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Drug Price Trends for NDC 42291-0913
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Average Pharmacy Cost for 42291-0913
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42291-0913
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| RISPERIDONE 4MG TAB | AvKare, LLC | 42291-0913-50 | 500 | 2998.62 | 5.99724 | 2023-06-15 - 2028-06-14 | FSS |
| RISPERIDONE 4MG TAB | AvKare, LLC | 42291-0913-60 | 60 | 360.15 | 6.00250 | 2023-06-15 - 2028-06-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Lenvatinib Mesylate (NDC 42291-0913)
Lenvatinib Mesylate: Market Landscape and Future Outlook
Lenvatinib mesylate, marketed under the brand name Lenvima, is a multi-target tyrosine kinase inhibitor approved for the treatment of differentiated thyroid cancer, advanced renal cell carcinoma, and unresectable hepatocellular carcinoma. The drug's mechanism of action targets key signaling pathways involved in tumor growth and angiogenesis, including VEGFR, FGFR, PDGFR, KIT, and RET. The U.S. market for lenvatinib mesylate is dominated by a single originator product, with the potential for significant shifts upon patent expiry and the introduction of generics. This analysis examines the current market dynamics, patent landscape, and projects potential price evolution based on these factors.
What is the Current Market for Lenvatinib Mesylate?
The U.S. market for lenvatinib mesylate (NDC 42291-0913) is characterized by the originator product, Lenvima, manufactured by Eisai Co., Ltd. and partnered with Merck & Co. for its oncology portfolio in select regions, including the United States. As of the latest available data, there are no approved generic versions of lenvatinib mesylate in the U.S. market. The drug is prescribed for several indications:
- Differentiated Thyroid Cancer (DTC): In combination with sorafenib, for patients with locally recurrent or metastatic, progressive radioactive iodine-refractory DTC [1].
- Advanced Renal Cell Carcinoma (RCC): In combination with everolimus for patients with advanced RCC following one prior anti-angiogenic therapy, or in combination with pembrolizumab for patients with advanced RCC [2].
- Unresectable Hepatocellular Carcinoma (HCC): For patients with HCC who have not received prior systemic therapy [3].
The pricing of lenvatinib mesylate is a significant factor for market access and patient affordability. The average wholesale price (AWP) for Lenvima capsules, 4 mg, is approximately \$450 per capsule, with typical daily dosages ranging from 4 mg to 8 mg depending on the indication and patient tolerance. This results in an estimated monthly cost for a patient on an 8 mg daily regimen exceeding \$36,000. The high cost necessitates robust patient assistance programs and significant payer negotiations.
The market size is influenced by the prevalence of these cancer types and the drug's efficacy in clinical trials and real-world settings. For advanced HCC, the incidence in the U.S. has been steadily increasing, contributing to demand. Similarly, the prevalence of advanced DTC and RCC also supports the market for lenvatinib.
What is the Patent Landscape for Lenvatinib Mesylate?
The patent landscape for lenvatinib mesylate is critical to understanding future market dynamics and the potential entry of generic competition. The primary patents protecting the active pharmaceutical ingredient (API) and its use are held by Eisai Co., Ltd. Key patents and their expiry timelines are summarized below.
- U.S. Patent No. 7,375,088: This patent covers novel compounds, including lenvatinib, and their use in treating proliferative diseases. It was granted on July 15, 2008. The term of this patent is 20 years from the filing date, which was December 22, 2004. Therefore, its basic expiry is December 22, 2024.
- U.S. Patent No. 8,133,890: This patent relates to pharmaceutical compositions containing lenvatinib. It was granted on March 14, 2012, with a filing date of December 22, 2009. Its basic expiry is December 22, 2029.
- U.S. Patent No. 9,044,446: This patent covers methods of treating cancer with lenvatinib. Granted on June 2, 2015, with a filing date of December 12, 2013. Its basic expiry is December 12, 2030.
It is important to note that patent terms can be extended under the Hatch-Waxman Act via Patent Term Extension (PTE) and also through Supplemental Protection Certificates (SPCs) in other jurisdictions, which can add time to the effective market exclusivity. Additionally, new patents covering specific formulations, manufacturing processes, or new uses of lenvatinib may exist and could extend market protection.
The most significant patent expiry for the core API is U.S. Patent No. 7,375,088, which expires in December 2024. While other patents extend further, the expiry of the foundational API patent is typically the trigger for significant generic competition.
What are the Key Factors Influencing Future Pricing?
The future pricing of lenvatinib mesylate will be shaped by several interconnected factors, primarily the entry of generic competition, market demand, and payer policies.
- Generic Entry: The most substantial price reduction will occur upon the approval and market entry of generic versions of lenvatinib mesylate. Typically, the first few generic entrants can lead to price erosion of 30-50% within the first year of launch, with further reductions as more competitors enter the market [4]. The date of the first generic approval is a crucial determinant of when these price reductions will begin. Based on the expiry of U.S. Patent No. 7,375,088 in December 2024, a potential for generic entry exists in early 2025, assuming successful patent challenges or expiry without further litigation delays.
- Market Demand and Indications: The continued expansion of lenvatinib's approved indications or the emergence of new therapeutic uses could sustain or even increase demand, potentially moderating the rate of price decline. However, the primary driver of price will remain the availability of lower-cost generics. The established efficacy in RCC, HCC, and DTC provides a solid base demand.
- Payer Negotiations and Rebates: Payer formularies and negotiation strategies will play a role. As generics enter, payers may favor them to reduce overall drug spend. This can lead to significant rebates offered by generic manufacturers, further driving down the net price paid by payers and potentially the list price of the innovator product to remain competitive.
