Mylan settles Provigil litigation with Teva

US generic major Mylan (Nasdaq: MYL) says that its subsidiary Mylan Pharmaceuticals has resolved all disputes with Teva Pharmaceuticals USA, stemming from litigation brought by Mylan in federal court in the District of Columbia against the US Food and Drug Administration concerning Mylan's Abbreviated New Drug Application for modafinil tablets, 100mg and 200mg.

Modafinil is the generic version of Cephalon's Provigil from Cephalon, a US biotech firm acquired by Teva Pharmaceutical Industries (Nasdaq: TEVA), indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work disorder.

A couple of months ago the FDA has decided that Teva Pharmaceuticals USA is sole first-to-file for both Orange Book patents listed for Provigil and therefore Teva’s ANDA alone is entitled to 180-day exclusivity (The Pharma Letter April 9). Cephalon launched generic Provigil on March 29 and the FDA has also decided that such launch triggered the exclusivity. The FTC required Teva to sell the rights and assets related to a generic cancer pain drug and a generic muscle relaxant, as a condition of its $6.8 billion acquisition of Cephalon (TPL October 14, 2011).