Last Updated: September 25, 2026

Details for Patent: 11,433,091


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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 Claim Types:
see list of patent claims
Use; Delivery;

Drugs Protected by US Patent 11,433,091

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES ⤷  Start Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES ⤷  Start Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YEAR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.7 G OF IRON IN 15 MINUTES ⤷  Start Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 46.7 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN < 15 MINUTES ⤷  Start Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING IDA IN ADULT PATIENTS WEIGHING AT LEAST 46.7 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES ⤷  Start Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN 15 MINUTES ⤷  Start Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 46.7 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.7 G OF ELEMENTAL IRON IN LESS THAN 15 MINUTES ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,433,091

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007205167 ⤷  Start Trial
Canada 2635894 ⤷  Start Trial
Canada 2953964 ⤷  Start Trial
China 101365458 ⤷  Start Trial
Cyprus 1118780 ⤷  Start Trial
Denmark 1973549 ⤷  Start Trial
European Patent Office 1973549 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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