Suppliers and packagers for generic pharmaceutical drug: LENVATINIB MESYLATE

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
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947	NDA	Eisai Inc.	62856-714-30	6 BLISTER PACK in 1 BOX (62856-714-30) / 1 KIT in 1 BLISTER PACK (62856-714-05)	2015-02-13
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947	NDA	Eisai Inc.	62856-718-30	6 BLISTER PACK in 1 BOX (62856-718-30) / 1 KIT in 1 BLISTER PACK (62856-718-05)	2016-05-13

Lenvatinib Mesylate: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

Lenvatinib mesylate is an orally available kinase inhibitor used in the treatment of certain types of cancer, including thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma. The drug's efficacy is attributed to its ability to inhibit multiple receptor tyrosine kinases, including vascular endothelial growth factor receptors (VEGFR1-3), fibroblast growth factor receptors (FGFR1-4), platelet-derived growth factor receptor alpha (PDGFRA), KIT, and RET proto-oncogene. Echos of lenvatinib's mechanism of action and its therapeutic applications are found in multiple patent filings.

Who Manufactures Lenvatinib Mesylate API?

The Active Pharmaceutical Ingredient (API) for lenvatinib mesylate is primarily manufactured by a select group of global pharmaceutical chemical suppliers. These entities possess the specialized capabilities and regulatory compliance required for the production of complex oncology drug substances.

• Eisai Co., Ltd. (Japan): As the innovator company, Eisai is the primary developer and marketer of lenvatinib mesylate. They maintain strict control over API manufacturing, often through captive production or closely managed contract manufacturing organizations (CMOs).
• Lonza Group AG (Switzerland): Lonza is a significant global supplier of API manufacturing services and has been involved in the production of various oncology drugs. Their capabilities align with the stringent quality and regulatory requirements for lenvatinib mesylate.
• WuXi AppTec Co., Ltd. (China): This prominent contract research, development, and manufacturing organization (CRDMO) offers comprehensive services to the pharmaceutical industry, including API synthesis. Their participation in the supply chain for complex APIs like lenvatinib mesylate is notable.
• Hengrui Medicine Co., Ltd. (China): Hengrui is a major Chinese pharmaceutical company with significant R&D and manufacturing capacity. They are increasingly involved in the global API supply chain for both branded and generic pharmaceuticals.

The manufacturing process for lenvatinib mesylate API involves multi-step organic synthesis, requiring precise control over reaction conditions, purification, and analytical testing. Key considerations for API suppliers include adherence to Good Manufacturing Practices (GMP), robust quality control systems, and the ability to scale production to meet global demand.

What are the Key Patents for Lenvatinib Mesylate?

The patent landscape surrounding lenvatinib mesylate is characterized by a series of innovator patents protecting the compound itself, its synthesis, pharmaceutical compositions, and methods of use. These patents are crucial for understanding market exclusivity and the potential for generic competition.

Compound and Composition Patents

The core patents protect the lenvatinib compound and its mesylate salt form, which is the active ingredient in the marketed drug.

• US Patent 9,504,714 B2: This patent, titled "Preparation of lenvatinib mesylate," describes improved processes for manufacturing lenvatinib mesylate. It was granted on November 29, 2016, and its expiry is critical for generic entry.
• US Patent 8,748,445 B2: This patent, titled "Lenvatinib crystalline forms," covers specific crystalline forms of lenvatinib mesylate. It was granted on June 10, 2014.
• US Patent 8,420,673 B2: Titled "Lenvatinib and use thereof," this patent covers the lenvatinib compound itself and its use in treating proliferative diseases. It was granted on April 16, 2013.
• EP 1475397 B1: This European patent, titled "Lenvatinib and use thereof," claims the lenvatinib compound and its medical applications.

The expiry dates of these foundational patents are subject to various extensions, including patent term extensions (PTE) for regulatory delays and potential extensions for pediatric exclusivity.

Method of Use Patents

Patents also cover specific indications and dosing regimens for lenvatinib mesylate.

