United Therapeutics Corp (NASDAQ: UTHR), which has an office in the Research Triangle, has received approval of a new inhalation device from the U.S. Food and Drug Administration (FDA) for use with its drug Tyvaso. Tyvaso, has been the focal point of a number of patent disputes. A treatment for pulmonary hypertension (PAH), the drug generates significant sales for the company.
In the first six months of 2017, it accounted for $192 million in sales. The Silver Springs, Maryland-based company reported approximately $1.6 billion in total revenue in 2016.
Tyvaso is the most-prescribed inhalation therapy for PAH in the United States, and since its launch, United Therapeutics has been working on improvements to the Tyvaso Inhalation System to aid patient compliance and enhance ease of use.
The company says the TD-300/A is “a significant step forward on that front.” Designed based on patient and physician feedback, the new device has a more ergonomic design that includes single button operation, an intuitive user interface for adjusting breath counts, a color, graphical display that leads patients through the inhalation process and displays time since last treatment, and an internal, rechargeable battery.
The U.S. Patent and Trademark office declared a United Therapeutics patent related to the drug treprostinil, which United Therapeutics markets under several brand names, including Tyvaso.
The ruling was made in early 2016 in response to a challenge of the patent’s validity filed in October 2015 by SteadyMed.
