How India Exports Cabozantinib to the World

As of March 2026, the U.S. Food and Drug Administration (FDA) has not approved any Abbreviated New Drug Applications (ANDAs) for generic versions of cabozantinib. The brand-name product, Cabometyx, received its initial FDA approval on April 25, 2016, for the treatment of advanced renal cell carcinoma. Subsequent approvals expanded its indications to include hepatocellular carcinoma. The absence of generic approvals indicates that cabozantinib remains under patent protection, limiting generic competition in the U.S. market.

Despite the lack of generic alternatives, cabozantinib is exported from India to the United States, accounting for 9.2% of total exports. This suggests a demand for the drug in the U.S. market, potentially for clinical trials, compassionate use, or other specialized programs. The presence of 66 active Indian exporters underscores the competitive landscape and the strategic positioning of Indian pharmaceutical companies in supplying cabozantinib to the U.S.

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for cabozantinib in its capsule formulation under the brand name Cometriq in 2014 for the treatment of medullary thyroid cancer. The tablet formulation, Cabometyx, received approval in September 2016 for advanced renal cell carcinoma. The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has aligned with the EMA's decisions, ensuring continuity in the availability of cabozantinib post-Brexit.

Compliance with EU Good Manufacturing Practice (GMP) standards is mandatory for manufacturers exporting cabozantinib to the EU and UK. This includes adherence to stringent quality control measures, regular inspections, and validation processes to ensure product safety and efficacy.

As of the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, cabozantinib is not included. The WHO Model List serves as a guide for countries to develop their national essential medicines lists, focusing on medicines that address priority health needs. The exclusion of cabozantinib may reflect considerations such as cost-effectiveness, availability of alternative treatments, or specific public health priorities.

Regarding pharmacopoeial standards, cabozantinib's monographs are included in major compendia such as the United States Pharmacopeia (USP) and the British Pharmacopoeia (BP), ensuring standardized quality specifications for the drug.

In India, cabozantinib is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription-only medication. This classification mandates that cabozantinib can only be sold by retail on the prescription of a registered medical practitioner.

The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for cabozantinib as of March 2026, allowing market-driven pricing mechanisms to prevail. For export purposes, Indian pharmaceutical companies must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with regulatory requirements and monitoring of pharmaceutical exports.

Cabozantinib is protected by multiple patents, with the primary composition of matter patent set to expire in 2030. This patent protection has delayed the entry of generic versions into the market. However, in May 2024, Exelixis, the manufacturer of Cabometyx, reached a settlement agreement with Cipla Limited and Cipla USA, allowing Cipla to market a generic version of cabozantinib in the U.S. starting January 1, 2031. This settlement indicates a forthcoming increase in generic competition post-patent expiration.

In May 2024, Exelixis announced a settlement with Cipla Limited and Cipla USA regarding patent litigation over Cabometyx. This agreement permits Cipla to launch a generic version of cabozantinib in the U.S. market beginning January 1, 2031, following the expiration of the primary patent.

In April 2025, the World Health Organization (WHO) unveiled a global repository for National Essential Medicines Lists (nEMLs), compiling 150 national lists from six global regions. This initiative aims to enhance access to critical healthcare data, supporting policymakers and healthcare professionals in decision-making processes. (who.int)

In September 2025, the WHO published the 24th edition of its Model List of Essential Medicines, which did not include cabozantinib. The exclusion may reflect considerations such as cost-effectiveness, availability of alternative treatments, or specific public health priorities. (who.int)

In February 2026, the FDA updated its list of approved drugs, confirming that no generic versions of cabozantinib have been approved to date. This underscores the ongoing patent protection and the absence of generic competition in the U.S. market.

In March 2026, the Indian pharmaceutical export data indicated that cabozantinib exports totaled $0.1 million USD, with 302 shipment records and 66 active exporters. The primary destinations included Turkey (13.4%), United Arab Emirates (11.4%), Laos (10.4%), United States (9.2%), and Egypt (7.8%). The average Free on Board (FOB) unit price was $57.06, reflecting the competitive pricing strategies of Indian exporters.

These developments highlight the dynamic regulatory and market landscape for cabozantinib, influenced by patent protections, international regulatory decisions, and global health priorities.

The production of cabozantinib's active pharmaceutical ingredient (API) is predominantly concentrated in India and China. India, despite being a major API producer, relies heavily on China for key starting materials (KSMs) essential for synthesizing APIs. This dependency poses a significant risk, as any disruption in China's supply chain can adversely affect API availability. For instance, during the COVID-19 pandemic in early 2020, lockdowns in China led to substantial delays in the shipment of oncology drug intermediates, causing downstream manufacturers to ration inventories.

Furthermore, a 2025 study highlighted that 41% of key drug ingredients used in U.S.-approved medicines are sourced solely from China, underscoring the global reliance on Chinese suppliers. This concentration introduces vulnerabilities, as geopolitical tensions or export restrictions could disrupt the supply chain, impacting the production of essential medications like cabozantinib.

According to TransData Nexus's proprietary trade data from 2022 to 2026, cabozantinib exports from India amounted to $0.1 million USD, with 302 shipment records involving 66 active Indian exporters. The top five exporters accounted for 34.0% of the total export value, with ROYAL MEDICAL PRIVATE LIMITED leading at a 9.4% share. This moderate supplier concentration indicates a relatively diversified export base, which can mitigate risks associated with over-reliance on a single supplier.

The Indian government's Production-Linked Incentive (PLI) scheme, launched in 2021, aims to bolster domestic manufacturing of pharmaceuticals and reduce dependency on imports. By December 2025, the government had disbursed ₹28,748 crore under 14 PLI schemes, including those for the pharmaceutical sector. This initiative is expected to enhance the capacity and reliability of Indian API manufacturers, thereby strengthening the supply chain for drugs like cabozantinib.

Geopolitical tensions and shipping disruptions pose significant risks to the global pharmaceutical supply chain. The Red Sea and the Strait of Hormuz are critical maritime routes for shipping APIs and finished pharmaceutical products. Any instability in these regions can lead to delays and increased shipping costs. Additionally, escalating U.S.-China tensions have raised concerns about potential export restrictions on essential drug components. A 2025 study warned that China's dominance in supplying key drug ingredients could be leveraged in geopolitical conflicts, threatening global health security.

Regulatory agencies like the FDA and EMA have issued shortage alerts for various medications due to supply chain disruptions. While specific alerts for cabozantinib have not been reported, the interconnected nature of pharmaceutical supply chains means that disruptions in one area can have cascading effects, potentially impacting the availability of critical drugs.

• Diversify Sourcing of KSMs and APIs: Encourage Indian manufacturers to develop alternative sources for KSMs and APIs to reduce dependency on Chinese suppliers.

• Strengthen Domestic Manufacturing: Leverage the PLI scheme to enhance domestic production capabilities, ensuring a more resilient supply chain for cabozantinib.

• Monitor Geopolitical Developments: Establish a dedicated task force to assess and respond to geopolitical risks that could impact the pharmaceutical supply chain.

• Enhance Inventory Management: Implement robust inventory strategies to buffer against potential supply disruptions, ensuring continuous availability of cabozantinib.

• Foster International Collaboration: Engage with global regulatory bodies and industry partners to develop coordinated responses to supply chain challenges.

RISK_LEVEL: MEDIUM