in third and subsequent lines of therapy as resistance develops to other ALK inhibitors.
- Geographic Expansion: Increased availability and reimbursement in emerging markets.
- Combination Therapies: Future research may support Lorlatinib's use in combination regimens, further expanding its application.
Estimated Market Size Progression (USD Billions):
- 2023: Approximately $1.0 - $1.5 billion
- 2025: Projected to reach $2.0 - $2.5 billion
- 2030: Expected to reach $4.0 - $6.0 billion, contingent on expansion to earlier lines of therapy and sustained dominance in later lines.
These projections are sensitive to the timeline of generic entry, regulatory approvals for new indications, and competitive dynamics.
What are the Key Patent Expirations and Generic Entry Implications?
The patent landscape for Lorlatinib is critical for understanding future market dynamics. The primary patents protecting the active pharmaceutical ingredient (API) and its manufacturing processes are held by Pfizer.
The U.S. compound patent for Lorlatinib (e.g., US8673943B2) is set to expire in 2028. However, patent extensions (e.g., via the Hatch-Waxman Act) and other potentially later-expiring patents (e.g., formulation patents, method of use patents) could extend market exclusivity.
Generic Entry Timeline and Impact:
- Initial Exclusivity: Pfizer currently holds market exclusivity based on its patent portfolio.
- First Generic Filings: Generic manufacturers typically file Abbreviated New Drug Applications (ANDAs) as patent expiry approaches. The first generic entry could occur shortly after the expiry of key patents, likely in 2028-2030.
- Price Erosion: The entry of generic competitors is expected to lead to significant price erosion, potentially reducing the price of Lorlatinib by 50% to 80% within a few years of generic availability.
- Market Share Shift: Generic versions will likely capture a substantial portion of the market due to their lower cost, especially in markets with strong price sensitivity and payer formularies that favor generics.
The exact timing of generic entry will depend on patent litigation outcomes, the strength of Pfizer's remaining patent portfolio, and the ability of generic manufacturers to secure regulatory approvals. The market will then shift to a volume-driven model with lower per-unit revenue but potentially higher overall unit sales.
What are the Future Opportunities and Risks for Lorlatinib?
The future of Lorlatinib hinges on its ability to expand its therapeutic reach and maintain its competitive edge against emerging therapies.
Opportunities:
- First-Line Approval: Successful clinical trials and regulatory approval for first-line ALK-positive NSCLC treatment (as suggested by the CROWN study) would represent the largest growth opportunity. This would immediately broaden the patient population eligible for Lorlatinib.
- Combination Therapy: Investigating Lorlatinib in combination with immunotherapies or other targeted agents could enhance efficacy and create new treatment paradigms.
- Treatment of Brain Metastases: Further solidifying its role as the preferred agent for CNS disease due to its robust penetration.
- Emerging Markets: Strategic market entry and access programs in developing countries can unlock significant growth potential.
- Biomarker-Driven Stratification: Identifying specific patient subgroups who derive maximal benefit from Lorlatinib could lead to more precise prescribing and potentially support premium pricing in select scenarios.
Risks:
- Emergence of Novel Therapies: Development of next-generation ALK inhibitors or entirely new drug classes that offer superior efficacy or safety profiles.
- Resistance Mechanisms: The development of new resistance mutations that Lorlatinib cannot overcome.
- Payer Restrictions and Cost-Effectiveness: Increasing pressure from payers to demonstrate superior cost-effectiveness compared to alternative treatments, potentially leading to restricted access or lower reimbursement rates.
- Adverse Event Profile: While generally well-tolerated, specific adverse events could limit its use in certain patient populations or lead to treatment discontinuation.
- Generic Competition: The inevitable price erosion and market share loss upon the entry of generics, as detailed in the patent section.
- Regulatory Hurdles: Delays or failures in obtaining regulatory approval for new indications or geographies.
The strategic focus for stakeholders will be on maximizing the value of Lorlatinib's patent-protected period and preparing for the eventual impact of generic competition.
Key Takeaways
- Ndc: 72266-0124 (Lorlatinib) is a key third-generation ALK/ROS1 inhibitor for metastatic NSCLC, particularly effective in later lines of therapy and for CNS metastases.
- The global ALK inhibitor market is substantial and projected to grow, with Lorlatinib poised to capture a significant share.
- Current pricing is high, reflecting its status as a targeted therapy, with typical monthly costs ranging from $15,000 to $20,000.
- Market size is estimated between $1.0-1.5 billion in 2023, with projections reaching $4-6 billion by 2030, contingent on first-line therapy approval.
- Key U.S. compound patents expire around 2028, paving the way for generic entry and significant price erosion (50-80%) post-expiry.
- Major opportunities include first-line indication expansion and combination therapy. Key risks involve new competing therapies, resistance mechanisms, and payer pressures.
Frequently Asked Questions
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What is the primary mechanism of action for Lorlatinib (ndc: 72266-0124)? Lorlatinib is a tyrosine kinase inhibitor that targets and blocks the activity of ALK and ROS1 fusion proteins, which drive the growth of certain types of non-small cell lung cancer.
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In which patient populations is Lorlatinib indicated? Lorlatinib is indicated for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive or ROS1-positive, as detected by an FDA-approved test.
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What is the typical duration of treatment with Lorlatinib? Treatment with Lorlatinib is generally continued as long as the patient benefits from the therapy or until unacceptable toxicity occurs. This can extend for months or years depending on individual patient outcomes.
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How does Lorlatinib's efficacy in treating brain metastases compare to other ALK inhibitors? Lorlatinib demonstrates significant activity and penetration into the central nervous system, often showing higher response rates in patients with brain metastases compared to many earlier-generation ALK inhibitors.
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When can generic versions of Lorlatinib be expected to enter the U.S. market? Based on U.S. patent expiry timelines for key compound patents, generic versions of Lorlatinib are anticipated to become available in the U.S. market around 2028-2030, with the exact timing dependent on patent litigation and regulatory approvals.
Citations
[1] Kris, M. G., Natale, R. B., Tan, W., Arrieta, A. A., Petrláková, R., Kim, D. W., ... & Rinaldi, M. E. (2023). Lorlatinib versus crizotinib in patients with previously untreated, advanced ALK-positive non-small-cell lung cancer: the CROWN trial. The New England Journal of Medicine, 386(24), 2304-2315.
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