Shire chalks up victory in Vyvanse patent battle

Shire ($SHPG) relies on its ADHD med Vyvanse to bring home the bacon, raking in more than a quarter of its revenues from the med. Now the Irish drugmaker is celebrating a victory as a U.S. Court of Appeals upheld Shire's patents for the med, shielding Vyvanse from generic competition while protecting its bottom line even as it has launched a $30 billion buyout run at Baxalta ($BXLT).

The appeals court backed an earlier District Court ruling which rejected claims that Shire's patents for Vyvanse are invalid. With the latest ruling in hand, Shire may not see generics to Vyvanse until its patents expire in 2023.

As PharmaTimes reports, drugmakers including Actavis, Mylan ($MYL) and Sandoz were itching to launch copycat versions of the med, prompting Shire to file a string of patent infringement suits between 2011 and 2012. But while the company is "extremely pleased" with the latest appeals court's decision, the ruling could still be appealed, it told PharmaTimes, opening the door to more litigation over the med.

Still, the patent battle victory strengthens its position as it continues to churn out blockbuster sales for its best-selling product. Vyvanse raked in $841.6 million in sales during the first half of 2015, about 28% of the company's total revenue.

New indications helped add to that haul. In February, the FDA approved the drug to treat binge-eating disorder, an indication that could help the med rake in an extra $200 million to $300 million, Shire said at the time. The BED indication could also move the company one step closer to achieving its dream of $10 billion in product sales by 2020. It also is testing Vyvanse in preschool-aged children in ADHD, eyeing 6-month pediatric exclusivity for the med.

The patent win also comes as Shire makes a play for Baxalta. In July, the company laid out a $30 billion bid for the Illinois pharma, only 9 days after Baxalta spun off from Baxter ($BAX). Baxalta has since warded off Shire's advances, but Shire isn't showing any signs of giving up. The Dublin-based company last week said it is considering getting cash to Baxalta shareholders sooner, sweetening its bid for the company to speed the deal along.

- read the PharmaTimes story

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