Zydus Lifesciences bags FDA approval for Cariprazine generic

Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary — Zydus Pharmaceuticals (USA) has secured final approval from the US Food and Drug Administration (FDA) for Cariprazine Capsules, USP 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

In December 2021, Zydus Lifesciences was given tentative approval from the FDA for the drug product.

The Cariprazine Capsules product from the Indian pharma company is a generic of VRAYLAR (Cariprazine), which is an atypical antipsychotic approved for schizophrenia treatment as well as for the acute treatment of manic or mixed episodes resulting from bipolar I disorder.

Zydus Lifesciences said that its subsidiary was one of the first applicants for abbreviated new drug application (ANDA) to file a substantially complete ANDA with a paragraph IV certification for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg. Due to this, the company is eligible for 180 days of shared generic drug exclusivity for Cariprazine Capsules, 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

Zydus Lifesciences bags FDA approval for Cariprazine generic. Photo courtesy of Zydus Cadila.

The schizophrenia drug will be manufactured at its formulation manufacturing plant in Ahmedabad, said Zydus Lifesciences.

According to IQVIA MAT July 2022, the annual sales of Cariprazine Capsules were $2.39bn in the US.

As of 30 June 2022, Zydus Lifesciences has 322 approvals and filed more than 428 ANDAs since the start of the filing process in FY 2003-04.