Boryung's follow-on drug referencing 'Lenvima' to be reimb

Lenvanib Cap 4 mg with new solvate added…priced at 90% of the original drug

Usage patent involving indications no. 3·4 are subjected to usage patent dispute…the future trial outcome gains attention

Product photo of Lenvima

The first follow-on medicines developed by Boryung similar to Lenvima (lenvatinib mesylate) is expected to be added to the reimbursement listing in May.

 

This drug is made by addition of the new dimethyl sulfoxide (DMSO) solvate to the original Lenvima.

 

The drug's supporting document has been submitted and it was approved by the Ministry of Food and Drug Safety (MFDS) in February.

 

The original Lenvima's patent has been expired, but the follow-on patents, including usage patent, are still effective.

 

Lenvima's company is still fighting Boryung regarding this, so future responses from two companies are gaining attention.

 

According to industry sources on April 21, Lenvanib Cap 4 mg (lenvatinib mesylate dimethyl sulfoxide) This drug references Eisai's Lenvima Cap 4 mg (lenvatinib mesylate).

 

Lenvima Cap 4 mg is reimbursed for KRW 29,739.

 

Lenvanib Cap 4 mg was priced at 90% of the original drug because pharmaceuticals that submit supporting documents and are developed by changing salt or as isomer are priced at 90% of the ceiling cap of the targeted product.

 

The MFDS concluded that adding new solvate (dimethyl sulfoxide) can be categorized into new salt, so it approved Lenvanib Cap 4 mg as a pharmaceutical with an active ingredient containing new salt.

 

At the time of obtaining MFDS approval in February, Boryung was approved for Lenvanib Cap 4 mg, Lenvanib Cap 10 mg, and Lenvanib Cap 12 mg.

 

Among these, 12 mg is not available for the original drug.

 

However, only the 4 mg product will likely be added to the reimbursement list in May.

 

The rest of the products will be considered for the reimbursement process later.

 

Lenvanib Cap 4 mg's addition to the reimbursement list was possible because the original product's substance patent expired on the 4th of last month.

 

Boryung continues to challenge other follow-on patents, including usage patent, through patent trials.

 

The final patent dispute outcome is expected to impact Lenvanib sales.

 

The approval indication for Lenvanib Cap 4mg is the same as that of the original Lenvima Cap 4 mg.

 

Both drugs are approved for multiple indications, including 1.

 

the treatment of radioiodine‑refractory, locally recurrent or metastatic progressive differentiated thyroid cancer; 2.

 

first‑line therapy for unresectable hepatocellular carcinoma; 3.

 

in combination with pembrolizumab in patients with advanced endometrial cancer, without the conditions of MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient) mismatch repair–proficient, who have progressed on prior systemic therapy and are ineligible for surgery or radiotherapy; 4.

 

first‑line treatment of advanced renal cell carcinoma.

 

A legal dispute between the companies is anticipated because number 3 and 4 indications are related to usage patents.

 

Lenvatinib mesylate is a tyrosine kinase inhibitor that blocks vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF) receptors to suppress angiogenesis and tumor proliferation.

 

It is currently reimbursed for the treatment of hepatocellular carcinoma and differentiated thyroid cancer.

 

The original Lenvima's sales in 2023 amount to KRW 10.3 billion, based on IQVIA.