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Sandoz Accuses United Therapeutics Of Blocking Generic Remodulin

Executive Summary

A Sandoz lawsuit has accused United Therapeutics of trying to illegally block sales of the first US generic version of Remodulin.

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Sandoz Launches An Exclusive Remodulin Rival In The US

Sandoz has claimed the first US launch of a generic rival to Remodulin with 180-day exclusivity, following a settlement deal struck with United Therapeutics four years ago.

Remodulin accelerated approval

United Therapeutics' pulmonary arterial hypertension therapy Remodulin (treprostinil) clears FDA May 21 via accelerated approval. The company's Phase IV confirmatory study will assess safety and efficacy of the drug in approximately 100 PAH patients who were stable on GlaxoSmithKline's Flolan (epoprostenol). Subjects will be withdrawn from Flolan and randomized to Remodulin or placebo for eight weeks. Remodulin is indicated for use in PAH "patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise." The drug is given as a continuous subcutaneous infusion via a portable infusion pump, while Flolan, indicated for PAH patients with NYHA Class III and IV symptoms, requires intravenous administration through a central venous cathete

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Dr Reddy’s Laboratories reported an unexpected third-quarter consolidated net loss after taking a $156m charge related to its generic version of the NuvaRing contraceptive. However, the company’s shares jumped on a robust underlying performance that was praised by analysts.

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