Help Challenge Drug Industry Attempts to Keep Generics off the Market

Over the next few years, the patents on $100 billion worth of brand-name prescription drugs are set to expire. This unprecedented wave of patent expiration could mean an explosion in the availability of cheaper generic drugs for consumers across the country. That is, unless the drug industry continues to invent new ways to delay bringing these drugs to market.

As we keep our eyes out for the new tactics, we're continuing to challenge some of the older ploys like a brand-name company paying a generic drug company to delay introducing its product. For instance, we are currently planning to join a case over Provigil, a drug commonly used to treat conditions such as narcolepsy, fatigue, depression and attention deficit hyperactivity disorder. Provigil sales were $500 million in 2005.

The case, which was filed in June 2006, claims that Cephalon, the brand name manufacturer of Provigil, conspired with generic drugmakers Teva, Ranbaxy, Barr and Mylan to keep generic versions of Provigil off the market. The case alleges that when Cephalon's exclusive marketing rights were set to expire, the generic companies applied for FDA approval to market generic versions of the drug. Although the FDA determined that each company had developed safe, effective and bioequivalent generic versions of Provigil, they could not begin marketing the drugs because Cephalon filed patent infringement lawsuits against them.

Although they had strong arguments for invalidating Cephalon's patent for Provigil, all four generic companies settled their cases with Cephalon. Under these settlement agreements, each generic company agreed to keep their generic versions of Provigil off the market until 2011 or 2012, in exchange for cash payments. The three payments to Teva, Ranbaxy and Barr alone totaled up to $136 million.

By agreeing to delay bringing a generic version of Provigil to market, the companies forced consumers to buy the more expensive brand-name version of the drug. PAL's goal is to get reimbursement for those consumers and third party payors (i.e. health plans, health funds etc.) and to continue to send the message to the drug companies that these types of agreements are illegal.

PAL is currently adding new plaintiffs to the case. Since December 2003, if you purchased Provigil-paying all or part of the cost-please contact PAL Associate Director, Renée Markus Hodin at (617) 275-2810 or hodin@communitycatalyst.org.