Alembic Pharma gets USFDA nod on lurasidone hydrochloride tablets

The drug maker has received final approval from the US drug regulator for its abbreviated new drug application for lurasidone hydrochloride tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed drug product (RLD), Latuda tablets of Sunovion Pharmaceuticals Inc.

The drug is indicated for monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression). Lurasidone hydrochloride tablets are also indicated for adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder.

As per IQVIA, lurasidone hydrochloride tablets have an estimated market size of $3.7 billion for twelve months ending December 2020. Alembic Pharmaceuticals has settled the case with Sunovion and will launch its generic as per the terms of settlement.

Alembic has a cumulative total of 144 ANDA approvals (126 final approvals and 18 tentative approvals) from United States Food & Drug Administration (USFDA).

Alembic Pharmaceuticals' consolidated net profit jumped 12% to Rs 251 crore on 6% increase in net sales to Rs 1,280 crore in Q4 FY21 over Q4 FY20.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

Shares of Alembic Pharmaceuticals slipped 0.48% to Rs 946.30 on BSE. The stock traded in the range of Rs 940.85 to Rs 961.15 so far.

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