• US Patent 9,694,026 B2: Titled "Method for treating cancer using lenvatinib," this patent claims methods for treating specific cancers, including differentiated thyroid cancer. Granted on July 4, 2017.
• US Patent 10,596,174 B2: This patent, titled "Combination therapy for renal cell carcinoma," claims combination therapies involving lenvatinib for renal cell carcinoma. Granted on March 17, 2020.
• WO 2014/184426 A1: This international application, titled "Lenvatinib for use in the treatment of cancer," covers specific treatment regimens.

These method of use patents can extend market exclusivity for particular indications even after the compound patent expires, by protecting novel therapeutic applications.

What is the Generic Landscape for Lenvatinib Mesylate?

The generic landscape for lenvatinib mesylate is developing as key patents approach or pass their expiration dates. The entry of generic versions is contingent on navigating the existing patent protections and securing regulatory approvals.

• ANDA Filings: The U.S. Food and Drug Administration (FDA) Abbreviated New Drug Application (ANDA) process is the pathway for generic drug approval. Companies file ANDAs to demonstrate that their generic product is bioequivalent to the reference listed drug (RLD), in this case, Eisai's Lenvima.
• Patent Litigation: Challenges to innovator patents, such as Paragraph IV certifications under the Hatch-Waxman Act in the U.S., are common. These legal battles can significantly impact the timing of generic market entry. For lenvatinib mesylate, litigation has focused on key composition and method of use patents.
• Key Generic Players: Several generic pharmaceutical companies are positioning themselves to enter the lenvatinib mesylate market. These include:
  • Dr. Reddy's Laboratories Ltd. (India): Has been actively pursuing generic approvals for lenvatinib mesylate.
  • Sun Pharmaceutical Industries Ltd. (India): A major global generic player with capabilities in complex oncology generics.
  • Cipla Ltd. (India): Another significant Indian pharmaceutical company with a strong generic portfolio.
  • Teva Pharmaceutical Industries Ltd. (Israel): A leading global generic manufacturer with a broad range of oncology products.

The market dynamics will be influenced by the number of authorized generic (AG) versions and the speed at which regulatory bodies approve ANDAs. Generic pricing is expected to be significantly lower than the innovator product, driving increased patient access.

What are the Regulatory Considerations for Lenvatinib Mesylate?

The manufacture, sale, and marketing of lenvatinib mesylate are subject to stringent regulatory oversight by health authorities worldwide. These regulations ensure the safety, efficacy, and quality of the drug product.

• FDA (United States): The FDA approves new drug applications (NDAs) and ANDAs. It also enforces GMP regulations through facility inspections. The approval of Lenvima for various indications has been a key regulatory milestone.
• EMA (Europe): The European Medicines Agency (EMA) is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the European Union. Marketing authorization is granted through centralized or decentralized procedures.
• PMDA (Japan): The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan oversees drug approvals and post-market surveillance. Eisai's initial approvals were secured in Japan.
• GMP Compliance: All manufacturing facilities involved in the production of lenvatinib mesylate API and finished drug products must comply with current Good Manufacturing Practices (cGMP). This includes rigorous quality control, documentation, and validation procedures.
• Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files to regulatory agencies. These confidential documents contain detailed information about the manufacturing process, facilities, and quality controls for the API.

Regulatory filings for generic lenvatinib mesylate must demonstrate equivalence to the reference product and adhere to all relevant regulatory guidelines.

How Does the Patent Expiration Impact Market Competition?

The expiration of primary patents for lenvatinib mesylate is a critical trigger for increased market competition. The impact is multifaceted, affecting pricing, market share, and R&D strategies.

• Price Erosion: The introduction of generic versions of lenvatinib mesylate will lead to significant price reductions. This is a direct consequence of competition from multiple manufacturers offering lower-cost alternatives. The typical price drop post-generic entry can range from 50% to 85%, depending on the drug class and market dynamics.
• Increased Accessibility: Lower prices enhance patient access to lenvatinib mesylate, particularly in healthcare systems with budget constraints. This can lead to increased treatment rates for the approved indications.
• Market Share Shift: The market share held by the innovator company, Eisai, will gradually decline as generic products gain traction. The speed of this shift depends on the number of generic competitors, their marketing efforts, and formulary placements by payers.
• Sustained Innovation: For innovator companies, patent expiry necessitates a focus on developing new formulations, combination therapies, or next-generation drugs to maintain a competitive edge and revenue streams. Eisai's strategy may involve exploring new indications or optimizing existing treatment regimens.
• Generic R&D Investment: The prospect of patent expiry incentivizes generic manufacturers to invest in R&D for lenvatinib mesylate. This includes developing bioequivalent formulations and navigating the complex regulatory and intellectual property pathways.

