Adcirca’s revenue trends
In 4Q17, United Therapeutics’ (UTHR) Adcirca generated revenues of $119.3 million, up from $112.7 million in 4Q16, which reflected ~6.0% growth on a year-over-year (or YoY) basis and ~20.0% growth on a quarter-over-quarter basis.
In fiscal 2017, Adcirca reported revenues of $419.7 million, up from $372.2 million in 2016, which reflected ~12.8% growth on a YoY basis.
In November 2017, the FDA granted Adcirca pediatric patent exclusivity until May 2018. The FDA grant for extension of patent exclusivity was based on the clinical trial results submitted by Eli Lilly (LLY) in response to the FDA’s request to evaluate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy.
United Therapeutics commercializes Adcirca in the US market for the treatment of individuals with pulmonary arterial hypertension (or PAH) under the license agreement with Eli Lilly.
Orenitram’s revenue trends
In 4Q17, Orenitram generated revenues of $48.0 million, up from $38.3 million in 4Q16. This trend reflected ~25.0% growth on a YoY basis and a 9.0% decline quarter-over-quarter.
In fiscal 2017, Orenitram reported revenues of $185.8 million, up from $157.2 million in 2016, which reflected ~18.2% YoY growth.
In February 2018, United Therapeutics entered into a settlement agreement with Actavis Laboratories, which resolved ongoing patent litigation related to certain patents of United Therapeutics’ (UTHR) Orenitram extended-release tablets. Actavis Laboratories had filed an ANDA (Abbreviated New Drug Application) pursuing FDA approval to market a generic version of Orenitram.
According to the terms of the agreement between United Therapeutics and Actavis Laboratories, United Therapeutics granted Actavis Laboratories a license to manufacture and market the generic version of Orenitram starting on June 15, 2027.