On Wednesday, Lupin Limited, an Indian multinational pharmaceutical company, said it has received a tentative nod from the Food and Drug Administration (FDA) to market generic brexpiprazole in the U.S. market.
Sold under the brand name Rexulti, brexpiprazole is used for the treatment of certain mental or mood disorders, such as depression and schizophrenia. It is a psychiatric medication belonging to the class of drugs called atypical antipsychotics.
Brexpiprazole has been found to improve mood, sleep, appetite, and energy levels. It works by restoring the balance of certain neurotransmitters or brain chemicals.
Lupin, one of the world’s largest generic pharmaceutical companies, said in a regulatory filing, “The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market generic brexpiprazole tablets in the strengths of 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.”
The FDA approved Rexulti in July 2015, which is developed by Otsuka Pharmaceutical India Private Limited (OPI), a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan, and Mitsui & Co. Ltd., Japan.
Lupin said, “The product is a generic version of Otsuka Pharmaceutical Co Ltd’s Rexulti tablets in the same strengths.”
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Generic brexpiprazole tablets will be manufactured at the company’s facility in Madhya Pradesh, India, according to Lupin.
The drug is also indicated for use as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) and schizophrenia. In the United States, the brexpiprazole market had estimated annual sales of $1,258 million, according to IQVIA MAT July 2021 data.