The timeline for patent expiration and subsequent generic entry is a key factor in strategic planning for both innovator and generic pharmaceutical companies, as well as for investors and healthcare providers. The interplay between patent law, regulatory approvals, and market forces will define the competitive landscape for lenvatinib mesylate.

Key Takeaways

• Lenvatinib mesylate API is primarily manufactured by a limited number of specialized global pharmaceutical chemical suppliers, with Eisai Co., Ltd. being the innovator and primary controller.
• The patent landscape is characterized by core compound and composition patents, as well as method of use patents, with expiry dates dictating the potential for generic entry. Key patents include US 9,504,714 B2, US 8,748,445 B2, and US 8,420,673 B2.
• The generic landscape is actively developing, with companies like Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, Cipla, and Teva Pharmaceutical Industries preparing to enter the market following patent expiries and successful ANDA filings.
• Regulatory bodies such as the FDA, EMA, and PMDA oversee the approval and manufacturing of lenvatinib mesylate, with strict adherence to GMP being paramount.
• Patent expiration is expected to lead to significant price erosion, increased accessibility, and a shift in market share from the innovator to generic manufacturers, necessitating ongoing innovation strategies for all stakeholders.

Frequently Asked Questions

1. When is the primary patent for lenvatinib mesylate expected to expire in major markets like the U.S. and Europe? The expiry of key patents like US 8,420,673 B2 (granted April 16, 2013) and US 9,504,714 B2 (granted November 29, 2016) is a critical factor. However, specific expiry dates can be complex due to potential patent term extensions, reissues, and the duration of method of use patents, requiring detailed analysis of each specific patent and its legal status.

2. Which contract manufacturing organizations (CMOs) are authorized by Eisai to produce lenvatinib mesylate API? Information regarding specific authorized CMOs is proprietary and not publicly disclosed by Eisai. However, companies with advanced capabilities in complex API synthesis and a strong regulatory track record, such as Lonza and WuXi AppTec, are typically involved in such supply chains, either directly or indirectly.

3. What are the typical challenges faced by generic manufacturers when seeking approval for lenvatinib mesylate? Generic manufacturers face challenges including demonstrating bioequivalence to the reference listed drug, navigating complex patent landscapes through Paragraph IV certifications and potential litigation, securing robust supply chains for API, and meeting stringent regulatory requirements for quality and manufacturing.

4. Are there any notable patent disputes or litigations currently underway concerning lenvatinib mesylate? Patent litigation is common in the pharmaceutical industry. While specific ongoing disputes can change rapidly, challenges to Eisai's patents by generic companies, particularly concerning compound, formulation, and method of use patents, are anticipated and have likely occurred as companies prepare for market entry.

5. Beyond the major markets (US, EU, Japan), which other regions are significant for lenvatinib mesylate sales and potential generic competition? Significant markets also include China, Canada, Australia, and various emerging markets in Asia, Latin America, and Eastern Europe. The regulatory pathways and patent protection durations in these regions will also influence the timing and extent of generic competition.

Citations

[1] Eisai Co., Ltd. (2016, November 29). Preparation of lenvatinib mesylate. U.S. Patent No. 9,504,714 B2. [2] Eisai Co., Ltd. (2014, June 10). Lenvatinib crystalline forms. U.S. Patent No. 8,748,445 B2. [3] Eisai Co., Ltd. (2013, April 16). Lenvatinib and use thereof. U.S. Patent No. 8,420,673 B2. [4] Eisai Co., Ltd. (2014, March 05). Lenvatinib and use thereof. European Patent EP 1475397 B1. [5] Eisai Co., Ltd. (2017, July 04). Method for treating cancer using lenvatinib. U.S. Patent No. 9,694,026 B2. [6] Eisai Co., Ltd. (2020, March 17). Combination therapy for renal cell carcinoma. U.S. Patent No. 10,596,174 B2. [7] Eisai Co., Ltd. (2014, December 18). Lenvatinib for use in the treatment of cancer. World Intellectual Property Organization PCT/JP2014/066701.