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.

Summary for ferric carboxymaltose

International Patents:	71
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	128
Patent Applications:	105
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric carboxymaltose
DailyMed Link:	ferric carboxymaltose at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ferric carboxymaltose

Generic Entry Date for ferric carboxymaltose^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION 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

Sponsor	Phase
Suzhou Guochen Biotek Co., Ltd.	Phase 1
Sichuan Huiyu Pharmaceutical Co., Ltd	Phase 1
Boji Medical Technology Co., Ltd.	Phase 1

See all ferric carboxymaltose clinical trials

Pharmacology for ferric carboxymaltose

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for FERRIC CARBOXYMALTOSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INJECTAFER	Injection	ferric carboxymaltose	500 mg/10 mL	203565	1	2024-02-22
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

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Glossary

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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	203565-004	Feb 4, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for ferric carboxymaltose

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Country	Patent Number	Title	Estimated Expiration
Malaysia	134394	AQUEOUS IRON CARBOHYDRATE COMPLEXES, THEIR PRODUCTION AND MEDICAMENTS CONTAINING THEM	⤷ Sign Up
Japan	5289413		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004037865		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ferric carboxymaltose

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1554315	C01554315/01	Switzerland	⤷ Sign Up	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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