Claims for Patent: 10,231,975

Summary for Patent: 10,231,975

Title:	Use of aerosolized levofloxacin for treating cystic fibrosis
Abstract:	Methods for treating cystic fibrosis. The method includes administering to a human in need thereof an aerosol solution comprising levofloxacin or ofloxacin and a divalent or trivalent cation. More particularly, the method includes administering the aerosol solution to a human having a pulmonary infection comprising P. aeruginosa.
Inventor(s):	Loutit; Jeffery S. (Los Altos, CA), Morgan; Elizabeth E. (Escondido, CA), Dudley; Michael N. (San Diego, CA), Griffith; David C. (San Marcos, CA), Lomovskaya; Olga (Mountain View, CA)
Assignee:	Horizon Orphan LLC (Lake Forest, IL)
Application Number:	15/623,168
Patent Claims:	1. A method for treating a pulmonary Pseudomonas aeruginosa infection in a human in need thereof, the method comprising administering via inhalation 240 mg of levofloxacin twice daily for 28 days to the human to treat the pulmonary Pseudomonas aeruginosa infection; wherein the levofloxacin is in a solution comprising 90 mg/ml to 110 mg/ml of levofloxacin and 175 mM to 225 mM of a magnesium cation. 2. The method of claim 1, wherein the magnesium cation is in the form of magnesium chloride. 3. The method of claim 2, wherein the solution comprises 100 mg/ml of levofloxacin and 200 mM of magnesium chloride. 4. The method of claim 1, wherein the magnesium cation is in the form of magnesium sulfate. 5. The method of claim 1, wherein the solution is administered by a vibrating mesh nebulizer. 6. The method of claim 1, wherein the solution has a pH from 5 to 7, and an osmolality from 300 mOsmol/kg to 500 mOsmol/kg. 7. The method of claim 1, further comprising administering dornase alpha, azithromycin, salbutamol, pancrelipase, sodium chloride, seretide, vitamin A, vitamin D, vitamin E, vitamin K, or a combination of two or more thereof. 8. The method of claim 1, wherein the human is a pediatric patient. 9. The method of claim 1, wherein the human has cystic fibrosis. 10. A method for treating a pulmonary Pseudomonas aeruginosa infection in a human in need thereof, the method comprising administering via inhalation 240 mg of levofloxacin twice daily for 28 days to the human to treat the pulmonary Pseudomonas aeruginosa infection; wherein the levofloxacin is in a solution comprising 90 mg/ml to 125 mg/ml of levofloxacin and 150 mM to 250 mM of a cation, wherein the cation is a magnesium cation, a calcium cation, a zinc cation, a copper cation, an aluminum cation, or an iron cation. 11. The method of claim 10, wherein the cation is the zinc cation. 12. The method of claim 11, wherein the zinc cation is in the form of zinc chloride. 13. The method of claim 10, wherein the cation is the copper cation. 14. The method of claim 13, wherein the copper cation is in the form of copper chloride. 15. The method of claim 10, wherein the cation is the magnesium cation. 16. The method of claim 15, wherein the magnesium cation is in the form of magnesium chloride. 17. The method of claim 15, wherein the magnesium cation is in the form of magnesium sulfate. 18. The method of claim 10, wherein the solution has a pH from 5 to 7, and an osmolality from 300 mOsmol/kg to 500 mOsmol/kg. 19. The method of claim 10, wherein the human is a pediatric patient. 20. The method of claim 19, wherein the pediatric patient has cystic fibrosis.

Details for Patent 10,231,975

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Organon Usa Inc., A Subsidiary Of Merck & Co., Inc.	COTAZYM	pancrelipase	Capsule, Delayed Release	020580	12/09/1996		2029-09-04
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725	04/30/2009		2029-09-04
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725	06/10/2011		2029-09-04
Abbvie Inc.	CREON	pancrelipase	Capsule, Delayed Release	020725	03/14/2013		2029-09-04
Digestive Care, Inc.	PERTZYE	pancrelipase	Capsule, Delayed Release	022175	05/17/2012		2029-09-04