BRUSSELS (AP) – European Union antitrust regulators said they are investigating whether drug makers Cephalon and Teva were working to keep a generic version of sleep-disorder drug Provigil out of the European market.

U.S.-based Cephalon Inc. and Israel-based Teva Pharmaceutical Industries Ltd., one of the world’s largest generic drugs maker, in 2005 settled patent disputes relating to Provigil – which is also known as Modafinil – in the U.K. and the U.S.

As part of that deal, Teva agreed not to sell its generic version of Provigil in the EU as well as Iceland, Liechtenstein, and Norway before Oct. 2012, the EU’s competition watchdog said.

The European Commission is now probing whether that agreement broke EU competition rules and had the “object or effect” of keeping generic Provigil out of the European market.

So-called “pay-for-delay” deals between brand-name and generic drug makers have come under scrutiny from competition authorities on both sides of the Atlantic, who fear such agreements hurt consumers who have to pay much higher prices for the brand-name drugs even after patents expire.

The U.S. Federal Trade Association filed a lawsuit against Cephalon in 2008, alleging the company paid off potential competitors to keep a cheaper version Provigil off the market.

Provigil, which treats sleeping disorders such as narcolepsy and obstructive sleep apnoea, generated $1.12 billion in revenue for Cephalon last year.

A Cephalon spokeswoman said the company could not immediately comment on the European investigation.

Date: April 28, 2011
Source: Associated Press