Shire gets FDA backing on Vyvanse

Hear the shouts of joy from Shire? The FDA has validated five years of market exclusivity for Shire's attention-deficit drug Vyvanse. That's big news; the company is relying on Vyvanse to help make up lost revenue from the off-patent Adderall. And Shire has had Actavis nipping at its heels, aiming to flood the market with its own version of the medication.

In fact, Actavis sued FDA to overturn Vyvanse's protection, saying the drug is too similar to Adderall to qualify for exclusivity. Obviously, the agency disagreed--which keeps Actavis and other generic competition at bay.

Vyvanse's exclusivity will run out in early 2012, but between now and then Shire has the chance to milk billions from the drug. According to Reuters, forecasts put Vyvanse sales at $504 million this year and predict an increase to $1.06 billion by 2013. Part of the reason for those upbeat forecasts is that GlaxoSmithKline has signed on to co-promote the drug, boosting Vyvanse sales coverage to some 1,300 reps.

- check out the Shire press release
- see the news from Reuters