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Suppliers and packagers for generic pharmaceutical drug: LENVATINIB MESYLATE
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LENVATINIB MESYLATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947 | NDA | Eisai Inc. | 62856-704-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-704-30) / 5 CAPSULE in 1 BLISTER PACK (62856-704-05) | 2018-08-15 |
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947 | NDA | Eisai Inc. | 62856-708-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-708-30) / 10 CAPSULE in 1 BLISTER PACK (62856-708-05) | 2016-05-13 |
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947 | NDA | Eisai Inc. | 62856-710-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-710-30) / 5 CAPSULE in 1 BLISTER PACK (62856-710-05) | 2015-02-13 |
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947 | NDA | Eisai Inc. | 62856-712-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-712-30) / 15 CAPSULE in 1 BLISTER PACK (62856-712-05) | 2018-08-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LENVATINIB MESYLATE
Introduction
Lenvatinib mesylate is a targeted tyrosine kinase inhibitor (TKI) used primarily for the treatment of various cancers, including differentiated thyroid carcinoma, hepatocellular carcinoma, and renal cell carcinoma. Its unique mechanism of action, inhibiting multiple receptor tyrosine kinases involved in tumor growth and angiogenesis, has made it a vital asset in oncological therapies. Given its therapeutic importance, a global network of suppliers plays a critical role in ensuring the drug’s availability, quality, and regulatory compliance. This article examines the leading suppliers of lenvatinib mesylate, their manufacturing capabilities, and the dynamics shaping the supply chain.
Market Overview of Lenvatinib Mesylate Suppliers
Lenvatinib mesylate's original development and commercialization are primarily associated with Eisai Co., Ltd., a Japanese pharmaceutical giant that developed the drug under the brand name Lenvima. While Eisai remains the main global supplier, the complex nature of drug manufacturing – especially for oncology therapeutics – has engendered an expanding supply ecosystem, involving original manufacturers, contract manufacturing organizations (CMOs), and approved generic producers.
1. Original Manufacturer: Eisai Co., Ltd.
Eisai holds the patent rights to lenvatinib mesylate and is responsible for its formulation, production, and global distribution. Their manufacturing facilities in Japan and other regions are equipped with advanced processes that adhere to Good Manufacturing Practices (GMP). Eisai's strategic focus has involved patent protection, clinical trials, and global commercialization, ensuring they maintain a dominant supply position for lenvatinib mesylate.
2. Contract Manufacturing Organizations (CMOs)
Given the complexities and high costs of drug manufacturing, several pharmaceutical companies partner with CMOs to produce lenvatinib mesylate at scale. These organizations provide specialized synthesis and formulation capabilities, especially in regions where local regulations or economic factors necessitate local manufacturing. CMOs such as Samsung Biologics, Lonza, and WuXi AppTec are increasingly involved in biologics and small-molecule manufacturing, including oncology drugs like lenvatinib.
3. Generic Manufacturers and Biosimilar Producers
While patent protections limit generic manufacturing during the exclusivity period, generic firms seek to develop bioequivalent versions post-patent expiry. Countries like India, China, and several European nations are active in this domain. Notable generic producers include:
- Dr. Reddy’s Laboratories (India): Engaged in developing biosimilar and small-molecule oncology drugs, including efforts toward bioequivalent lenvatinib formulations.
- Zhejiang Huahai Pharmaceutical (China): Focuses on small-molecule manufacturing with capabilities to produce course-compliant formulations for international markets.
- Natco Pharma (India): Specializes in complex generic chemotherapeutic agents, aiming to expand the availability of affordable cancer treatments.
4. Supply Chain Disruptions and Regulatory Challenges
The COVID-19 pandemic revealed vulnerabilities in pharmaceutical supply chains, prompting increased scrutiny of reliance on a limited number of suppliers. Regulators such as the FDA and EMA emphasize the importance of diversified supplier bases for critical oncology drugs. Furthermore, regional regulatory frameworks influence manufacturing approvals, impacting supply pathways.
Manufacturing Processes and Quality Standards
Producing lenvatinib mesylate involves complex multi-step chemical synthesis, purification, and formulation processes that meet stringent GMP standards. Quality control (QC) measures include analytical verification of purity, bioactivity, and stability. Suppliers are required to maintain regulatory compliance to ensure drug safety and efficacy. Notably, the supply quality affects global access, pricing, and clinical outcomes.
