How India Exports Lenvatinib to the World

As of March 2026, lenvatinib is approved in the United States under the brand name Lenvima, marketed by Eisai Co., Ltd. The U.S. Food and Drug Administration (FDA) granted initial approval for lenvatinib in February 2015 for the treatment of differentiated thyroid cancer. Subsequent approvals expanded its indications to include hepatocellular carcinoma in August 2018.

Regarding generic competition, Eisai has actively defended its intellectual property rights. In May 2025, the U.S. District Court for the District of New Jersey ruled in favor of Eisai in a patent infringement lawsuit against Shilpa Medicare Limited, preventing the approval of Shilpa's generic version of lenvatinib until after the patent's expiration in February 2036.

Given the absence of approved generic versions, the U.S. market for lenvatinib remains exclusive to the brand-name product. This exclusivity, coupled with the complex regulatory and patent landscape, presents challenges for Indian exporters aiming to enter the U.S. market.

In the European Union, lenvatinib received marketing authorization from the European Medicines Agency (EMA) in May 2015 for the treatment of differentiated thyroid carcinoma refractory to radioactive iodine. The United Kingdom, following its departure from the EU, has maintained similar regulatory standards through the Medicines and Healthcare products Regulatory Agency (MHRA).

Compliance with Good Manufacturing Practice (GMP) standards is mandatory for pharmaceutical products in both the EU and UK. Indian exporters must ensure that their manufacturing facilities are GMP-certified to meet these stringent requirements.

As of the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, lenvatinib is not included. (who.int) Consequently, it is not part of the WHO Prequalification Programme. However, lenvatinib must comply with international pharmacopoeia standards, including those set forth by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP).

In India, lenvatinib is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for lenvatinib, allowing market-driven pricing. For export purposes, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations.

Lenvatinib is protected by patents in several jurisdictions, including the United States, where exclusivity extends until February 2036. This patent protection limits the entry of generic versions into the market, thereby affecting the competitive landscape for Indian exporters.

In May 2025, the WHO Expert Committee on Selection and Use of Essential Medicines convened to update the Model List of Essential Medicines. The 24th edition, published in September 2025, did not include lenvatinib, reflecting ongoing evaluations of its global health impact. (who.int)

In April 2025, the WHO launched the National Essential Medicines Lists (nEMLs) repository, a centralized digital platform compiling 150 national essential medicines lists. This resource aims to enhance access to critical healthcare data, supporting policymakers and healthcare professionals worldwide. (who.int)

These developments underscore the dynamic nature of the pharmaceutical regulatory environment and the importance of staying informed about changes that may impact the export and distribution of lenvatinib.

India's pharmaceutical industry heavily relies on China for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs). China controls approximately 70–80% of the global KSM supply and 60–70% of intermediates, making it a dominant player in the sector. This dependency poses significant risks, as any disruption in Chinese supply chains can directly impact India's pharmaceutical production. For instance, in November 2024, India inaugurated two greenfield plants under the Production Linked Incentive (PLI) scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, aiming to reduce import dependence on China.

The reliance on Chinese KSMs is particularly concerning for drugs like Lenvatinib, where the synthesis process depends on these materials. The concentration of KSM production in China means that any geopolitical tensions, trade restrictions, or production issues in China can lead to supply chain disruptions for Indian manufacturers. This structural dependency underscores the need for India to develop domestic capabilities in KSM and API production to ensure a stable supply chain.

The export market for Lenvatinib is notably concentrated, with the top five exporters accounting for 63.0% of the total market share. SUN PHARMACEUTICAL INDUSTRIES LIMITED alone holds a 35.0% share, indicating a significant reliance on a few key suppliers. Such concentration increases the risk of supply chain disruptions if any of these major suppliers face operational challenges.

To mitigate this risk, the Indian government has implemented the PLI scheme to boost domestic production of APIs and KSMs. In October 2024, two plants were inaugurated under this scheme to manufacture essential molecules, aiming to reduce import dependence and diversify the supplier base. However, the effectiveness of these initiatives in reducing supplier concentration remains to be fully realized.

Global shipping routes, such as the Red Sea and the Strait of Hormuz, are critical for the transportation of pharmaceutical products. Geopolitical tensions in these regions can lead to shipping delays and increased costs. Additionally, ongoing US-China trade tensions have the potential to disrupt the supply of KSMs and APIs, further impacting India's pharmaceutical exports.

The FDA has reported that quality issues are a leading cause of drug shortages, accounting for 88% of supply disruptions. While specific shortage alerts for Lenvatinib have not been issued, the industry's reliance on imported KSMs and APIs makes it vulnerable to such disruptions.

• Diversify Supplier Base: Encourage the development of multiple domestic suppliers for KSMs and APIs to reduce reliance on a few key exporters.

• Enhance Domestic Production: Invest in infrastructure and technology to boost local manufacturing capabilities for critical pharmaceutical ingredients.

• Strengthen Quality Control: Implement stringent quality assurance measures to prevent manufacturing issues that could lead to supply disruptions.

• Monitor Geopolitical Developments: Establish a dedicated team to track global political events and assess their potential impact on supply chains.

• Develop Contingency Plans: Create comprehensive strategies to address potential supply chain disruptions, including alternative sourcing and inventory management.

RISK_LEVEL: MEDIUM