Mylan Adds to Cardiovascular Portfolio with Launch of First Generic of Brevibloc Injection

Global pharmaceutical company Mylan N.V. announced the US launch of Esmolol Hydrochloride in Sodium Chloride Injection, 2500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag, the first generic version of the reference listed drug, Baxter’s Brevibloc. Mylan is offering Esmolol Hydrochloride in Sodium Chloride Injection, 2500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag to its institutional customers after an Abbreviated New Drug Application (ANDA) for the product was approved by the US Food and Drug Administration (FDA). Esmolol Hydrochloride in Sodium Chloride Injection is indicated for the short-term treatment of control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia and control of perioperative tachycardia and hypertension.

U.S. sales for Esmolol Hydrochloride in Sodium Chloride Injection, 2500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag were approximately USD 126 million for the 12 months ending June 30, 2018, according to IQVIA. Currently, Mylan has 189 ANDAs pending FDA approval representing approximately USD 91.5 billion in annual brand sales, according to IQVIA. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing USD 50.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA. – Medical Buyer Bureau