For several years, federal authorities in the U.S. have had a healthy interest in how Irish drugmaker Shire has been handling sales and marketing of its very popular franchise of drugs for attention deficit hyperactivity disorder. The ADHD drugs were in big demand, sometimes in short supply, and until last year, Shire had a stranglehold on all of the generic versions of Adderall XR.
As it turns out, federal authorities were interested in the way Shire ($SHPG) was pushing many of its drugs and the company has now disclosed that an agreement is close. It said it will take a $57.5 million charge to its fourth-quarter earnings to settle up for its missteps.
The settlement covers its onetime blockbuster Adderall XR, but also its newer ADHD drug Vyvanse and its ADHD patch Daytrana. The deal also ropes in marketing of two ulcerative colitis drugs, Lialda and Pentasa, the company acknowledged.
Until June, Shire had tight control over the ADHD franchise. It not only sold the branded version of Adderall XR, but supplied authorized generics to Teva Pharmaceutical Industries ($TEVA) and Impax Laboratories ($IPXL), so it got a significant slice of the revenues from those. The FDA surprised the market last summer when it approved the first third-party rival to Adderall XR, a generic from Actavis ($ACT), that was permitted on the market a full year ahead of what was expected.
Federal authorities have still not piped up about the settlement, and a spokesman declined to comment to The Associated Press, so it is unknown whether the early approval was intended as any kind of penalty for Shire's naughtiness.
- here's the release
- get more from the AP
FDA hits Shire with early nod for Adderall XR copycat
Shire shrugs off blame for Adderall shortage
Shire gets FDA backing on Vyvanse