Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg and 40 mg, which is the generic version of AstraZeneca's Nexium®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of gastroesophageal reflux disease (GERD) in adults and children ages 1 and older.
Mylan CEO Heather Bresch commented: "Mylan's launch of Esomeprazole Magnesium Delayed-release Capsules USP represents our continued commitment to expand access to high quality medicine, and we're pleased to provide patients with another affordable treatment option. We look forward to continue delivering on our mission to set new standards in healthcare by expanding our broad portfolio of products in the U.S. and around the world."
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, had U.S. sales of approximately $5.2 billion for the 12 months ending June 30, 2015, according to IMS Health.
Currently, Mylan has 268 ANDAs pending FDA approval representing $101.3 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.