Mylan announces launch of Mycophenolic Acid Delayed-release Tablets

Jan 9 2014

Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic^® Delayed-release Tablets. Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for Mycophenolic Acid Delayed-release Tablets, 360 mg, and was awarded 180 days of marketing exclusivity for this strength. The company received final approval from the U.S. Food and Drug Administration (FDA) for its ANDA for this product.

Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg, had U.S. sales of approximately $306.8 million for the 12 months ending Sept. 30, 2013, according to IMS Health. Mycophenolic Acid Delayed-release Tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.(1)

Currently, Mylan has 187 ANDAs pending FDA approval representing $93.7 billion in annual sales, according to IMS Health. Forty of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2013, according to IMS Health. When including ANDAs associated with Mylan's recent acquisition of Agila, the company now has a total of 287 ANDAs pending FDA approval.