Shire sues Sandoz and Amneal for Vyvanse patent infringements

5 July 2011

Ireland-headquartered drugmaker Shire (LSE: SHP) says it has filed law suits in the US District Court for the District of New Jersey against each of privately-held US generic drugmaker Amneal Pharmaceuticals and Sandoz Inc, the US generics subsidiary of Swiss drug major Novartis (NOVN: VX) for infringement of certain of Shire's attention-deficit hyperactivity disorder (ADHA) treatment Vyvanse (lisdexamfetamine dimesylate) patents.

The law suits were initiated in response to Abbreviated New Drug Applications filed by Amneal and Sandoz seeking US Food and Drug Administration approval to market and sell generic versions of all currently approved doses of Vyvanse.

When Sandoz issued a Paragraph IV notice letter advising Shire that it had filed an ANDA for the drug (The Pharma Letter May 20), Shire said this was the first patent challenge and pointed out that Vyvanse is protected by 16 patents, all of which expire in 2023. The drug generated sales of $634 million last year.

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