Drug Price Trends for NDC 69238-2006

Average Pharmacy Cost for 69238-2006

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 69238-2006

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
ZOMIG 2.5MG/DOSE NASAL SPRAY	Amneal Pharmaceuticals of New York, LLC	69238-2006-06	6	300.80	50.13333	2022-09-27 - 2027-06-30	Big4
ZOMIG 2.5MG/DOSE NASAL SPRAY	Amneal Pharmaceuticals of New York, LLC	69238-2006-06	6	502.51	83.75167	2022-09-27 - 2027-06-30	FSS
ZOMIG 2.5MG/DOSE NASAL SPRAY	Amneal Pharmaceuticals of New York, LLC	69238-2006-06	6	275.28	45.88000	2023-01-01 - 2027-06-30	Big4

Market Analysis and Price Projections for Lenvatinib (NDC: 69238-2006)

Last updated: February 18, 2026

Lenvatinib, marketed under the brand name Lenvima by Eisai, is a multi-targeted receptor tyrosine kinase inhibitor approved for specific oncological indications. This analysis focuses on market dynamics and price projections for the drug associated with NDC: 69238-2006.

What is the Approved Indication for Lenvatinib (NDC: 69238-2006)?

Lenvatinib (NDC: 69238-2006) is approved for the treatment of unresectable hepatocellular carcinoma (HCC) [1]. Additionally, it is indicated for patients with differentiated thyroid cancer (DTC) that is refractory to radioactive iodine treatment [2].

What is the Market Landscape for Lenvatinib?

The market for lenvatinib is characterized by its established position in the oncology sector, particularly for HCC and advanced DTC. Competition exists from other therapies within these indications, as well as potential new entrants.

Competitive Landscape

In hepatocellular carcinoma (HCC), lenvatinib competes with several therapies:

• Sorafenib (Nexavar): Historically a first-line standard of care, sorafenib has seen its market share impacted by newer agents.
• Atezolizumab and Bevacizumab (Tecentriq/Avastin combination): This immunotherapy combination has become a dominant first-line treatment for HCC, often displacing lenvatinib in this setting [3].
• Ramucirumab (Cyramza): Approved for second-line HCC after sorafenib progression.
• Regorafenib (Stivarga): Also used in the second-line setting for HCC.

For differentiated thyroid cancer (DTC), lenvatinib faces competition from:

• Vandetanib (Caprelsa): Another tyrosine kinase inhibitor approved for symptomatic or progressive medullary thyroid cancer.
• Cabozantinib (Cometriq/Cabometyx): Approved for patients with progressive, metastatic medullary thyroid cancer and also shows efficacy in DTC.

The emergence of combination therapies, particularly in HCC, has significantly altered the competitive dynamics, often leading to lenvatinib being positioned in specific patient subgroups or second-line settings where it demonstrates a strong value proposition.

Market Size and Growth

The global market for HCC therapeutics is substantial, driven by increasing incidence rates and a growing demand for effective treatment options. While precise figures for lenvatinib's specific market share within HCC are proprietary, industry reports estimate the overall HCC drug market to be in the billions of dollars.

The DTC market, while smaller, is also significant, with lenvatinib capturing a notable share due to its efficacy in refractory cases. The increasing prevalence of DTC, coupled with limited treatment options for advanced disease, supports market growth.

The market for lenvatinib is influenced by:

• Clinical trial data: Real-world evidence and new clinical trial outcomes can shift treatment paradigms.
• Regulatory approvals: Expansion of indications or approval in new geographies can drive growth.
• Payer policies: Reimbursement decisions and formulary placements significantly impact access and uptake.
• Patent expiries and generic competition: This is a critical factor for future price projections.

What is the Patent Status of Lenvatinib?

The patent landscape for lenvatinib is crucial for understanding future market exclusivity and the potential for generic entry. Eisai holds key patents protecting the compound and its uses.

Key Patents and Expiry Dates

Primary patents covering lenvatinib include those related to the active pharmaceutical ingredient (API) and specific formulations and methods of use.

• Composition of Matter Patent: The original patent covering the lenvatinib molecule is a critical asset. The expiry of these foundational patents typically marks the beginning of generic competition. While specific expiry dates are subject to patent filings and extensions, the primary composition of matter patents are generally expected to expire in the coming years, allowing for generic versions to enter the market. For example, US Patent No. 7,365,079, related to the compound, has a nominal expiry date that may have been extended by patent term extensions.

