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PITTSBURGH — Mylan N.V. announced the U.S. launch of mesalamine delayed-release tablets USP, 1.2 g, a generic version of Shire’s Lialda Delayed-Release Tablets. Mylan Pharmaceuticals 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 induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.
U.S. sales for mesalamine Delayed-Release Tablets USP, 1.2 g, were approximately $842 million for the 12 months ending October 31, 2018, according to IQVIA.
Currently, Mylan has 168 ANDAs pending FDA approval representing approximately $85.5 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $50.4 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.
