Takeda Settles "Pay-for-Delay" Consumer Claims for $1.85 Million

Takeda_Tomohiro Ohsumi/Getty Images

Tomohiro Ohsumi/Getty Images

Tokyo-based Takeda Pharmaceutical has agreed to pay $1.85 million as a settlement with consumers who filed a lawsuit against the company for allegedly delaying the commercial release of a generic, cheaper version of its ADHD drug. 

Speaking to reporters, Kanner & Whiteley lawyer Conlee Whiteley, who represented the plaintiffs, said that her clients had accepted the settlement and were "pleased" with the outcome. Takeda lawyer Joshua Barlow of Haug Partners was not available for comment at the time of publication.

The settlement is a huge development for the class action lawsuit against Takeda, which has been going on since 2016. Back then, the consumers, also called indirect purchasers, alleged that brand-name drug manufacturers deliberately dropped patent claims against generic makers and then pay the latter to delay the launch of products that compete with theirs. 

In this specific case, Actavis reportedly delayed the release of the generic version of ADHD drug Intuniv. Before news of the latest settlement agreement, indirect purchasers had already signed into a $1.1 million settlement offer from Teva Pharmaceutical Industries, which took over ownership of Actavis in 2015. 

This is not the first time that settlements have been agreed on in relation to generic Intuniv. Direct purchasers, or those who have purchased the drug directly from either Actavis or Takeda's predecessor Shire PLC, had already received $20 million in settlement from Teva. Takeda bought the Shire in 2019 and is still facing several claims regarding such "pay-for-delay" schemes. 

The attorney for the direct purchasers, Lauren Barnes of Hagens Berman Sobol Shapiro, also wasn't available for comment at the time of publication. 

Intuniv is a selective alpha-2A adrenergic receptor agonist that's been found to produce positive outcomes for patients diagnosed with attention deficit hyperactivity disorder (ADHD). It contains the active substance guanfacine. Intuniv is a once-daily non-stimulant indicated for children and adolescents ages six to 17 years old. The drug's efficacy in kids under six years and adults over 18 years has yet to be established. 

Prior to its approval for distribution, Intuniv was tested in an extensive clinical study involving 254 patients in Japan. In the trial, the drug was given once a day to one group of patients while the other was given a placebo. Those who were taking Intuniv showed significant improvements based on the ADHD-RS-IV scoring system in all four symptoms of the condition: hyperactivity, impulsivity, and inattention. The most common side effects were somnolence in 57.5% of the participants, headache in 12.2%, and decreased blood pressure in 15.4%.

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