Sandoz challenges United Thera's Remodulin patents

6 February 2012

US drugmaker United Therapeutics (Nasdaq: UTHR) says that it has received a Paragraph IV Certification Notice Letter from Sandoz Inc, a US subsidiary of Swiss drug major Novartis (NOVN: VX), saying that the generics unit has submitted an Abbreviated New Drug Application) to the US Food and Drug Administration requesting approval to market a generic version of the 10mg/mL strength of its pulmonary arterial hypertensions drug Remodulin (treprostinil) injection.

In this, Sandoz stated that it intends to market a generic version of Remodulin before the expiration of US Patent No 5,153,222, which expires in October 2014; US Patent No 6,765,117, which expires in October 2017; and US Patent No 7,999,007, which expires in March 2029. Sandoz' letter states that the ANDA contains a Paragraph IV Certification alleging that these patents 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.

United will defend its IP relating to the drug

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