Mylan Inc. (MYL - Analyst Report) recently announced that Teva Pharmaceutical Industries Limited’s (TEVA - Analyst Report) lawsuit related to the latter’s Copaxone was dismissed by the US District Court for the Southern District of N.Y. Teva alleged that Mylan's abbreviated new drug application (ANDA) for its generic version of Copaxone infringed four patents (66,514,938, 7,074,580, 7,163,802, and 7,615,359) protecting the drug.
Meanwhile, Mylan is also appealing an unfavorable ruling by the US District Court for the Southern District of N.Y. related to several other Copaxone patents (5,800,808, 5,981,589, 6,048,898, 6,054,430, 6,342,476, 6,362,161, 6, 620,847, 6,939,539 and 7,199,098).
A favorable ruling would enable Mylan to launch its version of generic Copaxone subject to regulatory approval.
We note that Copaxone is approved for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
The drug generated global sales of $1.1 billion in the first quarter of 2013. However, Copaxone revenues are already under pressure given that multiple sclerosis is a heavily crowded market with players like Avonex, Tysabri, Rebif and Gilenya. Additionally, new entrants in the form of Aubagio and Tecfidera can further stiffen competition and eat into Copaxone’s share.
We note that Sandoz, the generic arm of Novartis (NVS - Analyst Report), is also looking to launch its generic version of Copaxone.
Mylan and Teva both carry a Zacks Rank #3 (Hold). Actavis, Inc. (ACT - Analyst Report) appears to be more attractive in the generic space with a Zacks Rank #2 (Buy).