Xtandi to list tablet form to defend market ahead of patent expiry

Alvogen, Daewon and others expected to launch generics after June patent expiry

Company aims to preemptively seucre tablet market where no generics yet exist

Astellas Korea’s prostate cancer drug Xtandi Tab (enzalutamide) is expected to be listed for reimbursement next month. With 3 months remaining before the drug’s patent expiry, the company appears poised to defend its market share by adding the tablet formulation to its reimbursement lineup.

This move appears to be an effort to secure a foothold in the tablet prescription market, where no generics have yet been approved, in preparation for generic competition following patent expiry.

According to industry sources on the 19th, Astellas will add tablets to Korea’s reimbursement list next month, following the listing of its soft capsule formulation.

Unlike the soft capsules approved in 2013, the tablet formulation was approved in December 2024. This means the tablets are entering the reimbursement list approximately 1 year and 3 months after approval.

In the case of Xtandi soft capsules, multiple generics have already received approval and are awaiting the expiration of the substance patent on June 27.

Alvogen Korea’s Anamide Soft Capsules, Daewon Pharmaceutical’s Enzadex Soft Capsules, Hanall Biopharma’s Enzaloo Soft Capsules, and Menarini Korea’s EnzalX Soft Capsules are expected to be launched.

Generic competition is also expected to intensify for the tablet formulation. Companies including Hanmi, Chong Kun Dang, Alvogen Korea, JW Pharmaceutical, and GL Pharma have won passive scope confirmation trials on Xtandi’s composition patents.

However, since no generics have yet received marketing approval, entry into the tablet market is expected to lag behind capsules.

The newly listed Xtandi Tab will be available in 40 mg and 80 mg strengths, expanding the reimbursement lineup at the same price level as the capsule formulation.

According to the market research institution UBIST, Xtandi recorded KRW 38 billion in sales last year, up 26% from KRW 30.2 billion the previous year.

However, it appears difficult to sustain this sales growth trend starting in the second half of this year due to the market penetration of generics.