Remodulin revenue trends
In 2016, United Therapeutics’ (UTHR) Remodulin reported revenues of ~$602.3 million, which reflected ~5.0% year-over-year (or YoY) growth. Remodulin contributed ~38.0% of the company’s total revenues. In 1Q17, the drug generated revenues of ~$145.8 million, which represents 4.0% growth YoY but a 4.0% decline on its quarter-over-quarter sales.
The chart below represents the revenue trajectory of Remodulin from 1Q16 to 1Q17. To learn more about the drug, please read Could Generic Competition Impact United Therapeutics’ Remodulin Sales after June 2018?
Remodulin (treprostinil) is a prostacyclin analog indicated for the treatment of patients with pulmonary arterial hypertension (or PAH). In 2002, the drug was approved by the FDA as a continuous subcutaneous therapy.
In 2004, the FDA approved Remodulin for continuous intravenous infusion therapy. The drug received approval in 39 countries as continuous subcutaneous administration as well as in 35 countries as a continuous intravenous infusion.
The drug faces stiff competition from GlaxoSmithKline’s (GSK) and Teva Pharmaceuticals’ (TEVA) Flolan, Actelion Pharmaceuticals’ Veletri, and generic epoprostenol. Flolan and other generic epoprostenol require the use of cooling packs due to their instability at room temperature.
Veletri is stable at room temperature but has a shorter half-life than Remodulin. All the competitive products have been approved for intravenous administration, and Remodulin is the only product approved for both intravenous and subcutaneous administration.
United Therapeutics settled three patent litigation lawsuits with Sandoz, Teva Pharmaceuticals, and Par Sterile Products for filing abbreviated new drug applications (or ANDAs) to the FDA for marketing approval of generic versions of Remodulin.
In the US, Novartis (NVS), through its subsidiary Sandoz, has been permitted to launch its generic version of Remodulin in June 2018. Teva Pharmaceuticals and Par Sterile Products can launch their generic versions in December 2018.
The growth in sales of United Therapeutics’ Remodulin may boost the Vanguard Small-Cap Value ETF (VBR). United Therapeutics holds ~0.33% of VBR’s total portfolio holdings.
In the next article, we’ll discuss Tyvaso.