Claims for Patent: 11,357,782

Summary for Patent: 11,357,782

Title:	Treprostinil administration by inhalation
Abstract:	Treprostinil can be administered using a metered dose inhaler. Such administration provides a greater degree of autonomy to patients. Also disclosed are kits that include a metered dose inhaler containing a pharmaceutical formulation containing treprostinil.
Inventor(s):	Horst Olschewski, Robert Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl Sterritt, Robert Voswinckel
Assignee:	United Therapeutics Corp
Application Number:	US17/486,721
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,357,782
Patent Claims:	1. A method of treating pulmonary hypertension comprising: providing an inhalation device for treating pulmonary hypertension in a human suffering from pulmonary hypertension comprising a powder formulation of treprostinil or a pharmaceutically acceptable salt thereof and a dry powder inhaler configured to administer single event dose of the powder formulation comprising treprostinil or a pharmaceutically acceptable salt thereof, wherein the single event dose comprises at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths, wherein the dry powder inhaler is configured to administer the entire single event dose in less than 5 minutes with at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof being inhaled per breath through coordinated actuation of the dry powder inhaler with each breath, and administering to a human suffering from pulmonary hypertension with the dry powder inhaler the single event dose comprising at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in 1 to 3 breaths, wherein the human administers the entire single event dose with the dry powder inhaler in less than 5 minutes by inhaling at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof per breath by coordinating one actuation of the dry powder inhaler for each separate breath, and wherein administration of an additional single event dose in the same manner occurs at least 3 hours later. 2. The method of claim 1, further comprising administering at least 3 hours later an additional single event dose comprising at least 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof in 1 to 3 breaths, wherein the human administers the entire single event dose with the inhalation device in less than 5 minutes by inhaling at least 5 micrograms of treprostinil or a pharmaceutically acceptable salt thereof per breath by coordinating one actuation of the dry powder inhaler for each separate breath. 3. The method of claim 1, wherein the human administers the single event dose several times per day. 4. The method of claim 1, wherein the powder formulation comprises particles less than 5 micrometers in diameter. 5. The method of claim 1, wherein the powder formulation contains no metacresol. 6. The method of claim 1, wherein the human inhales each single event dose in less than about 1 minute. 7. The method of claim 1, wherein the dry powder inhaler is configured to administer at least 15 micrograms of treprostinil or its pharmaceutically effective salt per breath and the human inhales at least 15 micrograms of treprostinil or a pharmaceutically acceptable salt thereof per breath by coordinating one actuation of the dry powder inhaler for each separate breath. 8. The method of claim 1, wherein the single event dose provides a maximal treprostinil plasma concentration in the human of at least 0.65±0.28 ng/ml. 9. The method of claim 1, wherein the single event dose provides a peak plasma concentration of treprostinil in the human at about 10-15 minutes after inhalation. 10. The method of claim 1, wherein the single event dose comprises from 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof. 11. The method of claim 6, wherein the time between breaths is about 6 seconds.