Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for aripiprazole tablets USP, 2 mg, 5 mg, 10 mg,15 mg, 20 mg and 30 mg, to market a generic equivalent of Abilify tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, of Otsuka Pharmaceutical Company, Ltd. The product will be manufactured at Lupin’s Pithampur facility in India.
Aripiprazole tablets USP are indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder and treatment of tourette’s disorder.
Aripiprazole tablets USP (Abilify) had estimated annual sales of USD 107 million in the US (IQVIA MAT January 2024).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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