Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg Tablets: Announces Settlement Agreement with innovator

Generic player Mylan announced that its subsidiary Matrix Laboratories Limited received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Further, Mylan has obtained approval on this important product on on July 20, 2010

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 U.S. beginning in November, 2011 or earlier under certain circumstances. Additional terms of the agreement were not disclosed.

Earlier, innovator has settled the patent litigation with generic player Teva, as reported earlier by this blog http://ippharmdoc.blogspot.com/2009/03/minocycline-hcl-solodyn-innovator.html

Minocycline ER had U.S. sales of approximately $496 million for the 12 months ending March 31, 2010, according to IMS Health.

Source: Mylan Press release http://investor.mylan.com/releasedetail.cfm?ReleaseID=491217