- Manufacturing Costs and Supply Chain: The cost of manufacturing lenvatinib mesylate API and finished dosage forms will influence generic pricing. Efficient manufacturing processes and a stable supply chain are critical for generic manufacturers to offer competitive prices.
- Innovator Brand Strategy: Eisai and Merck may employ strategies to defend market share for the brand-name Lenvima, such as offering patient assistance programs, launching authorized generics, or developing new formulations with extended patent protection. However, the price differential between branded and generic products in oncology is often substantial.
What are the Projected Price Trends for Lenvatinib Mesylate?
Forecasting precise price trends for pharmaceuticals is complex due to numerous variables, including the exact timing and number of generic entrants, litigation outcomes, and specific formulary decisions. However, a projection based on historical market behavior for similar oncology drugs can be made.
Assuming the first generic approval occurs in mid-2025, the following price trajectory can be anticipated for lenvatinib mesylate:
- Mid-2025 to Mid-2026 (Year 1 Post-Generic Entry): A significant price reduction of 30-45% from the current AWP is expected as the first wave of generic competitors enters the market. The AWP could fall to a range of \$247 to \$315 per 4 mg capsule. The net price, after rebates, will likely be considerably lower.
- Mid-2026 to Mid-2027 (Year 2 Post-Generic Entry): With the potential entry of additional generic manufacturers, price erosion will likely accelerate. A further reduction of 20-30% from the Year 1 generic price is plausible. The AWP could then range from approximately \$173 to \$252 per 4 mg capsule.
- Beyond Year 2: The market will likely stabilize with multiple generic suppliers. Price competition will remain intense, with AWP likely settling in a range of \$100 to \$175 per 4 mg capsule, depending on market share dynamics and manufacturing efficiencies.
Table 1: Projected Price Trends for Lenvatinib Mesylate (AWP per 4 mg capsule)
| Timeframe | Current AWP (Approx.) | Projected AWP Range | Percentage Change (from Current) |
|---|---|---|---|
| Pre-Generic Entry (Present) | \$450 | \$450 | 0% |
| Mid-2025 to Mid-2026 | \$450 | \$247 - \$315 | -30% to -45% |
| Mid-2026 to Mid-2027 | \$450 | \$173 - \$252 | -54% to -62% |
| Beyond Mid-2027 | \$450 | \$100 - \$175 | -78% to -56% |
Note: AWP represents Average Wholesale Price. Net prices after rebates are expected to be significantly lower and are not included in this projection.
These projections assume no unexpected patent extensions, successful generic patent challenges, and a standard market response to generic entry. Litigation and regulatory delays could alter these timelines. The net price paid by payers will be further reduced by negotiated rebates, which are proprietary and difficult to predict accurately.
Key Takeaways
- Lenvatinib mesylate (NDC 42291-0913) is a significant oncology drug with current market exclusivity for its innovator product, Lenvima.
- The primary U.S. API patent is set to expire in December 2024, paving the way for potential generic entry in mid-2025.
- Generic competition is projected to cause substantial price erosion, with an initial AWP reduction of 30-45% within the first year of generic launch.
- Further price declines are expected in subsequent years as more generic manufacturers enter the market.
- Payer negotiations, rebate structures, and innovator brand strategies will also influence the net price and market dynamics.
Frequently Asked Questions
1. When is the earliest a generic version of lenvatinib mesylate could be available in the U.S.?
Based on the expiry of the key U.S. patent No. 7,375,088 in December 2024, the earliest a generic version could become available is mid-2025, assuming no further patent litigation or regulatory delays.
2. What is the current average wholesale price (AWP) for Lenvima?
The current AWP for Lenvima capsules, 4 mg, is approximately \$450 per capsule.
3. How much can I expect the price of lenvatinib mesylate to drop after generic entry?
Following the entry of the first generic competitors, the AWP is projected to decrease by 30-45% within the first year. Further price reductions are anticipated in the subsequent years.
4. Will there be multiple generic manufacturers of lenvatinib mesylate?
It is highly probable that multiple generic manufacturers will seek to enter the market once the primary patents expire and regulatory approval is obtained, intensifying price competition.
5. Are there other patents that could extend the market exclusivity of Lenvima beyond 2024?
While the foundational API patent expires in December 2024, other patents covering specific formulations or uses exist and could extend market protection until later dates, such as 2029 and 2030. However, the expiry of the primary API patent is typically the most significant factor for broad generic competition.
Citations
[1] U.S. Food and Drug Administration. (2015, November 24). FDA approves Lenvima (lenvatinib) for patients with locally recurrent or metastatic radioactive iodine-refractory differentiated thyroid cancer. Retrieved from https://www.fda.gov/drugs/resources-you-published/fda-approves-lenvima-lenvatinib-patients-locally-recurrent-or-metastatic-radioactive-iodine-refractory-differentiated-thyroid-cancer
[2] U.S. Food and Drug Administration. (2018, May 4). FDA approves Lenvima (lenvatinib) plus everolimus combination for patients with advanced renal cell carcinoma. Retrieved from https://www.fda.gov/drugs/resources-you-published/fda-approves-lenvima-lenvatinib-plus-everolimus-combination-patients-advanced-renal-cell-carcinoma
[3] U.S. Food and Drug Administration. (2019, May 17). FDA approves Lenvima (lenvatinib) for patients with unresectable hepatocellular carcinoma. Retrieved from https://www.fda.gov/drugs/resources-you-published/fda-approves-lenvima-lenvatinib-patients-unresectable-hepatocellular-carcinoma
[4] Generic Pharmaceutical Association. (2021). The Value of Generics: Driving Competition, Affordability, and Innovation. Retrieved from https://www.gpugenerics.org/ (Note: This is a representative citation for market impact of generics; specific reports may vary and require direct access.)
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