FDA Approves First Generic Versions of Strattera
The nonstimulant atomoxetine soon will be available in generic form, which may lower treatment costs by 80 to 85 percent for the children and adults who rely on this commonly used ADHD medication.
May 31, 2017
The FDA has approved the first generic version of Strattera, opening up a new nonstimulant treatment option for children and adults with ADHD.
Strattera is the brand name for atomoxetine, a selective norepinephrine reuptake inhibitor that was one of the first nonstimulant medications available for the treatment of ADHD. Since the drug’s patent expired in May, four companies — Apotex Inc., Teva Pharmaceuticals USA Inc., Aurobindo Pharma Limited, and Glenmark Pharmaceuticals Limited — have unveiled generic versions of the drug. All four were approved on May 30; it’s unclear when the generics will be made available to consumers.
“Today’s approvals mark an important step forward in bringing consumers additional treatments that have met the FDA’s rigorous standards,” said Kathleen Uhl, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, in a May 30 press release. “Quickly bringing generics to market so patients have more options to treat their conditions is a top priority for the FDA.”
Like Strattera, the generic forms of atomoxetine will come with a “black box warning” regarding the medication’s increased risk of suicidal thoughts, particularly for teenagers and young adults. Side effects of the generic versions during the clinical trials were similar to those most often seen with Strattera, like “upset stomach, decreased appetite, nausea or vomiting, dizziness, tiredness, and mood swings,” according to the FDA.
Strattera was first patented by Eli Lilly in 2002, and has dominated the nonstimulant market since. The new generics — which will likely be sold at a significantly lower cost — are expected to lower Lilly’s annual sales of Strattera from $535 million annually to just $13 million by 2022, according to estimates by the life sciences consulting firm Evaluate. Most generic medications are typically priced 80 to 85 percent lower than the originals — meaning ADHD patients who rely on Strattera may see dramatic decreases in their treatment costs once the medications are made available to consumers.