Glenmark Pharma hits 52-week high on USFDA approval for Topiramate capsules

Glenmark Pharma informed the exchanges in a filing on July 17 that the company has received Abbreviated New Drug Application (ANDA) approval from the USFDA for Topiramate Capsules USP, 15 mg and 25 mg. Topiramate is used to treat and prevent seizures in epilepsy.

The pharma major said that Glenmark’s Topiramate Capsules USP, 15mg and 25mg, are bioequivalent and therapeutically equivalent to Janssen Pharmaceuticals, Inc’s Topamax Capsules of 15mg and 25mg.

According to IQVIA sales data for the 12-month period ending May 2024, the sales of Topamax Capsules, 15mg and 25mg, in the US market stood at approximately $21.9 million.

The pharmaceutical company mentioned in the release that its current product portfolio consists of 198 products that are authorised for distribution in the US marketplace. Glenmark Pharma also has 50 Abbreviated New Drug Applications (ANDA) pending approval by the US drug regulator.

The pharma company also continues to identify and explore external development partnerships to increase the growth of its existing pipeline and enhance its portfolio.

Last month, on June 12, Glenmark Pharma received final approval from the USFDA for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC). Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg (OTC), will be distributed in the American market by Glenmark Therapeutics Inc, USA. The drug is used for the treatment of erosive esophagitis (EE) in adults and paediatric patients aged 12 to 17 years.

The company said that the USFDA has determined the drug to be bioequivalent to Nexium 24-hour Delayed-Release Capsules, 20 mg (OTC), which are manufactured by Haleon US Holdings LLC.

Shares of Glenmark Pharma gained nearly 1% to an intraday high of ₹1,425 apiece on the NSE. However, the stock pared some gains to trade ₹1,421 apiece, up 0.74%, on the NSE at 1:30 pm.