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  • Champix patent expires soon, follow-ons eager to launch
  • by Lee, Tak-Sun | translator Byun Kyung A | Nov 18, 2019 10:21pm
Extended patent term to expire next July, heated competition to start then
MFDS approves Yuhan¡¯s follow-on IND Phase 1 clinical trial
Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original.

Seemingly, Yuhan is preparing for the Pfizer¡¯s Champix¡¯s patent to expire in next July.

On Nov. 11, Ministry of Food and Drug Safety (MFDS) approved an investigational new drug application for Phase 1 clinical trial on Yuhan¡¯s candidate medicine, ¡®YHP190¡¯.

The study protocol states it aims to compare and evaluate pharmacokinetics of healthy adult subject arms taking 1mg of YHP1903 and 1mg of Champix tablet, respectively. The commercial clinical trial is to be initiated for the regulators to approve Champix¡¯s follow-on
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