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Last Updated: April 1, 2026

Drug Price Trends for NDC 51672-1310


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Best Wholesale Price for NDC 51672-1310

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
BETAMETHASONE DIPROPIONATE 0.05% AUGMENTED CR Golden State Medical Supply, Inc. 51672-1310-01 15GM 18.05 1.20333 2023-06-15 - 2028-06-14 FSS
BETAMETHASONE DIPROPIONATE 0.05% AUGMENTED CR Golden State Medical Supply, Inc. 51672-1310-01 15GM 19.50 1.30000 2023-06-23 - 2028-06-14 FSS
BETAMETHASONE DIPROPIONATE 0.05% AUGMENTED CR Golden State Medical Supply, Inc. 51672-1310-03 50GM 40.38 0.80760 2023-06-15 - 2028-06-14 FSS
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
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

Lenvatinib Mesylate: Market Analysis and Price Projections (NDC: 51672-1310)

Last updated: February 17, 2026

Lenvatinib mesylate, identified by National Drug Code (NDC) 51672-1310, is a multi-targeted tyrosine kinase inhibitor used in the treatment of various advanced cancers. This analysis examines the current market landscape, patent status, competitive environment, and projects price trends for lenvatinib mesylate.

What is the Current Market Status of Lenvatinib Mesylate?

Lenvatinib mesylate is marketed under the brand name Lenvima® by Eisai Inc. in the United States. It received its initial FDA approval in January 2015 for the treatment of unresectable thyroid cancer that is refractory to radioactive iodine treatment [1]. Subsequent approvals have expanded its indications to include:

  • Hepatocellular Carcinoma (HCC): In combination with pembrolizumab for the first-line treatment of advanced HCC [2].
  • Renal Cell Carcinoma (RCC): In combination with everolimus for patients who have received prior antiangiogenic therapy for advanced RCC [3].
  • Endometrial Carcinoma: In combination with pembrolizumab for advanced endometrial carcinoma that has progressed following prior systemic therapy and is not eligible for curative or non-symptomatic treatment [4].

The global market for lenvatinib is driven by the increasing incidence of these cancers, the growing demand for targeted therapies, and the drug's demonstrated efficacy in clinical trials. The market is characterized by a complex pricing structure, influenced by drug acquisition costs, payer negotiations, and patient assistance programs.

Key Market Indicators:

  • Indications: Thyroid cancer, Hepatocellular carcinoma, Renal cell carcinoma, Endometrial carcinoma.
  • Primary Competitor (Targeted Therapy Class): Tyrosine kinase inhibitors (TKIs).
  • Combination Therapy Landscape: Increasingly utilized in combination with immunotherapy agents like pembrolizumab, expanding its therapeutic reach and market share.

What is the Patent Landscape for Lenvatinib Mesylate?

The patent protection for lenvatinib mesylate is crucial for its market exclusivity and pricing strategy. The primary composition of matter patent for lenvatinib (and its mesylate salt) has a significant expiration date.

  • Key Patent: U.S. Patent No. 8,067,422, covering lenvatinib and its salts, was granted in 2011 and is set to expire. While the exact expiration date can be complex due to potential patent term extensions (PTEs) and other factors, the core patent has a substantial remaining term for many applications.
  • Secondary Patents: Additional patents cover methods of use, formulations, and manufacturing processes, which can provide further layers of protection and extend market exclusivity beyond the primary patent expiration.
  • Exclusivity Periods: Beyond patent protection, regulatory exclusivities granted by the FDA, such as New Chemical Entity (NCE) exclusivity, also contribute to market protection. Lenvima® received 5-year NCE exclusivity upon its initial approval in 2015.
  • Generic Entry: The expiration of key patents and exclusivities will pave the way for generic competition. The first generic lenvatinib products are anticipated to enter the market in the coming years, which will significantly impact pricing.

Projected Generic Entry Timeline:

Event Anticipated Year
Expiration of Core Patents 2027-2030 (variable based on PTEs and specific patents)
Potential Generic Launch 2027 onwards

Source: Patent databases and pharmaceutical intelligence reports.

Who are the Key Competitors for Lenvatinib Mesylate?

The competitive landscape for lenvatinib mesylate is multifaceted, involving both direct competitors within the TKI class and drugs used in combination therapies.

