Alembic Pharmaceuticals Limited has achieved final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Brexpiprazole Tablets.
The approved strengths include 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. These tablets are therapeutically equivalent to Rexulti Tablets, developed by Otsuka Pharmaceutical Company.
Brexpiprazole is an atypical antipsychotic prescribed as an adjunctive therapy for major depressive disorder (MDD) in adults and for the treatment of schizophrenia in adults and pediatric patients aged 13 and older. The estimated market size for Brexpiprazole Tablets is approximately $2.0 billion for the 12 months ending September 2024, according to IQVIA.
Alembic Pharmaceuticals continues to expand its presence in the US market, with a cumulative total of 220 ANDA approvals, including 194 final approvals. This milestone reinforces the company’s commitment to providing affordable, high-quality healthcare solutions.
In the meantime, Alembic Pharmaceuticals’ shares opened today at ₹1,013.90, reaching a high of ₹1,015.55 and a low of ₹988.00. The stock remains significantly below its 52-week high of ₹1,303.90 but above the 52-week low of ₹823.40. As of 12:30 PM, the shares were trading 0.35% lower at Rs 1,006.00.
