Zydus receives USFDA approval to market Valbenazine capsules

New Delhi: Ahmedabad based Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, the company said in a statement on 9 August, Friday. Valbenazine, sold under the brand name Ingrezza, is a medication used to treat tardive dyskinesia.

Valbenazine is used for treating tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts). Valbenazine is also used to treat chorea (sudden movements that you cannot control) caused by Huntington's disease (an inherited disease that causes the progressive breakdown of nerve cells in the brain).

The company said in a statement that the drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ - II, India.

"Zydus was one of the first abbreviated new drug applications (ANDA) applicants to submit a substantially complete ANDA with a

paragraph IV certification for Valbenazine Capsules, 40 mg, and 80 mg, and was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 60 mg," it stated in the statement.

With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Valbenazine Capsules, 40 mg, and 80 mg, and is eligible for 180 days of sole generic drug exclusivity for Valbenazine Capsules, 60 mg. Valbenazine Capsules had annual sales of USD 1993.6 million in the United States (IQVIA MAT June 2024).

The group now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.

In the past six months, the company's share price has surged by 61.48 percent, and over the past year, it has risen by 86.51 percent. Zydus Lifesciences is currently selling at an earnings per share (EPS) of ₹34.20, with a price to earnings multiple of 37.41 times.