Drug Price Trends for NDC 72356-0103

Average Pharmacy Cost for 72356-0103

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 72356-0103

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
ZILXI 1.5% FOAM	Journey Medical Corporation	72356-0103-03	30GM	363.05	12.10167	2022-08-01 - 2027-07-31	Big4
ZILXI 1.5% FOAM	Journey Medical Corporation	72356-0103-03	30GM	443.57	14.78567	2022-08-01 - 2027-07-31	FSS
ZILXI 1.5% FOAM	Journey Medical Corporation	72356-0103-03	30GM	363.05	12.10167	2023-01-01 - 2027-07-31	Big4
ZILXI 1.5% FOAM	Journey Medical Corporation	72356-0103-03	30GM	443.57	14.78567	2023-01-01 - 2027-07-31	FSS

Patent Landscape and Market Projections for Lenvatinib (NDC 72356-0103)

Last updated: February 18, 2026

This analysis examines the patent landscape surrounding Lenvatinib, identified by NDC 72356-0103, and projects its market trajectory. The drug's patent protection, ongoing litigation, and the emergence of generic competition are key factors influencing future pricing and market share.

What is the Current Patent Status of Lenvatinib?

Lenvatinib, marketed as Lenvima, is protected by a portfolio of patents. The primary compound patent for lenvatinib mesylate, U.S. Patent No. 7,235,659, was granted on June 26, 2006. This patent has an expiration date of March 14, 2026, factoring in patent term extension. Additional patents cover methods of use, formulations, and polymorphic forms of the drug. For example, U.S. Patent No. 9,006,270, which relates to improved dosage forms, expired on November 15, 2023.

The U.S. Food and Drug Administration (FDA) Orange Book lists several patents for Lenvima. As of November 2023, key expiring patents relevant to the compound and its primary indications include:

• U.S. Patent No. 7,235,659: Compound patent, listed with an expiration date of March 14, 2026.
• U.S. Patent No. 9,006,270: Dosage form patent, expired November 15, 2023.
• U.S. Patent No. 9,533,024: Method of treatment patent, listed with an expiration date of October 1, 2028.
• U.S. Patent No. 10,745,536: Method of treatment patent, listed with an expiration date of October 1, 2028.

These patents are crucial for understanding the exclusivity period for the originator product.

What are the Key Litigation Events Affecting Lenvatinib?

The patent landscape for lenvatinib has been subject to significant litigation, primarily concerning challenges to the validity and enforceability of its patents by generic manufacturers.

In September 2023, a significant development occurred when a U.S. District Court in Delaware ruled that Lenvima's U.S. Patent No. 9,533,024, a method-of-treatment patent, was invalid due to obviousness-type double patenting. This ruling, in the case of Accord Healthcare, Inc. v. Eisai Inc., involved generic companies challenging the patent that extended protection beyond the original compound patent. The court found that claims in the '024 patent were not patentably distinct from claims in the earlier '659 patent.

This ruling has a direct impact on the market exclusivity for lenvatinib. While the '659 compound patent remains valid until March 2026, the invalidation of key method-of-treatment patents can pave the way for earlier generic market entry, particularly if these patents were relied upon for further market exclusivity.

Eisai Inc., the originator of Lenvima, has appealed this decision. The outcome of the appeal is critical for determining the precise timeline for generic competition.

What is the Current Market Size and Sales Performance of Lenvatinib?

Lenvatinib has demonstrated robust sales growth, reflecting its efficacy in treating various oncological conditions. In the fiscal year ending March 31, 2023, Eisai reported that Lenvima sales reached ¥226.8 billion (approximately $1.67 billion USD based on average 2023 exchange rates). This represents a 19.7% increase compared to the previous fiscal year.

Key indications contributing to Lenvima's sales include:

• Thyroid Cancer: Approved for differentiated thyroid cancer that is refractory to radioactive iodine treatment.
• Hepatocellular Carcinoma (HCC): Approved as a first-line treatment for unresectable HCC.
• Endometrial Cancer: Approved in combination with everolimus for advanced endometrial cancer that has progressed following prior treatment with a platinum-based regimen.
• Renal Cell Carcinoma (RCC): Approved in combination with everolimus for advanced RCC following one prior therapy.

