Mylan N.V. (Nasdaq: MYL) today 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.
Mylan CEO Heather Bresch said: "We are very pleased to launch our Lidocaine Patch 5%. Mylan's presentation of this product comes in the form of a thin, lightweight patch, and offers patients a high quality, affordable treatment option within the pain management space. We look forward to continue innovating to meet unmet needs as we deliver on our promise to bring complex, difficult-to-manufacture products to market to benefit patients, providers and payors in the U.S. and around the world."
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.