The newly-launched acetylcysteine injection is expected to deliver the same therapeutic effects as the branded drug product, acetadote injection, 6 gm/30 mL (200 mg/mL) single-dose vials, which is manufactured by Cumberland Pharmaceuticals Inc, Glenmark informed the stock exchanges.
Acetylcysteine is commonly used as a therapeutic agent for the treatment of acetaminophen overdose and as a mucolytic agent in the management of respiratory conditions.The US Food and Drug Administration (FDA) approved Glenmark’s version, relying on the safety and effectiveness data from the acetadote injection.
Glenmark acquired the Abbreviated New Drug Application (ANDA) for Acetylcysteine injection, 6 gm/30 mL (200 mg/mL) single-dose Vials from Aspen Pharma USA Inc.With the acquisition, the company aims to provide an affordable and effective alternative to the current product available in the market.
According to IQVIA sales data for the 12-month period ending January 2025, Acetadote injection generated annual sales of approximately USD 15.2 million in the US market.
“We are excited to announce the acquisition and launch of Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials. This is a great addition to our injectable portfolio in the U.S. market as we continue to drive growth for the hospital segment,” Marc Kikuchi, President and Business Head for North America at Glenmark, said.
Shares of Glenmark were trading 0.61% higher at ₹1,286.55 apiece on the BSE at 10:11 am.
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