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Shire's Vyvanse tops $1B as more generics challenge Adderall

Teva gets FDA approval for its own version of ADHD drug
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Vyvanse broke into blockbuster territory last year.--Courtesy of Shire

Changes are apace at Shire ($SHPG), the Irish specialty drugmaker that is something of a darling of the industry. A new top exec will take over in April, but in his last earnings report while at the helm, Angus Russell got to tell investors he leaves the house in order.

In fact, while generic versions of its blockbuster Adderall XR are now on the market, its ADHD replacement Vyvanse broke into blockbuster territory last year. "Vyvanse has achieved blockbuster status, delivering a 28% increase in revenues to over $1 billion for the first time," Reuters reported Russell saying Thursday. The CEO will leave at the end of April, passing the reins to Dr. Flemming Ørnskov, who is in-house preparing for the role.

The explosion in sales of Vyvanse comes just in the nick of time. Teva Pharmaceutical Industries ($TEVA), which has been making an approved generic of Adderall XR, said Thursday that the FDA had approved its own generic version. According to Reuters, Shire said that Adderall XR sales were already off nearly 20% to $429 million in 2012 in the face of new competition from a copy made by Actavis ($ACT). But with Vyvanse and other drug sales growing, the company said it expects earnings this year to be in line with expectations. Analysts forecast that to be a 10% increase.

While drugs for attention deficit hyperactivity disorder are not the only kinds of medicines Shire makes, its portfolio of those drugs has been its foundation. In fact, the company has had such a grip on that market that it has sparked interest from federal authorities. Last week the company said that it had set aside $57.5 million in its fourth quarter to settle a case with federal regulators over its marketing of Adderall XR, Vyvanse and its ADHD patch Daytrana. U.S. authorities have yet to acknowledge any agreement.

- read the Reuters story
- here's the earnings release

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FDA hits Shire with early nod for Adderall XR copycat

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