Boryung's application for a generic version of Lenvima has sparked attention as it prepares for upcoming patent litigation against Korea Eisai. According to the Ministry of Food and Drug Safety (MFDS), Boryung applied for marketing authorization for the generic version on August 30th, under the country’s patent linkage system requirements.

Lenvima, a targeted anticancer drug used to treat thyroid and liver cancer, is the sole focus of Boryung's patent challenge in South Korea. The generic version, submitted on August 30th, mirrors the original product in formulation and indications. It is a hard capsule with granules and includes the same four indications: differentiated thyroid cancer, first-line treatment of hepatocellular carcinoma, combination therapy with Keytruda for treatment-resistant endometrial cancer, and advanced renal cell carcinoma, also in combination with Keytruda.

Interestingly, while Korea Eisai’s Lenvima is approved in 8 mg and 10 mg doses, Boryung's application includes 8 mg, 10 mg, and an additional 12 mg dose. This expanded dosage range likely reflects clinical needs, especially for thyroid and liver cancer treatments.

The typical dosage for differentiated thyroid cancer is 24 mg per day, while hepatocellular carcinoma requires 12 mg in adults over 60 kg. Endometrial and renal cell cancers generally require a 20 mg dose. The 12 mg dosage targets liver and thyroid cancer, with 10 mg intended for endometrial and renal cell cancer treatment.

Lenvima is currently reimbursed for thyroid and renal cell cancer treatments, and the addition of the 12 mg dose may cater to market demand. However, Lenvima is still protected by five patents, and Boryung’s ability to launch its generic version depends on the litigation outcome with Korea Eisai.

Boryung has already invalidated the salt/crystalline form and formulation patents but is now contesting the use patent, expiring in June 2028, and the composition patent, expiring in August 2035. A fifth patent, set to expire in 2025, is expected to naturally lapse during the litigation process.

Lenvima has generated over $7.5 million in annual sales since it was added to the reimbursement list in October 2019, solidifying its status as a blockbuster drug. Boryung’s oncology sales have grown from $60 million in 2019 to $163 million in 2023, and a successful launch of the generic Lenvima could further boost revenue.

Additionally, Boryung is challenging patents for Cabometyx, another liver cancer treatment. By securing generics for both Lenvima and Cabometyx, Boryung aims to build a liver cancer treatment portfolio, positioning Lenvima as the first-line treatment and Cabometyx as the second-line therapy.