ARTICLE | Company News

United Therapeutics, Novartis cardiovascular, generics news

February 13, 2012 8:00 AM UTC

United Therapeutics received a Paragraph IV notification letter from Sandoz, the generics unit of Novartis, indicating that it submitted an ANDA to FDA for a generic version of United Therapeutics' 10 mg/ml Remodulin treprostinil injection. The Paragraph IV claim relates to U.S. Patent Nos. 5,153,222, 6,765,117 and 7,999,007, which cover the drug and expire in 2014, 2017 and 2029, respectively. Sandoz alleges that the patents are invalid, unenforceable and/or will not be infringed by the generic. United Therapeutics, which is reviewing the letter, said it plans to enforce its IP. ...