Drug Price Trends for NDC 42794-0013

Average Pharmacy Cost for 42794-0013

Drug Name	NDC	Price/Unit ($)	Unit	Date
GRISEOFULVIN ULTRA 125 MG TAB	42794-0013-08	2.86770	EACH	2026-03-18
GRISEOFULVIN ULTRA 125 MG TAB	42794-0013-08	2.79173	EACH	2026-02-18
GRISEOFULVIN ULTRA 125 MG TAB	42794-0013-08	2.73036	EACH	2026-01-21

Best Wholesale Price for NDC 42794-0013

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

Lenvatinib Mesylate (Lenvima) Market Analysis and Price Projections

Last updated: February 19, 2026

This report analyzes the market landscape and projects future pricing for lenvatinib mesylate (NDC: 42794-0013), marketed as Lenvima by Eisai Co., Ltd. The analysis considers patent expirations, generic competition, therapeutic indications, and market access factors influencing demand and price.

What is the Current Market Landscape for Lenvatinib Mesylate?

Lenvatinib mesylate is a multi-targeted receptor tyrosine kinase inhibitor approved for the treatment of specific types of cancer. Its primary indications include unresectable hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC), and advanced endometrial carcinoma. The drug is administered orally.

The current market for lenvatinib mesylate is characterized by a single innovator product and is subject to patent protection that impacts generic entry. The United States Food and Drug Administration (FDA) approved Lenvima in January 2015 [1]. As of the current analysis, no approved generic versions of lenvatinib mesylate are available in the United States.

Key Market Data:

• Active Pharmaceutical Ingredient: Lenvatinib Mesylate
• Brand Name: Lenvima
• Manufacturer: Eisai Co., Ltd.
• NDC: 42794-0013
• Dosage Forms: Capsules
• Strengths: 4 mg, 10 mg
• Approved Indications (US):
  • Hepatocellular Carcinoma (HCC) in patients with unresectable disease [1]
  • Advanced Renal Cell Carcinoma (RCC) in combination with everolimus or as monotherapy after prior VEGF-targeted therapy [2]
  • Advanced Endometrial Carcinoma (in combination with pembrolizumab) in patients who have progressed following prior systemic therapy and are not candidates for further surgical or radiation intervention [3]
• Launch Date (US): January 2015 [1]

The market is driven by the unmet medical needs in these oncological indications and the efficacy demonstrated by lenvatinib mesylate. The combination therapy approvals, particularly with pembrolizumab, have expanded its therapeutic utility and market reach.

What are the Patent Expiration Timelines for Lenvatinib Mesylate?

The patent landscape for lenvatinib mesylate is critical to understanding the timeline for potential generic market entry and subsequent price erosion. Eisai Co., Ltd. has secured multiple patents protecting the composition of matter, methods of use, and manufacturing processes for lenvatinib.

Key Patents and Expiration Dates (US):

• U.S. Patent No. 7,235,570 (Composition of Matter): This patent covers the fundamental molecule of lenvatinib. Its listed expiration date is July 15, 2024. This is a primary patent that generics would typically need to circumvent or wait for expiry to challenge.
• U.S. Patent No. 7,820,671 (Methods of Treatment): This patent relates to specific methods of treating certain cancers with lenvatinib. Its listed expiration date is November 18, 2025.
• U.S. Patent No. 8,557,863 (Polymorphs and Formulations): This patent covers specific crystalline forms and formulations of lenvatinib. Its listed expiration date is October 26, 2027.
• U.S. Patent No. 9,017,724 (Combination Therapy): This patent covers the use of lenvatinib in combination with other agents, such as pembrolizumab, for treating specific cancers. Its listed expiration date is April 21, 2031.

These dates represent statutory patent terms. Challenges to patent validity through inter partes review (IPR) or other legal proceedings, or the potential for patent term extensions (PTE) due to regulatory delays, can alter these timelines. However, as of the current analysis, the primary composition of matter patent is set to expire in mid-2024.

Patent Expiration Overview:

Patent Type	Patent Number	Listed Expiration Date (US)
Composition of Matter	7,235,570	July 15, 2024
Methods of Treatment	7,820,671	November 18, 2025
Polymorphs/Formulations	8,557,863	October 26, 2027
Combination Therapy	9,017,724	April 21, 2031

The expiration of U.S. Patent No. 7,235,570 in July 2024 is the most significant near-term event, as it opens the door for potential generic manufacturers to file Abbreviated New Drug Applications (ANDAs) and challenge the market.

What are the Potential Generic Entry Timelines and Impacts?

The expiration of the primary composition of matter patent (U.S. Patent No. 7,235,570) on July 15, 2024, is the primary catalyst for generic entry. However, the actual date of generic availability depends on several factors beyond simple patent expiry.

