Dive Brief:
- Shire won a patent infringement suit, which validates integrity of the patents on its ADHD drug Vyvanse (lisdexamfetamine).
- The manufacturers who have filed abbreviated new drug applications (ANDAs) are now prohibited from launching generic versions of Vyvanse until expiration of all associated patents in 2023.
- Shire will soon start testing Vyvanse in preschoolers. If approved for this age group, Vyvanse will be granted an additional six months of exclusivity.
Dive Insight:
Shire has firmly rejected AbbVie’s $46.4 billion takeover bid and is determined to remain independent. Vyvanse is an important part of this strategy. Fourth quarter sales were $329.9 million. In addition to efforts to expand the indication to include preschool children (Vyvanse is currently approved for patients aged six and above), Shire also plans to file Vyvanse in the US for binge-eating disorders.