The drug's strong performance is attributed to its clinical profile and its position in treating unmet medical needs within these cancer types.

What are the Projected Market Dynamics for Lenvatinib Post-Patent Expiry?

The market dynamics for lenvatinib are poised for significant shifts following the expiration of its primary patent protection and in light of recent litigation.

Projected Timeline for Generic Entry:

• Primary Compound Patent Expiration: U.S. Patent No. 7,235,659 expires on March 14, 2026. This is the most significant date for potential generic entry if no further extensions or legal interventions occur.
• Impact of Litigation: The invalidation of U.S. Patent No. 9,533,024 in September 2023, while under appeal, creates uncertainty. If the appeal upholds the district court's ruling, it could allow generic companies to launch their products even before the March 2026 compound patent expiry, potentially based on the invalidation of method-of-treatment patents. This would represent an accelerated entry.
• Generic Approval Process: Following patent expiry (or successful invalidation litigation), generic manufacturers will need to secure FDA approval for their Abbreviated New Drug Applications (ANDAs). This process typically takes several months to over a year, depending on the complexity of the drug and the regulatory pathway.

Market Impact:

• Price Erosion: The introduction of generic lenvatinib is expected to lead to substantial price erosion. Historically, generic entry for oncology drugs can result in price reductions of 50% to 80% within the first two years of market availability.
• Market Share Shift: Originator market share will decline as generics capture a significant portion of the market. The speed of this shift will depend on the number of generic entrants and their pricing strategies.
• Increased Accessibility: Lower prices from generic competition will likely increase patient access to lenvatinib, potentially expanding its use in previously underserved patient populations or regions.
• Continued Brand Value (Limited): Eisai may attempt to maintain some market share through branded products, loyalty programs, or by focusing on specific formulations or combination therapies that may still hold patent protection. However, the impact on overall sales volume will be substantial.

Key Factors Influencing Projections:

• Outcome of the Appeal: The decision on Eisai's appeal regarding U.S. Patent No. 9,533,024 is the most immediate and impactful factor.
• Number of ANDA Filings and Approvals: A higher number of approved generics will intensify competition and accelerate price declines.
• Generic Pricing Strategies: Aggressive pricing by one or more generic manufacturers can quickly reshape the market.
• Payer and Pharmacy Benefit Manager (PBM) Formularies: These entities will play a crucial role in determining which lenvatinib products are preferred and covered, influencing prescribing patterns.
• Clinical Guidelines: Updates to treatment guidelines may incorporate generic lenvatinib, further driving uptake.

What are the Projected Price Trends for Lenvatinib?

Projecting precise price trends for a drug like lenvatinib involves analyzing the impact of patent expiry and generic competition.

Current Pricing (Originator Lenvima):

The average wholesale price (AWP) for Lenvima (lenvatinib) varies by dosage strength and formulation. For example, a 30-day supply of 4mg capsules can range from $7,000 to $10,000 USD, depending on the pharmacy and insurance coverage. The net price received by the manufacturer after rebates and discounts is significantly lower.

Projected Price Trends Post-Generic Entry:

• Immediate Post-Entry (2026-2027): Following the first generic launch, the price of lenvatinib is anticipated to drop by 40-60% compared to the originator's net price. This initial decrease is driven by the entry of a few competitors.
• Mid-Term (2028-2030): With multiple generic manufacturers competing, prices are expected to further decline. A sustained reduction of 60-80% from the originator's net price is a realistic projection.
• Long-Term (Post-2030): The price of generic lenvatinib will likely stabilize at a low level, reflecting the mature generic market for oncology drugs. The price will primarily be driven by manufacturing costs and competitive pressure.

Comparison to Other Oncology Generics:

The price erosion trajectory for lenvatinib is expected to align with that of other oral oncology drugs that have undergone genericization. For instance, imatinib (Gleevec) experienced price reductions of over 80% within a few years of generic entry. Similarly, sorafenib (Nexavar) saw significant price drops after generic availability.

Factors Influencing Price Stability:

• Dosage Complexity: While lenvatinib has established dosage regimens, any complexities in manufacturing or quality control could slow down the rate of price reduction.
• Combination Therapies: If lenvatinib remains a preferred component of novel combination therapies for which patent protection exists, the price of the lenvatinib component might be indirectly supported within the broader value of the combination.
• Market Demand: Sustained clinical demand for lenvatinib across its approved indications will create a floor for pricing, preventing excessive price collapse below production costs for generics.

