Intuniv Class Action: Anti-Competitive Scheme Cost Consumers Millions

A scheme between a brand-name drug maker and its generic competitor cost consumers millions for the ADHD medication Intuniv, according to a recently filed class action lawsuit.

Plaintiff Carmen Richard of Florida alleges defendants Shire and Actavis conspired to drag out the patent protection period for the ADHD drug Intuniv. She claims that by engaging in sham patent litigation, the two companies extended the patent exclusivity for Intuniv by about two years, preventing generic equivalents from entering the market during that time.

The alleged scheme kept the price of Intuniv artificially high while blocking consumers from access to lower-priced generic alternatives, according to Richard’s Intuniv class action lawsuit. As a result, consumers who bought Intuniv during that time ended up paying hundreds of millions of dollars more than they should have had to, the plaintiff claims.

Intuniv’s active ingredient, guanfacine hydrochloride, has been available since 1986 as a treatment for hypertension under the brand name Tenex. By the time the FDA first approved Intuniv in September 2009 as a treatment for ADHD, Richard says, guanfacine hydrochloride had been off-patent and in the public domain for years.

According to this Intuniv class action lawsuit, Shire held the patent exclusivity rights to Intuniv. Those rights expired in September 2013, Richard says. At that time, other manufacturers should have become able to market generic versions of Intuniv, the class action claims.

The price drop that occurs when a brand-name drug loses its patent protection is enormous, as Richard puts it. Drugs can lose 70 percent of market share within weeks of generic entry, she says. Shire itself reported to the SEC that its market share of Intuniv had dropped to a mere nine percent within six months of generic entry, the class action states.

But Richard claims Shire unlawfully extended its patent protection of Intuniv “by asserting patents of dubious validity and by prosecuting weak patent litigation against its generic rivals.” After that, she claims, Shire entered into reverse payment settlement agreements with Actavis, giving Shire two more years to charge full price for Intuniv.

The profits reaped by Shire and Actavis because of those settlement agreements came at the expense of everyday consumers, who paid more for Intuniv during that time than they would have had to pay if generic equivalents had been available, according to the Intuniv class action lawsuit.

Richard argues these actions by Shire and Actavis constitute an unlawful monopoly and an illegal restraint of trade, in violation of federal and state antitrust laws and state consumer protection laws.

She is proposing to represent a plaintiff Class consisting of all persons who paid some or all of the purchase price for either brand-name or generic Intuniv in the state of Florida between Oct. 5, 2012 and the present.

The plaintiff seeks a damage award including treble, actual and consequential damages, restitution and restitutionary disgorgement, plus court costs and reasonable attorneys’ fees, all with interest.

Richard is represented by Bradley Winston of Winston Law Firm, Allan Kanner, Conlee S. Whiteley, Marshall Perkins and Layne Hilton of Kannner & Whiteley LLC, and Ruben Honik and David J. Stanoch of Golomb & Honik PC.

The Intuniv ADHD Medication Class Action Lawsuit is Carmen Richard v. Shire US Inc., et al., Case No. 1:16-cv-24907, in the U.S. District Court for the Southern District of Florida.