Claims for Patent: 11,433,091

Summary for Patent: 11,433,091

Title:	Methods and compositions for administration of iron
Abstract:	The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
Inventor(s):	Mary Jane Helenek, Marc L. Tokars, Richard P. Lawrence
Assignee:	American Regent Inc
Application Number:	US15/958,930
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,433,091
Patent Claims:	1. A method of treating a disease, disorder, or condition characterized by iron deficiency or dysfunctional iron metabolism, comprising intravenously administering to a human subject in need thereof an iron carbohydrate complex in a single dosage unit of at least 0.7 grams of elemental iron in 15 minutes, wherein the disease, disorder, or condition is anemia. 2. The method of claim 1, wherein the anemia is iron deficiency anemia. 3. The method of claim 2, wherein the iron deficiency anemia is associated with chronic blood loss; acute blood loss; pregnancy; childbirth; childhood development; psychomotor and cognitive development in children; breath holding spells; heavy uterine bleeding; menstruation; chronic recurrent hemoptysis; idiopathic pulmonary siderosis; chronic internal bleeding; gastrointestinal bleeding; parasitic infections; chronic kidney disease; dialysis; surgery or acute trauma; and chronic ingestion of alcohol, chronic ingestion of salicylates, chronic ingestion of steroids; chronic ingestion of non-steroidal anti-inflammatory agents, or chronic ingestion of erythropoiesis stimulating agents. 4. The method of claim 1, wherein the anemia is anemia of chronic disease. 5. The method of claim 4, wherein the chronic disease is selected from the group consisting of rheumatoid arthritis; cancer; Hodgkin's leukemia; nonHodgkin's leukemia; cancer chemotherapy; inflammatory bowel disease; ulcerative colitis; thyroiditis; hepatitis; systemic lupus erythematosus; polymyalgia rheumatica; scleroderma; mixed connective tissue disease; Sjogren's syndrome; congestive heart failure/cardiomyopathy; and idiopathic geriatric anemia. 6. The method of claim 1, wherein the anemia is due to impaired iron absorption or poor nutrition. 7. The method of claim 1, wherein the anemia is associated with Crohn's Disease; gastric surgery; ingestion of drug products that inhibit iron absorption; and chronic use of calcium. 8. The method of claim 1, wherein the single dosage unit of elemental iron is at least 0.8 grams; at least 0.9 grams; at least 1.0 grams; at least 1.1 grams; at least 1.2 grams; at least 1.3 grams; at least 1.4 grams; at least 1.5 grams; at least 1.6 grams; at least 1.7 grams; at least 1.8 grams; at least 1.9 grams; at least 2.0 grams; at least 2.1 grams; at least 2.2 grams; at least 2.3 grams; at least 2.4 grams; or at least 2.5 grams. 9. The method of claim 8, wherein the single dosage unit of elemental iron is at least 1.0 grams. 10. The method of claim 9, wherein the single dosage unit of elemental iron is at least 1.5 grams. 11. The method of claim 10, wherein the single dosage unit of elemental iron is at least 2.0 grams. 12. The method of claim 11, wherein the single dosage unit of elemental iron is at least 2.5 grams. 13. The method of claim 1, wherein administration of the single dose is repeated. 14. The method of claim 1, wherein the iron carbohydrate complex is an iron carboxymaltose, iron mannitol, iron polyisomaltose, iron polymaltose, iron gluconate, iron sorbitol, or an iron hydrogenated dextran. 15. The method of claim 14, wherein the iron carbohydrate complex is an iron carboxymaltose complex. 16. The method of claim 15, wherein the iron carboxymaltose complex is polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate. 17. The method of claim 1, wherein the single unit dose of iron carbohydrate complex is intravenously infused at a concentration of about 1000 mg elemental iron in about 215 ml of diluent. 18. The method of claim 1, further comprising a second administration of the iron carbohydrate complex upon recurrence of at least one symptom of the disease or disorder. 19. The method of claim 1, further comprising a second administration of the iron complex 1 day to 12 months after the first administration. 20. A method of treating a disease, disorder, or condition characterized by iron deficiency or dysfunctional iron metabolism, comprising administering to a subject in need thereof an iron carbohydrate complex in a single dosage unit of at least 0.7 grams of elemental iron in less than 15 minutes, wherein the disease, disorder, or condition is anemia. 21. The method of claim 20, wherein the single dosage unit of elemental iron is at least 0.8 grams; at least 0.9 grams; at least 1.0 grams; at least 1.1 grams; at least 1.2 grams; at least 1.3 grams; at least 1.4 grams; at least 1.5 grams; at least 1.6 grams; at least 1.7 grams; at least 1.8 grams; at least 1.9 grams; at least 2.0 grams; at least 2.1 grams; at least 2.2 grams; at least 2.3 grams; at least 2.4 grams; or at least 2.5 grams. 22. The method of claim 20, wherein the single dosage unit of elemental iron is administered in less than 10 minutes. 23. The method of claim 20, wherein the single dosage unit of elemental iron is administered in less than 5 minutes. 24. The method of claim 20, wherein the single dosage unit of elemental iron is administered in less than 2 minutes. 25. The method of claim 20, wherein the single dosage unit of elemental iron is administered intravenously. 26. The method of claim 20, wherein the iron carbohydrate complex is an iron carboxymaltose, iron mannitol, iron polyisomaltose, iron polymaltose, iron gluconate, iron sorbitol, or an iron hydrogenated dextran. 27. The method of claim 26, wherein the iron carbohydrate complex is an iron carboxymaltose complex. 28. The method of claim 26, wherein the iron carbohydrate complex is an iron polyisomaltose complex.