Shire has filed lawsuits against Roxane Laboratories Inc. and Watson Laboratories Inc. for infringement of Shire patents covering Vyvanse, used to treat ADHD.
Biopharmaceutical company Shire has filed lawsuits against Roxane Laboratories Inc. and Watson Laboratories Inc. for infringement of Shire patents covering Vyvanse (lisdexamfetamine), the company’s prescription medicine for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and adults.
The lawsuits were initiated in response to Abbreviated New Drug Applications (ANDAs) filed by Roxane and Watson seeking FDA approval to market and sell generic versions of all currently approved doses of Vyvanse.
“Under the Hatch-Waxman Act, the FDA must refrain from approving the Roxane and Watson ANDAs before August 23, 2014, or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier,” according to a statement release by Shire.
Shire will provide details of any additional Paragraph IV certifications received advising of ANDA filings on Vyvanse, and any litigation that is subsequently initiated, in its periodic filings on Forms 10-Q and 10-K.
Vyvanse is Shire’s biggest-selling product, and most sales are made in the US. “Shire reported a total of $623.4 million in Vyvanse revenue in 2010 and said the drug had a 15% share of the US market,” according to the Associated Press.
Shire said the first patent supporting Vyvanse does not expire until June 2023. Vyvanse is also approved in Canada and Brazil, and Shire hopes to gain approval from European regulators in 2012. It is also studying Vyvanse as a treatment for other conditions.
Shire, which is based in Dublin, Ireland, became the top candidate to develop the first approved drug to combat binge-eating disorder. The company said Vyvanse may limit binging by interacting with brain chemicals that affect mood, motivation, and inhibition, according to Bloomberg News.
Shire expects binge-eating data on Vyvanse next year from the second trial phase of three generally required for U.S. marketing approval. The company is also testing the medicine for major depression, schizophrenia and excessive daytime sleepiness.