Alembic Pharma gets USFDA Final nod for Lurasidone Hydrochloride Tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg, of Sunovion Pharmaceuticals Inc. (Sunovion).

Lurasidone Hydrochloride Tablets are 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.

Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg have an estimated market size of US$ 3.7 billion for twelve months ending December 2020 according to IQVIA. Alembic 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 USFDA.