United Therapeutics sues Sandoz over Remodulin patent infringement
United Therapeutics (Nasdaq: UTHR) says that it has filed a law suit in the US District Court for the District of New Jersey against Sandoz, the generic drug unit of Swiss drug major Novartis (NOVN: VX), for infringement of US patents relating to its pulmonary arterial hypertension drug Remodulin (treprostinil) injection.
Remodulin is United Therapeutics biggest selling product, generating revenues of around $430 million last year, or more than half of total group turnover of $743.2 million in 2011.
The suit is based on an Abbreviated New Drug filed by Sandoz with the US Food and Drug Administration last month requesting approval to market a generic version of the 10mg/mL strength of Remodulin (The Pharma Letter February 6). Sandoz' ANDA alleges that the three patents mentioned in the suit are not valid, not enforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Sandoz's ANDA submission.
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