SK Biopharm "Cenobamate US Patent Extended 5 Years... Until 2032"

New Epilepsy Drug Cenobamate
"Securing Long-Term Growth Potential Through Patent Extension"

SK Biopharm announced on the 10th that the patent term for the epilepsy drug Cenobamate (U.S. product name Xcopri) in the United States has been extended by 5 years until October 30, 2032.

SK Biopharm Cenobamate.
[Photo by SK Biopharm]

Cenobamate obtained its substance patent in October 2007 and received new drug approval in the U.S. in November 2019, officially launching in May 2020.

The substance patent period, originally set to expire in October 2027, has been extended by 5 years to October 2032. SK Biopharm explained that the company was granted the maximum patent term extension of 5 years by the U.S. Food and Drug Administration (FDA) and the U.S. Patent Office in recognition of the long time taken for the development and approval of Cenobamate.

According to SK Biopharm, for new drugs protected by patents in the U.S. market, the extension of the patent period significantly impacts the drug’s value and the company’s profitability. This is because it is common to achieve maximum sales until the patent expires due to increasing prescriptions and drug price hikes each year.

Cenobamate’s U.S. sales in the third quarter of 2023 reached 75.7 billion KRW, an increase of about 19% compared to the previous quarter and about 60% compared to the same period last year. Additionally, it has achieved 14 consecutive quarters of sales growth since its launch in the U.S. market.

In September, the monthly prescription count was 22,985, which is twice the average prescription count at the 41st month after the launch of competing new drugs. Based on the increasing number of new prescriptions expanding since the beginning of this year, the total prescription count (TRx) in the U.S. continues to grow. The company stated, "Cenobamate has entered a stage where annual sales exceeding 300 billion KRW are possible from U.S. sales alone, and it is growing every quarter."

SK Biopharm expects Xcopri to grow into a blockbuster drug generating 1 billion USD in U.S. sales by 2029.

Lee Dong-hoon, CEO of SK Biopharm, said, "We expected the patent extension to be possible, but we are pleased to announce that it has been confirmed with a 5-year extension this time," adding, "This means securing long-term rapid growth until October 2032 amid the recent acceleration of Xcopri’s sales growth."

The CEO continued, "Based on the strong cash-generating power from Xcopri, we will grow into a 'big biotech' expanding into innovative technology platforms."

This content was produced with the assistance of AI translation services.