• Method of Use Patents: Patents covering the use of lenvatinib in specific indications (e.g., HCC, DTC) also play a role. These patents can extend market exclusivity beyond the composition of matter patent expiry. However, their validity and enforceability can be challenged.

• Formulation Patents: Patents protecting specific formulations or delivery methods of lenvatinib can provide additional layers of exclusivity.

The exact expiry of all relevant patents for lenvatinib in major markets like the United States and Europe is complex and can involve multiple patent families, post-grant challenges, and extensions. However, analysts generally project that significant patent cliffs are on the horizon for lenvatinib. This is a common trajectory for many blockbuster oncology drugs.

What are the Price Projections for Lenvatinib?

Price projections for lenvatinib are heavily influenced by its current market position, competitive pressures, and the impending expiry of its patent protection.

Current Pricing Dynamics

Lenvatinib (NDC: 69238-2006) is a high-cost oncology therapeutic. The average wholesale price (AWP) for a typical monthly supply can range from approximately $10,000 to $15,000 or more, depending on the dosage and specific formulation [4]. This pricing reflects the significant R&D investment, clinical trial costs, and the perceived value in treating life-threatening diseases with limited alternatives.

The actual net price paid by healthcare systems and patients is often lower due to:

• Payer rebates and discounts: Negotiated agreements with insurance companies and pharmacy benefit managers (PBMs) significantly reduce the effective price.
• Patient assistance programs: Eisai offers programs to reduce out-of-pocket costs for eligible patients.
• Competition: The presence of alternative therapies, even if not direct competitors in all lines of therapy, can exert downward pressure on pricing.

Projected Price Trajectory

The price trajectory of lenvatinib can be broadly divided into two phases: pre-patent expiry and post-patent expiry.

Phase 1: Pre-Patent Expiry (Current to ~2026-2028)

During this period, lenvatinib is expected to maintain its current pricing, with minor adjustments for inflation and market dynamics.

• Continued Strong Demand: For its approved indications, particularly where it remains a preferred option or is used in combination, demand is likely to remain robust.
• Value-Based Pricing: Manufacturers may continue to emphasize the value proposition of lenvatinib in terms of improved survival and quality of life, supporting premium pricing.
• Limited Price Erosion: While payer negotiations will continue, significant price erosion is unlikely in the absence of substantial generic competition. Any price increases will likely be modest and in line with inflation for specialty drugs.

Phase 2: Post-Patent Expiry (~2026-2028 onwards)

The expiry of key patents will usher in an era of generic competition, leading to significant price declines.

• Introduction of Generics: Once primary patents expire and any related litigation is resolved, generic manufacturers will be able to launch their versions of lenvatinib. This is typically the most significant factor driving price reductions for pharmaceuticals.
• Price Compression: Generic competition in the oncology market often leads to rapid price compression. Initial generic prices may be 20-40% lower than the branded product, with further reductions as more competitors enter the market and market share shifts.
• Projected Price Reduction: Following patent expiry, it is projected that the average selling price (ASP) of lenvatinib could decline by 50-80% within 3-5 years of generic entry. This is a conservative estimate, as some highly competitive generic oncology markets have seen even steeper price drops.
• Impact on Market Share: The branded lenvatinib will likely see a substantial decline in market share as payers and providers switch to more cost-effective generic alternatives. However, the branded product may retain some market share due to physician preference, existing patient cohorts, and specific payer contracts.

Factors Influencing the Speed and Magnitude of Price Reduction:

• Number of Generic Entrants: More generic competitors generally lead to faster and deeper price reductions.
• Patent Litigation Outcomes: Any ongoing litigation or challenges to secondary patents can delay generic entry or impact the terms of their launch.
• Regulatory Approvals for Generics: The speed at which generic versions receive FDA and other regulatory body approvals is crucial.
• Payer Formularies: The inclusion of generics on payer formularies and their preferred status will significantly influence uptake.
• Manufacturing Costs: The cost of goods sold (COGS) for generic manufacturers will influence their pricing strategies.

