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First generic version of Omacor approved
by Eui Kyoung Yoon (ekyeun@dreamdrug.com)
Published : Dec 31, 2014 15:17:11
The Ministry of Food and Drug Safety approved Youngjin’s Omaron, the first generic version of Omacor on December 31.

Omacor went off patent in June 2013, but no generic version was available because a clinical trial seemed to work better than bioequivalence testing.

Last year about ten pharmaceutical companies started collaborating to develop the generic version of Omacor with a clinical trial while Youngjin and Yuyu partnered to conduct their bioequivalence test.

Finally Youngjin and Yuyu proved the bioequivalence of their generic version. Yuyu is likely to get its marketing approval sooner or later. Hanmi is also working on bioequivalence testing.

Kunil is currently developing a combination drug of Omacor and atorvastatin to defend its market share of Omacor.
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