Indian, Israeli and US drugmakers leap into US market with generic Seroquel
Less than a week after a US District Court for the District of Columbia issued an opinion and order in the law suit against the US Food and Drug Administration regarding final marketing approval of generic quetiapine (The Pharma Letter March 23) three Indian drugmakers, as well as others, have launched copies of the AstraZeneca (LSE: AZN) blockbuster antipsychotic Seroquel.
India drug major Dr Reddy’s Laboratories (NYSE: RDY) yesterday announced that it has launched Quetiapine fumarate tablets (25mg, 50mg, 100mg, 200mg, 300mg and 400mg), a bioequivalent generic version of Seroquel tablets in the US market on March 27, following approval of the copy by the US Food & Drug Administration.
The Seroquel brand had US sales of around $4.6 billion for the most recent 12 months ending December 2011 according to IMS Health data quoted by Dr Reddy’s.
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