Glenmark Pharmaceuticals acquires and launches acetylcysteine injection

Glenmark Pharmaceuticals USA announces the acquisition and launch of Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) single-dose vials.

Glenmark’s Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) single-dose vials can be expected to have the same therapeutic effect as the listed drug product upon which the agency relied as the basis of safety and effectiveness, Acetadote Injection, 6 gm/30 mL (200 mg/mL) single-dose vials of Cumberland Pharmaceuticals.

Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA.

According to IQVIA sales data for the 12-month period ending January 2025, the Acetadote Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials market achieved annual sales of approximately $15.2 million.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, “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 US market as we continue to drive growth for the hospital segment.”