Pharma major Lupin has announced that it has received approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg is the generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
It is indicated for treatment of adult patients with schizophrenia, monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder (bipolar depression), adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).
Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg had annual sales of approximately USD 3217.3 million in the US (IQVIA MAT September 2018).
For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.
