United Therapeutics has been granted a patent for a method of treating interstitial lung disease (ILD) using treprostinil. The method aims to reduce pulmonary function decline and increase forced vital capacity in ILD patients. The patent also includes a claim for improving exercise capacity in ILD patients with pulmonary hypertension through inhalation of treprostinil. GlobalData’s report on United Therapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on United Therapeutics, Cancer treatment biomarkers was a key innovation area identified from patents. United Therapeutics's grant share as of September 2023 was 46%. Grant share is based on the ratio of number of grants to total number of patents.

Treating interstitial lung disease with treprostinil inhalation

Source: United States Patent and Trademark Office (USPTO). Credit: United Therapeutics Corp

A recently granted patent (Publication Number: US11730710B2) describes a method for improving exercise capacity in patients with pulmonary hypertension associated with interstitial lung disease. The method involves administering treprostinil or a pharmaceutically acceptable salt thereof through inhalation in a single administration event. The administered dose should be at least 15 micrograms, up to a maximum tolerated dose, with a minimum of 6 micrograms per breath.

The patent claims that this method results in several positive outcomes for the patients. Firstly, it states that the administration of treprostinil leads to a statistically significant increase in the 6-minute walk distance of the patient after 8, 12, or 16 weeks of treatment. Additionally, it claims that the method increases the 6-minute walk distance by at least 10 meters after the same duration of treatment.

Furthermore, the patent asserts that the administration of treprostinil results in a statistically significant reduction in the plasma concentration of NT-proBNP, a biomarker associated with heart failure, after 8, 12, or 16 weeks of treatment. It specifies that the reduction should be at least 200 pg/ml.

The method also claims to provide a statistically significant reduction in exacerbations of the interstitial lung disease and clinical worsening events associated with it. These events include hospitalization for cardiopulmonary indications and a decrease in the 6-minute walk distance by more than 15% compared to the baseline measurement prior to treatment.

Moreover, the patent suggests that the method improves forced vital capacity (FVC) in the patient after 8, 12, or 16 weeks of treatment. It states that the improvement should be at least 20 ml.

The patent further describes the use of a pulsed inhalation device, such as a nebulizer or a dry powder inhaler, for administering the treprostinil. It specifies that the effective amount of treprostinil or its salt should be between 15 µg and 100 µg in a single inhalation administration event, which should not exceed 15 breaths.

In conclusion, this granted patent presents a method for improving exercise capacity in patients with pulmonary hypertension associated with interstitial lung disease through the inhalation administration of treprostinil. The method claims to result in various positive outcomes, including increased 6-minute walk distance, reduced plasma concentration of NT-proBNP, decreased exacerbations and clinical worsening events, and improved forced vital capacity. The use of a pulsed inhalation device is also described in the patent.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies