Mylan/Matrix launch generic Solodyn in USA; settlement with Medicis

Matrix Laboratories, a unit of US generics major Mylan, has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for minocycline hydrochloride extended release tablets, 45mg, 90mg and 135mg, the generic version of Solodyn ER, a treatment for acne, sold by Medicis Pharmaceuticals. Group company Mylan Pharmaceuticals commenced immediate shipment of the product after approval.

Mylan also announced that it reached settlement and license agreements with Medicis resolving patent litigation relating to Minocycline ER, and the company has ceased additional distribution. Pursuant to the terms of the agreements, Medicis will release Mylan from any liability related to the prior sales of this product, and Mylan will have the right to market Minocycline ER in the USA beginning in November 2011 or earlier under certain circumstances. Additional terms of the agreement were not disclosed.

Minocycline ER had US sales of around $496 million for the 12 months ending March 31, 2010, according to IMS Health. Currently, Mylan has 131 ANDAs pending FDA approval representing $92.1 billion in annual brand sales, according to IMS Health. 41 of these pending ANDAs are potential first-to-file opportunities, representing $21.4 billion in annual brand sales, for the 12 months ending December 31, 2009, based on IMS Health data.