Central nervous system (CNS) specialist Lundbeck (LUND: CO) has announced a decision from the Japanese Ministry of Health, Labor and Welfare granting the Danish firm a further two years of market exclusivity on its antidepressant Lexapro (escitalopram oxalate).
Lexapro is currently one of the three most-commonly prescribed antidepressants in the lucrative Japanese market, which had an estimated 2017 value of $1.5 billion. The other two were mirtazapine and duloxetine. Around one million Japanese people suffer from clinical depression, with the number increasing every year.
The extension was granted by the government on the grounds that manufacturers would continue to work on developing Lexapro-based therapies for pediatrics, meeting the unmet need of children afflicted with depression in Japan. It means that Lexapro will be protected from competition until April 2021, a decade after it was approved for use in the Asian country. In November 2015, the treatment received the approval of an additional indication, social anxiety disorder, from the Japanese regulator.
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