Current Lawsuits

Provigil

About Provigil

Provigil is manufactured by Cephalon, Inc. It is marketed as a “wakefulness promoting agent” and is approved to treat certain sleep disorders including narcolepsy and shift work sleep disorder.  It is widely prescribed, however, for unapproved uses such as to treat fatigue, depression, attention deficit hyperactivity disorder, and sleepiness caused by other prescription medications.  Provigil sales were $500 million in 2005.

Background

Provigil was approved by the Food and Drug Administration (FDA) on December 24, 1998 and was granted five years of exclusive marketing rights, an exclusivity which expired on December 24, 2003.  Because the active ingredient in Provigil was used to treat a rare disorder, narcolepsy, Cephalon received an additional “Orphan Drug” exclusivity, which expired on December 24, 2005. 

Anticipating the expiration of the exclusivities, generic drug manufacturers Mylan, Teva, Barr, and Ranbaxy all developed generic versions of Provigil and filed applications with the FDA to manufacture and market the drug.  Each of the generic companies filed their application on December 24, 2002, the first day that such applications could be filed under the Hatch-Waxman Act.  The FDA ultimately granted “tentative approval” to each of the generic versions of Provigil, meaning that the FDA deemed them to be safe, effective and bioequivalent to Provigil.

The generic companies did not receive final approval because on March 28, 2003, Cephalon filed patent infringement lawsuits against each of the generic companies.  While these lawsuits were pending, the generic companies presented strong evidence that cast serious doubt on the enforceability of Cephalon’s patent, the validity of the patent’s claims, and the strength of Cephalon’s infringement theory.  For example, the generic companies claimed that Cephalon’s submission to the patent office contained many intentional misrepresentations.  Despite the strength of their arguments, in late 2005 and early 2006, 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.  The settlement agreements also provided the generic companies with cash payments, supposedly in exchange for certain licensing and supply/inventory agreements.  The three payments to Teva, Ranbaxy and Barr alone totaled up to $136 million.

PAL Member Litigation

In October 2006, PAL members joined a lawsuit against Cephalon, Teva, Ranbaxy, Barr and Mylan. The lawsuit claims that the companies illegally conspired to keep generic versions of Provigil off the market, depriving class members the opportunity to purchase a lower priced generic.

Update September 2008:

The Court has been considering defendant's motion to dismiss since November 3, 2006. A recently filed suit by the FTC against defendant Cephalon Corp. for the same conduct was transferred to the court (E.D. Pa.) on April 28, 2008, to be handled along with this anti-trust case.

Update July 2009:

In April 2009, a new judge was assigned to the case.  Unfortunately for consumers desperate to obtain Provigil at a lower cost, the proceedings have continued to move slowly.  Parties filed notices with the court in June and July 2009 regarding a recent amicus brief filed by the Department of Justice in the Cipro case that may provide authority on the pending motions to dismiss.

Court: U.S. District Court for the District of Pennsylvania.

Provigil Plaintiff Class

Eligible class members for the Provigil lawsuit include all persons and third-party payors who paid some or all of the purchase price for Provigil from December 23, 2003 to present.

Resources:

• Provigil Complaint

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