Drug Price Trends for NDC 50742-0114

Average Pharmacy Cost for 50742-0114

Drug Name	NDC	Price/Unit ($)	Unit	Date
DESIPRAMINE 50 MG TABLET	50742-0114-01	0.20252	EACH	2026-03-18
DESIPRAMINE 50 MG TABLET	50742-0114-01	0.23399	EACH	2026-02-18
DESIPRAMINE 50 MG TABLET	50742-0114-01	0.25814	EACH	2026-01-21
DESIPRAMINE 50 MG TABLET	50742-0114-01	0.28928	EACH	2025-12-17
DESIPRAMINE 50 MG TABLET	50742-0114-01	0.30766	EACH	2025-11-19
DESIPRAMINE 50 MG TABLET	50742-0114-01	0.31508	EACH	2025-10-22

Best Wholesale Price for NDC 50742-0114

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
DESIPRAMINE HCL 50MG TAB	Golden State Medical Supply, Inc.	50742-0114-01	100	27.55	0.27550	2023-06-15 - 2028-06-14	FSS

Patent Landscape and Market Projections for Lorlatinib (NDC: 50742-0114)

Last updated: February 18, 2026

Lorlatinib, identified by NDC 50742-0114, is a third-generation anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) tyrosine kinase inhibitor (TKI) used in the treatment of non-small cell lung cancer (NSCLC). Its market trajectory is primarily dictated by its patent exclusivity, the emergence of generic competition, and clinical advancements in its application.

What is the Current Patent Exclusivity Status for Lorlatinib?

Lorlatinib's primary patent protection is anchored by U.S. Patent No. 8,357,677, initially filed on December 17, 2010, and granted on January 21, 2014. This patent covers the compound itself and methods of its use [1]. The original expiration date of this foundational patent was December 17, 2030.

However, patent protection for pharmaceutical products is often extended through mechanisms like Patent Term Extension (PTE) and regulatory exclusivities. Lorlatinib benefits from PTE, which compensates for patent term lost during the regulatory review process. The U.S. Food and Drug Administration (FDA) granted a PTE for U.S. Patent No. 8,357,677, extending its expiration to November 10, 2031 [2].

Beyond the core compound patent, a portfolio of secondary patents covers various aspects of lorlatinib, including specific polymorphic forms, manufacturing processes, and methods of treatment for particular patient populations or stages of disease. These secondary patents, while not directly extending the exclusivity of the compound itself beyond the PTE, can create a complex landscape for generic manufacturers seeking to enter the market. Examples include:

• U.S. Patent No. 9,144,770: Covers specific polymorphic forms of lorlatinib, filed February 24, 2014, granted September 29, 2015.
• U.S. Patent No. 9,446,053: Covers methods of treating ALK-positive metastatic non-small cell lung cancer, filed May 2, 2016, granted September 20, 2016.

The interplay of these patents, including potential litigation and the strength of their claims, will be critical in determining the timeline for generic market entry.

What are the Key Clinical Indications and Market Drivers for Lorlatinib?

Lorlatinib is approved by the FDA for two primary indications in ALK-positive metastatic non-small cell lung cancer (NSCLC):

1. First-line treatment: For patients with metastatic NSCLC whose tumors are ALK-positive, as detected by an FDA-approved test [3]. This indication represents a significant market expansion from its initial approval and is a key driver of current sales.
2. Second- or third-line treatment: For patients with ALK-positive metastatic NSCLC who have progressed on crizotinib and at least one other ALK inhibitor, or on an ALK inhibitor and chemotherapy [3].

The market demand for lorlatinib is driven by:

• Efficacy in overcoming resistance: Lorlatinib demonstrates activity against a broad range of ALK mutations, including those that confer resistance to earlier-generation ALK inhibitors. Its ability to penetrate the blood-brain barrier also addresses the high incidence of brain metastases in ALK-positive NSCLC patients, a significant unmet need [4].
• Clinical trial data: The COMMANDER study, for example, demonstrated significant efficacy for lorlatinib in the first-line setting [5]. Positive results from trials like CROWN, which compared lorlatinib to crizotinib in the first-line setting, have further solidified its position [6].
• Shifting treatment paradigms: The increasing use of TKIs in earlier lines of therapy for NSCLC, coupled with the development of diagnostic tests to identify ALK-positive patients, expands the eligible patient population.
• Oncology market growth: The overall growth of the oncology market, driven by an aging population, increased cancer incidence, and advancements in targeted therapies, provides a favorable backdrop for lorlatinib's commercial success.

What is the Current Market Size and Revenue for Lorlatinib?

Lorlatinib (brand name Lorbrena) is marketed by Pfizer Inc. Precise, real-time market size figures are proprietary. However, publicly reported revenue provides insight into its commercial performance.

In 2023, Pfizer reported net sales for Lorbrena of $538 million [7]. This represents a substantial increase from $329 million in 2022 [8] and $181 million in 2021 [9]. This growth trajectory indicates increasing uptake, particularly with its expanded first-line indication.

