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Last Updated: April 17, 2024

Ferric carboxymaltose - Generic Drug Details


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What are the generic sources for ferric carboxymaltose and what is the scope of freedom to operate?

Ferric carboxymaltose is the generic ingredient in one branded drug marketed by Am Regent and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric carboxymaltose has seventy-one patent family members in thirty-two countries.

There are two drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ferric carboxymaltose
Generic Entry Date for ferric carboxymaltose*:
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
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 ferric carboxymaltose

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

SponsorPhase
Jon UnossonPhase 3
University of PadovaPhase 4
Tomsk National Research Medical Center of the Russian Academy of SciencesPhase 4

See all ferric carboxymaltose clinical trials

Pharmacology for ferric carboxymaltose
Paragraph IV (Patent) Challenges for FERRIC CARBOXYMALTOSE
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 ferric carboxymaltose

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 203565-003 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
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 203565-002 Oct 8, 2020 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
>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 ferric carboxymaltose

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 203565-003 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 203565-002 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ferric carboxymaltose

Country Patent Number Title Estimated Expiration
Brazil PI0318840 complexo de carboidrato de ferro (iii) hidrossolúvel e uso do mesmo ⤷  Try a Trial
Norway 20110654 ⤷  Try a Trial
Canada 2493806 COMPLEXES FER/HYDRATE DE CARBONE HYDROSOLUBLES, LEUR PRODUCTION ET MEDICAMENTS CONTENANT CES COMPLEXES (WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004037865 ⤷  Try a Trial
Denmark 1973549 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ferric carboxymaltose

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.