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Last Updated: January 30, 2023

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 eight 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.

Recent Clinical Trials for ferric carboxymaltose

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

SponsorPhase
Pharmacosmos Therapeutics, Inc.Phase 3
Asan Medical CenterPhase 3
Hospital de Santa Cruz, PortugalPhase 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ferric carboxymaltose

Country Patent Number Title Estimated Expiration
Germany 10249552 Wasserlösliche Eisen-Kohlenhydrat-Komplexe, deren Herstellung und diese enthaltende Arzneimittel See Plans and Pricing
Canada 2953964 METHODES ET COMPOSITIONS POUR L'ADMINISTRATION DE FER (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON) See Plans and Pricing
Spain 2364136 See Plans and Pricing
Jordan 3286 متراكبات مائية من حديد و كربوهيدرات,انتاجها و ادوية تحتوي عليها (AQUEOUS IRON CARBOHYDRATE COMPLEXES,THEIR PRODUCTION AND MEDICAMENTS CONTAINING THEM) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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