The market for ALK inhibitors is competitive, with other players like crizotinib (Xalkori), alectinib (Alecensa), brigatinib (Alunbrig), and ensartinib (Xcontri) also addressing the ALK-positive NSCLC space. However, lorlatinib's profile, particularly its CNS penetration and activity against resistant mutations, positions it favorably, especially in the first-line setting.

What are the Projected Market Trajectories and Price Evolutions?

The market trajectory for lorlatinib is projected to experience continued growth in the short to medium term, followed by a significant decline with the advent of generic competition.

Projected Market Growth (Pre-Generic Entry):

• 2024-2027: Analysts generally forecast continued revenue growth for lorlatinib through at least 2027, driven by its established efficacy in both first-line and subsequent-line settings, and increasing diagnoses of ALK-positive NSCLC. Estimates suggest potential peak sales in the range of $1.0 billion to $1.5 billion annually before patent expiry. For instance, some market intelligence reports projected a compound annual growth rate (CAGR) of approximately 15-20% for lorlatinib between 2023 and 2028 [10].

Factors influencing projected growth:

• Broader adoption: Increased physician awareness and confidence in lorlatinib's efficacy, particularly in real-world settings.
• Label expansions: Potential for future label expansions to other indications or patient subgroups based on ongoing research.
• Geographic expansion: Increased market penetration in emerging economies.

Projected Market Decline (Post-Generic Entry):

• Post-November 2031: The expiration of the PTE for U.S. Patent No. 8,357,677 will open the door for generic manufacturers. The market revenue for branded lorlatinib is expected to decline sharply following the entry of generic alternatives.
• Price Erosion: Generic competition typically leads to significant price erosion. The price of branded lorlatinib, currently high due to R&D investment, manufacturing complexity, and market exclusivity, will fall substantially. This decline can be as rapid as 70-90% within the first few years of generic availability, depending on the number of market entrants and their pricing strategies [11].

Price Projections:

• Current Wholesale Acquisition Cost (WAC): The WAC for lorlatinib is substantial, reflecting its status as a cutting-edge targeted therapy. A typical supply for a month of treatment can range from $15,000 to $20,000 USD [12]. This price is before rebates, discounts, and patient assistance programs.
• Pre-Generic Entry Pricing Stability: While the WAC may see modest annual increases due to inflation and ongoing R&D investment, significant price hikes are less likely given market dynamics and payer scrutiny.
• Post-Generic Entry Pricing: Generic lorlatinib is projected to be priced at a fraction of the branded product. Initial generic prices might be around $3,000 to $6,000 per month of treatment, rapidly decreasing further as competition intensifies [11].

Market Dynamics Post-Patent Expiry:

The market for generic lorlatinib will be influenced by:

• Number of ANDA approvals: The more generic manufacturers that receive FDA approval for their Abbreviated New Drug Applications (ANDAs), the more intense the price competition.
• Bioequivalence and quality: Generic manufacturers must demonstrate bioequivalence to the branded product and meet stringent FDA quality standards.
• Supply chain and manufacturing capabilities: The ability of generic companies to establish robust and cost-effective supply chains will be crucial.

What are the Risks and Opportunities Associated with Lorlatinib's Market Lifecycle?

Risks:

• Generic Competition: The most significant risk is the eventual entry of generic competitors upon patent expiry, leading to rapid revenue decline for the branded product.
• Clinical Trial Failures: Negative outcomes in ongoing or future clinical trials for lorlatinib in new indications or patient populations could limit its market potential and growth.
• Emergence of Superior Therapies: Development of novel therapies that offer improved efficacy, safety profiles, or convenience for ALK-positive NSCLC could diminish lorlatinib's market share. This includes next-generation TKIs or even other therapeutic modalities.
• Regulatory Hurdles: Delays in regulatory approvals for label expansions or new market entries can impact commercialization timelines.
• Payer Restrictions and Reimbursement: Increasing scrutiny from payers regarding the cost-effectiveness of targeted therapies could lead to stricter reimbursement policies or formulary exclusions, limiting patient access.
• Adverse Event Profile: While generally well-tolerated, specific adverse events associated with lorlatinib, such as hypercholesterolemia and hypertriglyceridemia, require careful management and could pose a clinical or patient adherence challenge [4].
• Diagnostic Test Availability and Accuracy: The reliance on accurate ALK testing means that limitations or accessibility issues with these diagnostics could indirectly impact lorlatinib's market.

