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Sandoz Shire Pharmaceuticals announced that it would allow Sandoz to market a generic version of its blockbuster ADHD med Adderall XR if it can clear FDA. But that's a big if.
Shire, on Tuesday, publically stated that it had come to an agreement with Sandoz to forgo any litigation involving Adderall XR. In exchange, Sandoz admitted it had infringed on two Shire patents.
The settlement also gives Sandoz license to market a generic version of Adderall XR if and when FDA approves it. That said the chance that Sandoz would pursue the application with two existing patents in play is doubtful.
“Sandoz is welcome to initiate and authorized generic once they get approval from the FDA,” Shire’s Director of Communications Matt Cabrey said.
As of right now, there are only two authorized generics approved and available to patients and both are manufactured by Shire-one for Teva and one for IMPAX Labs.
“We are bottling them and labeling them and shipping them to Teva and Impax respectively, and then they distribute them through their channels through wholesalers and pharmacies,” Cabrey said. “The difference is that it isn’t a true generic because none of the other pharmaceutical companies have gone through the exercise of clinical trials to demonstrate that they can produce the same exact molecule with the same exact efficacy and safety profile as the original.”
Shortly after Adderall XR was approved, five companies challenged Shire’s patent. From an investment perspective Shire was stuck in the notion that if it lost patent that the company would be in dire straits. In 2006, the executive team at Shire agreed to partner with Teva and IMPAX to mitigate concern.
“It helped to reassure investors that Shire had a plan in place to position our portfolio of drugs, and we knew we could put into place efforts around commercializing the new ADHD treatment Vivance,” Cabrey said. “That allowed us to concentrate on maximizing our investment in Vivance, which we purchased in 2007.”
According to Shire, Adderall has not lost patent protection, which has two primary patents that are exclusive through 2016 and 2018.
“Frankly, if we lost patent protection in the courts then we would see a very crowded field of Adderall XR, the way we have seen a crowded field of generic original Adderall,” Cabrey said.
Shire currently has a citizen petition in front of the FDA that acknowledges that Shire was told to engage in thorough clinical trials after the drug was approved in 2001. The company is asking that any firm that manufacturers a generic version of the drug should also place its drug under such scrutiny. FDA has yet to answer the petition.
Sandoz could not be reached for comment.