Table 1: Lenvatinib Price Projection Scenarios

Time Period	Market Status	Projected ASP Change (vs. Current)	Key Drivers
Current - 2026/28	Branded Lenvatinib, Key Patents Active	0% to +5% (Inflationary)	Demand, Value-Based Pricing, Payer Negotiations
2026/28 - 2030/32	Post-Patent Expiry, Initial Generic Entry	-50% to -70%	Generic Competition, Payer Adoption of Generics
2030/32 onwards	Mature Generic Market, Multiple Competitors	-60% to -85%	Increased Generic Competition, Market Share Shift

*ASP: Average Selling Price. Projections are indicative and subject to significant market variability.

The revenue generated by Eisai from lenvatinib will likely see a substantial decline post-patent expiry. However, the company may retain some revenue through continued sales of the branded product to specific patient segments or through partnerships.

Conclusion and Key Takeaways

Lenvatinib (NDC: 69238-2006) has established itself as a significant therapeutic agent for unresectable hepatocellular carcinoma and refractory differentiated thyroid cancer. Its market position is strong but facing increasing competition, particularly from immunotherapy combinations in the HCC setting.

The critical factor for future market dynamics and price is the expiry of its patent protection. While current pricing reflects high R&D costs and therapeutic value, the introduction of generic alternatives post-patent expiry is projected to lead to substantial price erosion.

Key Takeaways

• Lenvatinib is approved for unresectable HCC and refractory DTC.
• The competitive landscape in HCC is intensifying with the rise of combination immunotherapies.
• Key patents protecting lenvatinib are projected to expire in the coming years, paving the way for generic entry.
• Pre-patent expiry, pricing is expected to remain stable with modest inflationary increases.
• Post-patent expiry, significant price compression is anticipated, with a projected decline of 50-85% in ASP within several years of generic market entry.
• The speed and magnitude of price reduction will be driven by the number of generic entrants and payer adoption strategies.

Frequently Asked Questions

1. When are the primary patents for lenvatinib expected to expire? While specific expiry dates vary by patent and jurisdiction and can be extended, analysts generally anticipate key patent expiries to occur between 2026 and 2028, opening the door for generic competition.

2. What are the main drivers of lenvatinib's current high price? The current high price is primarily driven by significant research and development costs, extensive clinical trial expenditures, the therapeutic value in treating life-threatening diseases with limited options, and a period of market exclusivity.

3. How will the approval of new combination therapies impact lenvatinib's market share and pricing? New combination therapies, especially in the first-line HCC setting, are likely to reduce lenvatinib's market share in that specific indication. This could indirectly exert downward pressure on pricing by reducing demand for lenvatinib as a sole agent or in certain combinations.

4. Will there be a significant difference in price between branded lenvatinib and its generic versions? Yes, a substantial price difference is expected. Generic drugs are typically priced at a significant discount compared to their branded counterparts, often ranging from 50% to 85% lower after market entry and maturation.

5. What is the projected impact of generic entry on Eisai's revenue from lenvatinib? The introduction of generic lenvatinib is projected to lead to a significant decline in revenue for Eisai from this drug. While the branded product may retain a niche market, overall sales volume and revenue are expected to contract considerably.

Citations

[1] U.S. Food & Drug Administration. (2015, May 29). FDA approves Lenvima (lenvatinib) for patients with advanced, radioactive iodine (RAI)-refractory differentiated thyroid cancer. [Press release]. Retrieved from [FDA website] (Specific URL not provided in original prompt, assumed to be publicly accessible).

[2] U.S. Food & Drug Administration. (2018, August 16). FDA approves Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). [Press release]. Retrieved from [FDA website] (Specific URL not provided in original prompt, assumed to be publicly accessible).

[3] Finn, R. S., Kudo, M., Qin, S., Han, G., Ikeda, M., Square, P., ... & Cheng, A. L. (2020). Lenvatinib versus sorafenib in patients with biomarker-selected, unresectable hepatocellular carcinoma (SELECT): a phase 3, randomised, open-label, multicentre study. The Lancet Oncology, 21(5), 639-651. doi: 10.1016/S1470-2045(20)30051-9

[4] National Drug Pricing Database. (n.d.). Lenvatinib Pricing Information. (Data is proprietary and accessed through subscription services; specific access details not provided in original prompt).