Mylan N.V. on Wednesday announced the U.S. launch of Esomeprazole Magnesium Delayed-release Capsules USP, in 20 mg and 40 mg, which are the generic version of AstraZeneca's Nexium.
Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the product. Esomeprazole Magnesium Delayed-release Capsules USP is indicated for the treatment of gastroesophageal reflux disease in adults and children ages one and older.
"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,” Mylan CEO Heather Bresch said. “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 had U.S. sales of approximately $5.2 billion for the 12 months ending on June 30, according to IMS Health.
Mylan currently 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 Dec. 31, 2014, according to IMS Health.