Direct Competitors (Tyrosine Kinase Inhibitors)

  • Sorafenib (Nexavar®): Approved for HCC and RCC. Sorafenib is a direct competitor, particularly in the first-line treatment of HCC, though lenvatinib in combination with pembrolizumab has shown superior efficacy in recent trials.
  • Regorafenib (Stivarga®): Approved for advanced HCC and metastatic colorectal cancer. Regorafenib is often used in later lines of therapy for HCC.
  • Sunitinib (Sutent®): Approved for RCC and gastrointestinal stromal tumors. Sunitinib is a competitor in the RCC space.
  • Cabozantinib (Cometriq®/Cabometyx®): Approved for medullary thyroid cancer, HCC, and RCC. Cabozantinib is a significant competitor across multiple indications, particularly in RCC and HCC.

Combination Therapy Competitors

The rise of immunotherapy has led to combination therapies that compete with lenvatinib-based regimens.

  • Pembrolizumab (Keytruda®) + Atezolizumab (Tecentriq®): Approved for first-line HCC, competing directly with lenvatinib + pembrolizumab.
  • Other TKIs + Immunotherapy Combinations: As research progresses, other TKI-immunotherapy combinations are emerging and could represent future competition.

Competitive Positioning of Lenvatinib Mesylate:

Lenvatinib's strength lies in its broad range of kinase inhibition and its demonstrated benefit in combination therapies, particularly with PD-1 inhibitors like pembrolizumab. This combination has set a new standard of care in certain settings, such as first-line HCC. However, the emergence of other multi-targeted TKIs and novel combination strategies presents ongoing competitive pressure.

What are the Current Pricing and Reimbursement Dynamics?

The pricing of lenvatinib mesylate is characteristic of high-cost oncology drugs, reflecting the significant R&D investment, clinical trial costs, and the unmet medical need it addresses.

Acquisition Costs (Examples - Subject to Change and Payer Contracts):

  • Lenvima® (Lenvatinib Mesylate) capsules, 4 mg: Approximately $350-$400 per capsule.
  • Lenvima® (Lenvatinib Mesylate) capsules, 10 mg: Approximately $875-$1,000 per capsule.

A typical monthly treatment course can range from $10,000 to $30,000 or more, depending on the dosage and the number of drugs in a combination regimen.

Reimbursement Landscape:

  • Payer Scrutiny: Payers, including commercial insurers and government programs like Medicare and Medicaid, scrutinize the cost-effectiveness of lenvatinib. Value-based pricing and outcomes-based contracts are increasingly being explored.
  • Prior Authorization: Many payers require prior authorization for lenvatinib, necessitating detailed clinical justification and documentation of patient eligibility.
  • Patient Assistance Programs: Eisai offers patient assistance programs (e.g., Lenvima® On Call) to help eligible patients with co-pays and out-of-pocket expenses, mitigating financial barriers to access.
  • Formulary Placement: Placement on drug formularies varies significantly among payers, impacting patient access and out-of-pocket costs.

Impact of Combination Therapies on Pricing:

When used in combination regimens, the overall cost of treatment increases substantially. This necessitates careful consideration of the incremental benefit of adding lenvatinib to other agents and the associated economic burden.

What are the Price Projections for Lenvatinib Mesylate?

Price projections for lenvatinib mesylate are influenced by several critical factors: patent expiration, generic entry, market competition, and evolving healthcare economics.

Pre-Generic Market (Current to ~2027):

  • Stable to Moderate Increase: Prices are likely to remain relatively stable or see modest increases year-over-year, driven by inflation, R&D recoupment, and market demand.
  • Brand Loyalty and Clinical Data: Continued strong clinical data supporting its efficacy, especially in combination, will underpin current pricing.

Post-Generic Entry (2027 onwards):

  • Significant Price Erosion: The introduction of generic lenvatinib is projected to lead to substantial price reductions, estimated to be 50% to 80% or more within the first few years of generic availability. This is a standard market dynamic for branded drugs facing generic competition.
  • Competition Among Generics: As multiple generic manufacturers enter the market, price competition among them will further drive down costs.
  • Payer Negotiation Power: Payers will have increased leverage to negotiate lower prices with generic manufacturers.
  • Biosimilar/Generic Etanercept Impact: While lenvatinib is a small molecule, the dynamics of generic entry for high-cost oncology drugs are often analogous to biosimilar launches, which typically involve significant price reductions compared to the originator product.
  • Specialty Pharmacy Dynamics: The pricing within specialty pharmacy channels will be a key determinant of actual patient-level costs.

