Pharma major, Lupin Ltd., announced today that it has received final approval for its Quetiapine Fumarate Tablets 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg strengths from the U.S. Food and Drug Administration (FDA). Quetiapine Fumarate Tablets is AB rated generic equivalent of AstraZeneca's SEROQUEL® Tablets (25, 50, 100, 200, 300 & 400 mg). Lupin has already launched and commenced shipping the product in the US, the United Kingdom, and Germany day one. Quetiapine is a psychotropic agent, indicated for treatment of Schizophrenia & acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. It is also indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder and for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.
AstraZeneca's SEROQUEL® Tablets had sales of USD 4.6 billion as per IMS Health, December 2011.
Lupin Statement "We expect substantial price erosion due to competition and we are confident that we will garner healthy market share of the product given our track record in the US and European Generics market."
The 5th Largest and the fastest growing US generic player, Lupin continues to maintain its dominance in the U.S. generic market. 16 out of the 32 marketed generic products in the U.S. rank No. 1 by market share and 30 of these 32 are in the Top 3 by Market share (IMS Health – Sep, 2011). Lupin’s prescriptions market share has grown to 5.1% in the generics space in the U.S. (IMS Health).