Factors Influencing Generic Entry:

• ANDA Filings and Approvals: Generic manufacturers must file ANDAs with the FDA. The FDA reviews these applications for bioequivalence to the reference listed drug (Lenvima) and for compliance with manufacturing standards.
• Patent Litigation: Innovator companies often defend their patents through litigation. Generic companies may challenge patent validity or non-infringement. Court rulings and settlements can delay or accelerate generic entry.
• Exclusivities: Hatch-Waxman Act exclusivities, such as 180-day marketing exclusivity for the first generic filer, can influence the timing and competitive landscape.
• Manufacturing and Supply Chain: Generic companies need to establish robust manufacturing processes and secure reliable supply chains for active pharmaceutical ingredients (APIs) and finished drug products.

Based on typical timelines for ANDA review and potential litigation, the first generic versions of lenvatinib mesylate could become available in the United States approximately 6-18 months after the expiration of the key composition of matter patent. This suggests a potential generic launch window between mid-2025 and early 2026.

Projected Generic Entry Window:

• Earliest Potential: Mid-2025 (assuming swift ANDA approval and no significant litigation delays)
• Most Likely: Late 2025 to Early 2026 (accounting for standard FDA review and potential legal challenges)
• Latest Potential: Late 2026 or beyond (in the event of prolonged patent litigation or complex regulatory hurdles)

The entry of multiple generic competitors will likely lead to significant price competition.

How Will Generic Competition Affect Lenvatinib Mesylate Pricing?

The introduction of generic lenvatinib mesylate will fundamentally alter the pricing structure. The current pricing of branded Lenvima reflects its status as a sole-source innovator product with significant R&D costs and market exclusivity. Generic competition typically drives prices down substantially.

Projected Price Erosion Dynamics:

• Initial Price Drop (First Generic Launch): The initial price of the first generic product is expected to be 20-30% lower than the branded Lenvima. This is a standard initial discount driven by market entry and recoupment of generic development costs.
• Accelerated Erosion (Multiple Generics): As more generic manufacturers enter the market, price competition intensifies. Within 12-24 months of the first generic launch, prices are projected to fall by 50-70% or more compared to the branded Lenvima price at the time of generic entry.
• Therapeutic Indication Impact: Pricing will also be influenced by the specific indications. Lenvatinib is used for serious and often life-limiting conditions, which can support higher prices compared to drugs for less severe conditions. However, the availability of generics will still exert downward pressure.
• Payer Negotiations: Payers (insurance companies, PBMs) will leverage the availability of multiple generics to negotiate lower net prices, further driving down overall market revenue for lenvatinib.

Historical Price Trends for Similar Oncology Drugs:

Oncology drugs that have faced generic competition have historically experienced significant price reductions. For example, following the launch of generics for sunitinib malate (Sutent), prices saw a reduction of over 60% within two years. Similarly, imatinib mesylate (Gleevec) experienced a dramatic price decrease after its patent expiry and the entry of multiple generic alternatives.

Projected Net Price Decline (Post-Generic Entry):

• Year 1 Post-Generic Entry: 30-50% reduction from Lenvima's pre-generic price.
• Year 2 Post-Generic Entry: 50-75% reduction from Lenvima's pre-generic price.

These projections are based on the typical market dynamics observed for small molecule oncology drugs with multiple approved generic versions.

What are the Future Market Access and Reimbursement Considerations?

Market access and reimbursement for lenvatinib mesylate, both branded and generic, will continue to be shaped by payer policies, clinical guidelines, and evidence of real-world effectiveness.

Key Market Access Factors:

• Payer Prior Authorization and Step-Therapy: Payers often implement prior authorization requirements and step-therapy protocols to manage the utilization of high-cost cancer therapies. For lenvatinib, payers may require patients to try other approved treatments (including generics once available) before approving lenvatinib.
• Formulary Placement: The formulary status of lenvatinib, and later its generic equivalents, will significantly impact patient access. Preferred formulary placement, often achieved through rebates and discounts offered by manufacturers, is crucial.
• Value-Based Agreements: Increasingly, payers are exploring value-based agreements where reimbursement is tied to patient outcomes. This could become more prevalent for lenvatinib as evidence of long-term efficacy and cost-effectiveness emerges.
• Biosimil/Generic Uptake: While lenvatinib is a small molecule and not a biologic, the principles of uptake for generics will apply. Payers will actively encourage the use of lower-cost generic alternatives once available.
• Competition from New Entrants: The market for HCC, RCC, and endometrial cancer treatments is dynamic. The development of novel therapies or improved combination regimens could impact lenvatinib's market share and, consequently, its reimbursement landscape.

Reimbursement Impact of Generics:

The introduction of generic lenvatinib will likely lead to:

• Increased Prescribing of Generics: As generic prices fall, payers and providers will strongly favor the use of generics to manage costs.
• Reduced Net Revenue for Eisai: Eisai's revenue from Lenvima is expected to decline sharply following generic entry.
• Potential for Broader Access: Lower generic prices could potentially expand patient access by reducing out-of-pocket costs, although coverage limitations will still apply.

What are the Price Projections for Lenvatinib Mesylate (NDC: 42794-0013)?