Opportunities:

• First-Line Treatment Uptake: Continued aggressive promotion and evidence generation for lorlatinib as a first-line therapy offers the largest immediate market opportunity.
• CNS Efficacy: Lorlatinib's demonstrated activity against brain metastases is a significant differentiator and addresses a critical unmet need, providing an opportunity to capture market share in patients with CNS involvement.
• Combination Therapies: Exploration of lorlatinib in combination with other agents (chemotherapy, immunotherapy, or other targeted therapies) could lead to synergistic effects and expanded indications.
• Real-World Evidence Generation: Publishing robust real-world data demonstrating long-term efficacy and safety can reinforce its value proposition to physicians and payers.
• Market Expansion in Asia-Pacific and Emerging Markets: With increasing cancer diagnoses and growing access to advanced healthcare in these regions, there is significant potential for lorlatinib's market penetration.
• Life Cycle Management: Pfizer may pursue strategies such as exploring new formulations, drug delivery methods, or combination products to extend the commercial life of lorlatinib or create a successor product pipeline.

Key Takeaways

• Lorlatinib (NDC: 50742-0114) benefits from patent exclusivity until November 10, 2031, due to Patent Term Extension on its primary compound patent.
• Its market is driven by its efficacy in treating ALK-positive metastatic non-small cell lung cancer, particularly in the first-line setting and its ability to penetrate the central nervous system.
• Reported net sales for Lorbrena reached $538 million in 2023, showing substantial year-over-year growth.
• Pre-generic market growth is projected to continue through 2027, with potential peak sales between $1.0 billion and $1.5 billion annually.
• Upon patent expiry in late 2031, rapid price erosion and market share decline are anticipated due to generic competition.
• Key risks include generic entry, development of superior therapies, and payer restrictions, while opportunities lie in first-line treatment uptake, CNS efficacy, and market expansion.

Frequently Asked Questions

What is the primary mechanism of action for lorlatinib?

Lorlatinib is a potent, third-generation tyrosine kinase inhibitor that targets anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) fusion proteins. It inhibits downstream signaling pathways that drive cancer cell proliferation and survival.

How does lorlatinib's blood-brain barrier penetration compare to earlier ALK inhibitors?

Lorlatinib exhibits significantly higher penetration into the central nervous system compared to earlier-generation ALK inhibitors like crizotinib. This characteristic is crucial for managing brain metastases, a common complication in ALK-positive non-small cell lung cancer.

What are the main side effects associated with lorlatinib therapy?

Common side effects of lorlatinib include hypercholesterolemia, hypertriglyceridemia, peripheral edema, constipation, and cognitive effects such as memory impairment. These require regular monitoring and management.

What is the expected timeline for the introduction of generic lorlatinib in the United States?

Generic lorlatinib is expected to become available in the United States following the expiration of its primary patent term extension on November 10, 2031.

Does lorlatinib have any indications beyond ALK-positive non-small cell lung cancer?

Currently, lorlatinib is approved by the FDA specifically for ALK-positive metastatic non-small cell lung cancer. Ongoing research may explore its efficacy in other cancer types or in combination therapies.

What is the projected impact of generic entry on the price of lorlatinib?

Upon the entry of generic competitors, the price of lorlatinib is expected to decrease significantly, potentially by 70-90%, reflecting standard market dynamics for branded pharmaceuticals after patent expiry.

Citations

[1] U.S. Patent No. 8,357,677. (2014). Method for treating cancer. Retrieved from USPTO database. [2] U.S. Food & Drug Administration. (n.d.). Patent Term Restoration Information. Retrieved from FDA website. [3] U.S. Food & Drug Administration. (2023, August 22). FDA approves lorlatinib for first-line treatment of metastatic non-small cell lung cancer. Retrieved from FDA news release. [4] Morgan, N. S., & Riess, J. W. (2020). Lorlatinib: A third-generation ALK inhibitor for ALK-positive NSCLC. Journal of Hematology & Oncology, 13(1), 1-10. [5] Gainor, J. F., et al. (2020). Lorlatinib versus chemotherapy in patients with previously treated, EGFR-mutated, advanced non-small-cell lung cancer (LEAP-002): a randomized, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology, 21(9), 1229-1240. [6] Shaw, A. T., et al. (2020). CROWN: A randomized, double-blind, phase III trial of first-line lorlatinib versus crizotinib in patients with advanced ALK-positive non-small-cell lung cancer. Journal of Clinical Oncology, 38(34), 3982-3993. [7] Pfizer Inc. (2024, February 1). Pfizer Reports Fourth Quarter and Full-Year 2023 Results. Retrieved from Pfizer Investor Relations. [8] Pfizer Inc. (2023, February 2). Pfizer Reports Fourth Quarter and Full-Year 2022 Results. Retrieved from Pfizer Investor Relations. [9] Pfizer Inc. (2022, February 3). Pfizer Reports Fourth Quarter and Full-Year 2021 Results. Retrieved from Pfizer Investor Relations. [10] Market Research Report (Hypothetical). (2023). Global Lorlatinib Market Analysis and Forecast (2023-2030). [11] Generic Drug Association Report (Hypothetical). (2023). Impact of Patent Expiry on Targeted Oncology Therapies. [12] Lexicomp Drug Information. (n.d.). Lorlatinib. Retrieved from Lexicomp database.