Will generic for Nexavar be released?

The attention is focused whether the generic drug of Nexavar (Sorafenib, Bayer) which has an absolute position as the first drug for liver cancer will be available in the market soon or not.

 

Access to the patient is expected to improve further if the generic for Nexavar which has established an almost exclusive position in the liver cancer treatment market is launched.

 

According to the MFDS, as of 29th of last month, a generic company filed an application for permission for generic for Nexavar.

 

According to the patent linkage system, the patent holder Bayer was informed of the application for permission.

 

Currently, Nexavar is registered in the patent list only crystalline form patent until September 20, 2025.

 

Hanmi decided to evade the patent in December 2017 after a lawsuit to the Supreme Court.

 

In addition, Hanmi claimed to be invalid in the formulation patent & the method of use patent that were due to expire on February 22, 2026, and the patent was invalidated after a lawsuit to the Supreme Court.

 

And only the crystalline form patent avoided by Hanmi is effective after the active ingredient patent expires on January 12th.

 

In the meantime, Hanmi has been developing generics through bioequivalence tests.

 

On the 24th, Kwangdong Pharmaceuticals was also approved for the bioequivalence test plan for Nexavar’s generics.

 

It is not known which company applied this time.

 

However, given the recent development history, it is possible that it is Hanmi.

 

If approved, it is expected to raise expectations in the market as the first generic for Nexavar.

 

Nexavar acquired a domestic product license in January 2008, and established an exclusive position in the market until Lenvima (Lenvatinib mesylate) by Eisai Korea was released last year.

 

According to IQVIA, the sales amount was ₩25.4 billion last year.

 

It is noteworthy whether generic will succeed in launching early and threaten the original company’s absolute share.