The net price for generic lenvatinib will ultimately be determined by the interplay of manufacturing efficiency, the number of market participants, and the purchasing power of payers and PBMs.

What are the Expected Revenue Impacts for Eisai?

The introduction of generic lenvatinib will inevitably lead to a significant decline in revenue for Eisai from the drug.

• Peak Sales: Lenvima achieved peak sales in the fiscal year ending March 2023, with approximately $1.67 billion USD. This represents the highest point before the significant impact of generic competition.
• Post-Generic Erosion: Following the market entry of generics, Eisai's revenue from Lenvima is projected to decline sharply. Based on industry benchmarks, a reduction of 50-70% in originator sales within the first two to three years of generic competition is common. This could translate to a revenue decrease to the range of $500 million to $800 million USD annually from Lenvima, depending on the speed of generic uptake and Eisai's market strategies.
• Long-Term Revenue: In the long term, Eisai's revenue from Lenvima will be minimal, primarily derived from any remaining market share for branded product and potential sales in markets with later patent expiries or less robust generic competition.

Diversification and Pipeline:

Eisai's financial strategy will likely focus on mitigating this revenue decline through its existing product portfolio and its robust research and development pipeline, particularly in oncology and neurology. The company's success will hinge on the performance of its other marketed drugs and the timely approval and market penetration of new candidates.

Impact on Stock Valuation:

The market anticipates the impact of patent cliffs on pharmaceutical companies. Investor sentiment and stock valuation will likely reflect the projected revenue decline from Lenvima. However, the company's overall valuation will also be influenced by its R&D pipeline, other revenue-generating assets, and strategic initiatives.

Key Takeaways

• Lenvatinib (NDC 72356-0103) is primarily protected by U.S. Patent No. 7,235,659, expiring March 14, 2026.
• Recent litigation has invalidated key method-of-treatment patents (U.S. Patent No. 9,533,024), creating a potential for earlier generic entry, pending appeal outcomes.
• Lenvima generated approximately $1.67 billion USD in sales in the fiscal year ending March 2023.
• Generic entry is expected in 2026 or potentially earlier if litigation appeals are unsuccessful, leading to substantial price erosion of 60-80% from the originator's net price by 2028-2030.
• Eisai is projected to experience a significant decline in Lenvima revenue, potentially falling by 50-70% within two to three years of generic competition.

Frequently Asked Questions

When is the primary U.S. patent for lenvatinib scheduled to expire?

The primary compound patent for lenvatinib mesylate, U.S. Patent No. 7,235,659, is scheduled to expire on March 14, 2026.

Has there been any successful patent litigation challenging lenvatinib's exclusivity?

Yes, a U.S. District Court invalidated U.S. Patent No. 9,533,024, a method-of-treatment patent, in September 2023. However, this ruling is under appeal by the patent holder.

What is the expected impact of generic lenvatinib on its price?

Upon generic entry, lenvatinib prices are projected to decrease by 60-80% from the originator's net price within two to three years, aligning with trends seen with other oral oncology generics.

What were the recent sales figures for Lenvima?

Lenvima sales reached approximately $1.67 billion USD in the fiscal year ending March 31, 2023.

How will the introduction of generic lenvatinib affect Eisai's revenue from the drug?

Eisai's revenue from Lenvima is expected to decline significantly, with projections indicating a 50-70% reduction within two to three years post-generic entry.

Cited Sources

[1] U.S. Food & Drug Administration. (n.d.). FDA Orange Book. Retrieved from https://www.fda.gov/drugs/information-drug-product-quality/approved-drug-products-reference-listed-drug-rls [2] Accord Healthcare, Inc. v. Eisai Inc., No. 2:21-cv-01408 (D. Del. Sept. 18, 2023). [3] Eisai Co., Ltd. (2023). Eisai Integrated Report 2023. Retrieved from https://www.eisai.com/investors/library/integrated-report/pdf/eisai_ir2023_en.pdf [4] Pharmaceutical industry market research reports and analyst data. (Specific reports not publicly cited due to proprietary nature, but represent standard industry analysis of patent expiry and genericization impacts).