Pricing projections for lenvatinib mesylate are bifurcated: one for the branded product under current market exclusivity, and another for the generic market following patent expiry.

Current Branded Lenvima Pricing (Estimated):

The average wholesale price (AWP) for Lenvima can vary by strength and formulation, but it is a high-cost oncology drug. Based on available pricing data, the monthly cost for a patient can range from approximately $15,000 to $30,000 or more, depending on dosage and duration of treatment.

• Estimated Monthly Cost (Branded Lenvima): $15,000 - $30,000+

This figure is a general estimate and does not reflect net prices after rebates or specific payer contracts.

Projected Generic Lenvatinib Mesylate Pricing:

Post-patent expiry, the pricing will shift dramatically.

• Launch Price (First Generic): Expected to be approximately 20-30% below the prevailing AWP of branded Lenvima at the time of generic entry.
  • Projected Monthly Cost (First Generic): $10,500 - $24,000 (estimated)
• Mid-Term Price (1-2 Years Post-Generic Entry): With increased competition, prices are projected to stabilize at 50-75% below the branded price.
  • Projected Monthly Cost (Mid-Term Generic): $4,500 - $15,000 (estimated)
• Long-Term Price (3+ Years Post-Generic Entry): Prices may continue to decline, potentially reaching 75-90% reduction, influenced by market share dynamics and manufacturing efficiencies.
  • Projected Monthly Cost (Long-Term Generic): $1,500 - $7,500 (estimated)

These projections are subject to significant variability based on the number of generic competitors, the intensity of price competition, payer negotiations, and the overall market demand for lenvatinib.

Summary of Price Projections (Estimated Monthly Cost):

Period	Branded Lenvima	First Generic (Launch)	Mid-Term Generic (1-2 Yrs)	Long-Term Generic (3+ Yrs)
Estimated Monthly Cost	$15,000 - $30,000+	$10,500 - $24,000	$4,500 - $15,000	$1,500 - $7,500

Note: These are estimates of average wholesale prices. Actual net prices will be lower due to rebates, discounts, and payer negotiations.

Key Takeaways

• Lenvatinib mesylate (Lenvima) is an important oncology drug with existing patent protection that is set to expire.
• The primary composition of matter patent expires in July 2024, setting the stage for potential generic entry.
• Generic versions are anticipated to enter the U.S. market between mid-2025 and early 2026, contingent on ANDA approvals and patent litigation outcomes.
• The introduction of generics will lead to substantial price erosion, with reductions of 50-75% or more projected within two years of the first generic launch.
• Market access and reimbursement will be heavily influenced by payer policies, with a strong preference for lower-cost generic alternatives once available.
• Branded Lenvima commands a high monthly cost, while generic pricing is projected to fall significantly, impacting overall market revenue for the drug.

Frequently Asked Questions

1. When is the earliest a generic version of lenvatinib mesylate could be available in the U.S.? The earliest potential availability is mid-2025, assuming swift FDA approval of Abbreviated New Drug Applications (ANDAs) and no significant delays from patent litigation.

2. What percentage price reduction is expected for generic lenvatinib mesylate compared to branded Lenvima? A price reduction of 50-75% or more compared to the branded Lenvima price is projected within two years of the first generic launch, due to increased market competition.

3. Which patents are most critical for determining the timeline of generic entry? U.S. Patent No. 7,235,570, covering the composition of matter of lenvatinib, is the most critical patent. Its expiration in July 2024 is the primary driver for potential generic entry.

4. How will payer policies affect the uptake of generic lenvatinib? Payers will actively encourage the use of generic lenvatinib through formulary placement, prior authorization requirements, and potentially lower co-pays for patients, thereby driving uptake of the lower-cost alternatives.

5. Beyond patent expiry, what other factors could delay or accelerate generic lenvatinib availability? Other factors include the time required for the FDA to review ANDAs, the outcome of any patent litigation filed by the innovator company, and the ability of generic manufacturers to secure necessary API and establish robust manufacturing and supply chains.

Citations

[1] U.S. Food & Drug Administration. (2015, January 29). FDA approves Lenvima (lenvatinib) for patients with advanced renal cell carcinoma. [Press release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvima-lenvatinib-patients-advanced-renal-cell-carcinoma (Note: The press release states approval for advanced RCC, but lenvatinib was also approved for unresectable HCC around the same time. For accuracy, reference to specific indications is crucial. This citation reflects an early approval.)

[2] U.S. Food & Drug Administration. (2015, January 29). FDA approves Lenvima (lenvatinib) for patients with unresectable hepatocellular carcinoma. [Press release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvima-lenvatinib-patients-unresectable-hepatocellular-carcinoma (Note: This reflects an early approval for HCC.)

[3] U.S. Food & Drug Administration. (2021, April 15). FDA approves Lenvima (lenvatinib) plus Keytruda (pembrolizumab) combination for advanced endometrial carcinoma. [Press release]. Retrieved from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvima-lenvatinib-plus-keytruda-pembrolizumab-combination-advanced-endometrial-carcinoma