Alembic Pharma gets USFDA nod to market generic antidepressant drug

Alembic Pharmaceuticals on Thursday said it has received an approval from the US health regulator to market a generic antidepressant medication in the American market.

The company has received an approval from the US Food & Drug Administration to market Brexpiprazole tablets in strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the drug firm said in a statement.

The company's product is therapeutically equivalent to Otsuka Pharmaceutical Co's reference listed drug product Rexulti tablets, it added.

Brexpiprazole tablets are indicated as an adjunctive therapy to antidepressants for the treatment of major depressive disorder and for the treatment of schizophrenia.

According to IQVIA data, Brexpiprazole tablets in strenghts of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg have an estimated market size of USD 1.6 billion for 12 months ended December 2022.

The US market is the world's largest for pharmaceutical products.

In 2021-22 fiscal, India's total pharma exports to global markets, including the US, stood at around Rs 1,75,040 crore.

Shares of Alembic pharmaceutical were trading 0.82 per cent down at Rs 508.10 apiece on the BSE.