Global pharmaceutical company Mylan N.V. (NASDAQ : MYL ) today announced the U.S. launch of Esmolol Hydrochloride in Sodium Chloride Injection, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2,000 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, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2,000 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 U.S. 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, 2,500 mg/250 mL (10 mg/mL) Single-Dose Plastic Bag and 2,000 mg/100 mL (20 mg/mL) Single-Dose Plastic Bag were approximately $126 million for the 12 months ending June 30, 2018, according to IQVIA.
Currently, Mylan has 189 ANDAs pending FDA approval representing approximately $91.5 billion in annual brand sales, according to IQVIA. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $50.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.
