Mumbai-based Glenmark Pharmaceuticals announced on Thursday that it has launched the generic version of Epinephrine injection multiple-dose vial in the US market, which is eligible for 180 days of competitive generic therapy (CGT) exclusivity.
According to a company statement, Glenmark Pharmaceuticals Inc., USA, an arm of the company, has launched the Epinephrine injection of strength 10 mg/10 mL (1 mg/mL) multiple-dose vial.
Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. According to Mayo Clinic, it is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.
Glenmark President & Business Head, North America, Marc Kikuchi mentioned in the statement that the launch of the injection grows the company’s portfolio of products within the institutional channel, while also reinforcing its commitment to providing quality and affordable alternatives for patients.
The company’s Glenmark’s Epinephrine injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial is bioequivalent and therapeutically equivalent to the reference-listed drug of BPI Labs, LLC, according to the company statement.
The injection is used to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock and also for emergency treatment of allergic reactions.
“This launch of Epinephrine injection USP, 10 mg/10 mL (1 mg/mL) multiple-dose vial is eligible for 180 days of CGT exclusivity,” according to the company statement.
The Glenmark statement mentioned that the Epinephrine injection 10 mg/10 mL (1 mg/mL) market achieved annual sales of approximately USD 42.7 million, citing IQVIA sales data for the 12-month period ending December 2024.