'Lixiana' patent expires next year, good news for

generic companies

Hanlim Pharm acquired approval of bioequivalence test for its generic…29 items have been approved

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As the patent of 'Lixiana (edoxaban),' a Direct Oral Anti-Coagulant (DOAC), is set to expire, generic companies are entering the competition.

 

On January 21, the Ministry of Food and Drug Satefy (MFDS) approved bioequivalence tests, which are open-label, randomized, two groups, single time-point, cross-over Phase 2 trials involving healthy adult study participants oral administration on an empty stomach, for Hanlim Pharm's 'Edoxaban' and Daiichi Sankyo Korea's 'Lixiana Tab 60 mg.' The Lixiana patents listed in the Ministry of Food and Drug Safety's (MFDS) patent registry are two types: the substance patent, which is set to expire on November 2026, and the composition patent, which is set to expire on August 2028.

 

For the Lixiana composition patent, 10 companies, including Boryung, Dong-A ST, HK inno.N, Samjin Pharm, Shinil Pharma, Chong Kun Dang, Kolmar Pharma, Kolmar Korea, Hutex, and Hanmi Pharmaceutical, have successfully avoided the patent through passive rights scope confirmation trials.

 

Korean companies that won patent avoidance can launch their generics when the substance patent expires in November 2026.

 

To meet this schedule, these companies have been applying for approvals of generic Lixiana and bioequivalent tests since 2023.

 

Dong-A ST was the first to obtain approval for its generic version of Lixiana in 2021.

 

However, despite winning patent avoidance, the company did not meet the requirement for being the first request for trial, so it failed to obtain a right to priority sale.

 

Without a right to priority of sale, 12 companies, including Genuone Sciences, Genu Pharma, Hutex Korea Pharmaceutical, Handok, Shinil Pharma, Ahngook Pharm, Shinpoong Pharm, Nexpharm Korea, Samsung Biologics, Korea Prime Pharm, and Union Korea Pharm, have received approvals for 29 generic products.

 

Additionally, as companies such as CMG Pharmaceutical, Hanlim Pharm, Theragen Etex, and Vivozon conduct bioequivalence tests, competition intensifies in the generic market even before product launches.

 

Lixiana has been ranked top for a long time in the DOAC market, with yearly prescription sales of KRW 100 billion.

 

According to a pharmaceutical market research firm, UBIST, Lixiana's prescript sales for 2023 amounted to KRW 105.3 billion, up 9% from KRW 96.7 billion in 2022.

 

It recorded KRW 55.7 billion in the first half of last year.

 

Lixiana has maintained a leading position in the market since it ranked first in 2019.

 

Analysis suggests that joint sales with Daewoon have contributed positively to the increase in prescription sales.