There is on-going development of generic EU CTD Dossier of Olanzapine, mouth dissolving tablets, 5/10/15/20 mg.
Development of this pharmaceutical is carried out according to EU-requirements in country without patent protection or with Bolar-provisions. There will be no sales in those countries where this offer would constitute an infringement of third parties intellectual proprietary rights.
Olanzapine is a selective monoaminergic antagonist with high affinity binding to the following receptors: serotonin 5HT2A/2C (Ki=4 and 11 nM, respectively), dopamine D1-4 (Ki=11-31 nM), muscarinic M1-5 (Ki=1.9-25 nM), histamine H1 (Ki=7 nM), and adrenergic a1 receptors (Ki=19 nM). Olanzapine binds weakly to GABAA, BZD, and b adrenergic receptors (Ki>10 mM).
The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic episodes associated with BipolarI Disorder is unknown.
Antagonism at receptors other than dopamine and 5HT2 with similar receptor affinities may explain some of the other therapeutic and side effects of olanzapine. Olanzapine’s antagonism of muscarinic M1-5 receptors may explain its anticholinergic effects. Olanzapine’s antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Olanzapine’s antagonism of adrenergic a1 receptors may explain the orthostatic hypotension observed with this drug.
More details http://www.rxlist.com/cgi/generic/olanzapine.htm
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