(PRNewswire) Mylan N.V. has announced the U.S. launch of its Lidocaine Patch 5%, which is the generic version of Endo Pharmaceutical’s Lidoderm®. 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 relief of pain associated with post-herpetic neuralgia.
Lidocaine Patch 5% had U.S. sales of approximately $1.1 billion for the 12 months ending June 30, 2015, according to IMS Health. Currently, Mylan has 266 ANDAs pending FDA approval representing $100 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.
