Mylan Launches Generic Version of Lidoderm® Patch

Aug 10, 2015, 07:30 ET from Mylan N.V.

HERTFORDSHIRE, England and PITTSBURGH, Aug. 10, 2015 /PRNewswire/ -- 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.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products and the company's strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company's business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; uncertainties and matters beyond the control of management; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.

SOURCE Mylan N.V.



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