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Last Updated: March 29, 2024

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INJECTAFER Drug Patent Profile


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Which patents cover Injectafer, and what generic alternatives are available?

Injectafer is a drug marketed by Am Regent and is included in one NDA. There are six patents protecting this drug and three Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-two countries.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

DrugPatentWatch® Generic Entry Outlook for Injectafer

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2026. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for INJECTAFER
Drug Prices for INJECTAFER

See drug prices for INJECTAFER

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INJECTAFER
Generic Entry Date for INJECTAFER*:
Constraining patent/regulatory exclusivity:
TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
NDA:
Dosage:
INJECTABLE;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INJECTAFER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Baylor College of MedicinePhase 3
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
M.D. Anderson Cancer CenterPhase 2

See all INJECTAFER clinical trials

Pharmacology for INJECTAFER
Paragraph IV (Patent) Challenges for INJECTAFER
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
INJECTAFER Injection ferric carboxymaltose 100 mg/2 mL 203565 1 2022-09-23
INJECTAFER Injection ferric carboxymaltose 1 g/20 mL 203565 1 2022-02-15
INJECTAFER Injection ferric carboxymaltose 750 mg/15 mL 203565 1 2019-03-27

US Patents and Regulatory Information for INJECTAFER

INJECTAFER is protected by twenty-six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INJECTAFER is ⤷  Try a Trial.

This potential generic entry date is based on TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INJECTAFER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS

Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULTS WHO HAVE INTOLERANCE TO OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR A GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 GRAMS OF ELEMENTAL IRON

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER HAVING INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON ASSOCIATED WITH HEAVY UTERINE BLEEDING OR GASTROINTESTINAL DISORDER BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING ABOUT 1 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IDA IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON IN ABOUT ≤ 15 MIN

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IDA IN ADULT PATIENTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING AT LEAST ABOUT 0.6 GRAMS OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MINUTES OR LESS

Methods and compositions for administration of iron
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD TO TREAT IDA IN ADULTS & PEDIATRIC PATIENTS 1 YR & OLDER WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY ADMINISTERING IV AT LEAST ABOUT 0.6 G OF IRON AS FERRIC CARBOXYMALTOSE IN ABOUT 15 MIN OR LESS

FDA Regulatory Exclusivity protecting INJECTAFER

NEW STRENGTH
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEARTASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for INJECTAFER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 ⤷  Try a Trial ⤷  Try a Trial
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for INJECTAFER

See the table below for patents covering INJECTAFER around the world.

Country Patent Number Title Estimated Expiration
China 100480275 ⤷  Try a Trial
Jordan P20180046 متراكبات مائية من حديد وكربوهيدرات، إنتاجها وأدوية تحتوي عليها (Aqueous iron carbohydrate complexes, their production and medicaments containing them) ⤷  Try a Trial
South Korea 20180077337 철을 투여하기 위한 방법 및 조성물 (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON) ⤷  Try a Trial
Germany 50313653 ⤷  Try a Trial
Spain 2385788 ⤷  Try a Trial
Portugal 2287204 ⤷  Try a Trial
Mexico PA05004300 COMPLEJOS DE HIERRO-CARBOHIDRATO SOLUBLES EN AGUA, PRODUCCION DE LOS MISMOS, Y MEDICAMENTOS QUE LOS CONTIENEN. (WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INJECTAFER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1554315 C01554315/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.