Alembic Pharmaceuticals gets FDA approval for Lurasidone Hydrochloride Tablets

Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.

Lurasidone Hydrochloride Tablets is a generic version of Latuda Tablets owned by Sunovion Pharmaceuticals, which has approval as monotherapy treatment of adult and pediatric patients (10 to 17 years) who have major depressive episode associated with bipolar I disorder (bipolar depression).

Lurasidone Hydrochloride Tablets also have approval in the US for adjunctive treatment with lithium or valproate in adults having major depressive episode associated with bipolar I disorder.

Alembic Pharmaceuticals gets FDA approval for Lurasidone Hydrochloride Tablets. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

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

Alembic Pharmaceuticals said that it has settled the case with Sunovion Pharmaceuticals and will launch the generic as per the terms of settlement.

The Indian pharma company has a total of 144 ANDA approvals to its credit so far from the FDA, which include 126 final approvals and 18 tentative approvals.