Emerging Trends in the Supply of Lenvatinib Mesylate
- Localization of Production: To mitigate disruptions, companies are investing in regional manufacturing hubs. For example, some Asian producers are expanding facilities to meet growing domestic and international demands.
- Development of Biosimilars and Generics: As patent protections evolve, a proliferation of biosimilars and generics is anticipated, potentially lowering costs and increasing access.
- Regulatory Stringency: Governments and international bodies enforce rigorous standards, mandating regular inspections and compliance audits, which influence supplier stability.
- Technological Advancements: Innovations such as continuous manufacturing and process optimization are enhancing supply efficiency and quality.
Key Players in the Lenvatinib Mesylate Supply Chain
| Company | Role | Location | Capabilities | Remarks |
|---|---|---|---|---|
| Eisai Co., Ltd. | Original innovator | Japan | Development, manufacturing, distribution | Patent holder, primary global supplier |
| Samsung Biologics | CMO partner | South Korea | Large-scale synthesis, formulation | Increasing role in oncology drug manufacturing |
| WuXi AppTec | CMO | China | Synthesis, formulation, scale-up | Growing influence in Chinese and international markets |
| Dr. Reddy's Laboratories | Generic/biosimilar producer | India | Bioequivalent formulations | Expanding access post-patent expiry |
| Zhejiang Huahai Pharmaceutical | Generic small-molecule manufacturer | China | Manufacturing, quality control | Focused on export markets |
Regulatory and Geopolitical Factors
Supply chains are influenced profoundly by international trade policies, patent laws, and regional regulatory approvals. Recently, geopolitical tensions have affected the sourcing of raw materials and finished pharmaceuticals, prompting companies to diversify manufacturing sites to safeguard supply continuity.
Intellectual Property and Patent Lifecycle
Eisai’s patent protections for lenvatinib mesylate are set to expire progressively, enabling generic manufacturers to enter the market. This transition necessitates strategic planning for original manufacturers and offers opportunities for cost reductions and increased access in emerging markets.
Conclusion
The supply landscape for lenvatinib mesylate is characterized by a combination of patent-holding original manufacturers, global CMOs, and emerging generic producers. While Japan’s Eisai remains the dominant source, increasing regional manufacturing and the proliferation of biosimilars will influence supply dynamics. Ensuring supply resilience requires diversified sourcing, adherence to regulatory standards, and strategic partnerships across regions.
Key Takeaways
- Eisai Co., Ltd. is the primary global supplier of lenvatinib mesylate, holding patent rights and overseeing production and distribution.
- CMOs such as Samsung Biologics and WuXi AppTec play an expanding role in manufacturing, increasing production capacity and geographic diversity.
- Emerging generic manufacturers in India and China are preparing for post-patent markets, promising more affordable access.
- Supply chain resilience hinges on regional manufacturing, regulatory compliance, and diversification strategies amid geopolitical and logistical challenges.
- The upcoming patent expiry cycle will catalyze the entry of biosimilars and generics, reshaping the availability landscape.
FAQs
1. Who are the leading original producers of lenvatinib mesylate?
Eisai Co., Ltd. is the sole innovator and primary supplier, with manufacturing facilities in Japan and globally to support distribution.
2. Are generic versions of lenvatinib mesylate available?
Not commercially until the patent expires or is challenged. Once patent protections lapse, firms in India, China, and other countries are expected to develop bioequivalent formulations.
3. What role do contract manufacturing organizations (CMOs) play?
CMOs like Samsung Biologics and WuXi AppTec produce lenvatinib mesylate for original manufacturers, increasing supply capacity and geographic reach.
4. How does regulation affect the supply of lenvatinib mesylate?
Regulatory standards influence manufacturing practices and approval processes, impacting supplier stability and product quality globally.
5. What are the risks to the supply chain for lenvatinib mesylate?
Potential risks include geopolitical tensions, manufacturing disruptions, raw material shortages, and changes in patent or regulatory environments.
References
[1] Eisai Co., Ltd. Official Website. (2023). Lenvatinib Product Details.
[2] US Food and Drug Administration (FDA). Guidance on Oncology Drug Manufacturing.
[3] IQVIA Institute. (2022). The Future of Oncology Biosimilars and Generics.
[4] WuXi AppTec. Capabilities in Small Molecule Synthesis.
[5] GlobalData. (2023). Pharmaceutical Contract Manufacturing Market Outlook.
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