Impax Laboratories, Inc. confirmed that the US Food and Drug Administration (FDA) has granted final approval of the company's Abbreviated New Drug Application (ANDA) for generic versions of Solodyn (minocycline HCI) 45mg, 90mg and 135mg extended-release tablets. Medicis markets Solodyn for the treatment of moderate-to-severe acne.
As previously announced on December 1, 2008, Impax and Medicis entered into a Settlement and License Agreement, under which Impax has a license to market its generic versions of Solodyn 45mg, 90mg and 135mg through Global Pharmaceuticals, Impax's generic division, under the Solodyn intellectual property rights belonging to Medicis, no later than November 2011.
Upon launch of its generic formulations of Solodyn, Impax may be required to pay Medicis a royalty, based on sales of those generic formulations by Impax under terms described in the Settlement and License Agreement.
According to Wolters Kluwer Health, US sales of Solodyn were approximately $340 million across all strengths for the 12 month period ending December 2008.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.