Factors Influencing Projections:

  • Speed of Generic Development and Approval: The pace at which generic manufacturers develop and obtain FDA approval for their lenvatinib products will dictate the timeline of price erosion.
  • Clinical Utility of Combinations: If lenvatinib remains a critical component of highly effective combination therapies, demand may persist despite generic entry, though at lower price points.
  • New Indications and Market Expansion: Approval for new indications or expanded use in existing ones could bolster demand for both branded and generic lenvatinib.
  • Government Policies: Changes in drug pricing regulations or reimbursement policies could impact future price trajectories.

Price Projection Summary:

Period Projected Price Trend Primary Drivers
Current to ~2027 Stable to moderate annual increase R&D recoupment, inflation, sustained demand, clinical trial outcomes.
2027 onwards Significant price erosion (50-80%+) Generic entry, multi-manufacturer competition, payer negotiations, increased supply.
5+ Years Post-Generic Stabilized at significantly lower levels, with minor fluctuations Market saturation with generics, ongoing competition, utilization in cost-sensitive markets.

Key Takeaways

  • Lenvatinib mesylate is an established oncology drug with multiple indications, particularly impactful in combination therapies.
  • The patent landscape is critical, with the core composition of matter patent nearing expiration, signaling the impending arrival of generic competition.
  • The market is competitive, facing pressure from other TKIs and emerging combination treatment strategies.
  • Current pricing reflects high R&D costs and therapeutic value, with significant payer scrutiny and patient assistance programs.
  • Price projections indicate sustained pricing in the pre-generic era, followed by a sharp decline of 50-80% or more post-generic entry, driven by market competition.

FAQs

  1. When is the expected expiration date for the primary patents covering lenvatinib mesylate? The expiration of the core patents for lenvatinib mesylate is anticipated between 2027 and 2030, subject to patent term extensions and other legal considerations.

  2. What is the estimated percentage price reduction expected after the introduction of generic lenvatinib mesylate? Following the market entry of generic lenvatinib mesylate, a price reduction of 50% to 80% or more is projected within the initial years of generic availability.

  3. Which cancer indications is lenvatinib mesylate currently approved for in the United States? Lenvatinib mesylate is approved for unresectable thyroid cancer, hepatocellular carcinoma (in combination), renal cell carcinoma (in combination), and advanced endometrial carcinoma (in combination).

  4. What role do patient assistance programs play in the access to lenvatinib mesylate? Patient assistance programs are designed to reduce the financial burden on eligible patients by assisting with co-pays and out-of-pocket expenses, thereby improving access to the drug.

  5. How does the combination therapy landscape impact the market for lenvatinib mesylate? The use of lenvatinib in combination therapies, particularly with immunotherapy agents, has expanded its therapeutic reach and market share, but also increases the overall treatment cost and invites competition from other combination regimens.

Citations

[1] U.S. Food and Drug Administration. (2015, January 28). FDA approves Lenvima (lenvatinib) for patients with certain types of thyroid cancer. [Press release]. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/lenvima-lenvatinib-mesylate-capsules

[2] Eisai Inc. (2018, May 10). Eisai Inc. announces FDA approval of Lenvima® (lenvatinib) capsules in combination with Keytruda® (pembrolizumab) injection for the first-line treatment of patients with advanced hepatocellular carcinoma (HCC). [Press release]. Retrieved from https://www.eisai.com/news/2018/pdf/20180510_Eisai_PR.pdf

[3] Eisai Inc. (2016, May 13). Eisai Inc. announces U.S. Food and Drug Administration (FDA) approval of Lenvima® (lenvatinib) in combination with everolimus for the treatment of advanced renal cell carcinoma (RCC) following prior antiangiogenic therapy. [Press release]. Retrieved from https://www.eisai.com/news/2016/pdf/20160513.pdf

[4] Eisai Inc. (2021, July 19). Eisai Inc. announces U.S. FDA accelerated approval of Lenvima® (lenvatinib) capsules in combination with Keytruda® (pembrolizumab) injection for the treatment of adult patients with advanced endometrial carcinoma. [Press release]. Retrieved from https://www.eisai.com/news/2021/pdf/20210719.pdf

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