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Lixiana latecomers apply for approval as an ODT

By Lee, Tak-Sun | translator Alice Kang

21.11.21 15:40:51

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Applied after the PMS period expired on August 25th¡¦was able to avoid the composition patent but will have to be released in 2026



Latecomers of Daiichi Sankyo¡¯s novel oral anti-coagulant (NOAC) ¡®Lixiana (edoxaban tosylate hydrate)¡¯ were found to have applied for approval to the Ministry of Food and Drug Safety.

Although Lixiana¡¯s substance patent does not expire until November 10th, 2026, with the PMS (post-marketing surveillance on new drugs) period expiring on August 24th, the companies have immediately applied for the approval of their latecomers. One characteristic of the latecomer drugs is that they are orally disintegrated tablets (ODT) that dissolve or disintegrate in the tongue without water.

According to the MFDS on the 21st, other edoxaban tosylate hydrate products that contain the same ingredient as

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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