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INJECTAFER Drug Profile

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When do Injectafer patents expire, and when can generic versions of Injectafer launch?

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

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 February 5, 2024. This may change due to patent challenges or generic licensing.

There have been four 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

Summary for INJECTAFER

International Patents:	71
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	16
Drug Prices:	Drug price information for INJECTAFER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INJECTAFER
What excipients (inactive ingredients) are in INJECTAFER?	INJECTAFER excipients list
DailyMed Link:	INJECTAFER at DailyMed

See drug prices for INJECTAFER

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for INJECTAFER

NDA:

203565

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

Sponsor	Phase
Baylor College of Medicine	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Sandoz	Phase 1

See all INJECTAFER clinical trials

Pharmacology for INJECTAFER

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

Paragraph IV (Patent) Challenges for INJECTAFER

Tradename	Dosage	Ingredient	NDA	Submissiondate
INJECTAFER	SOLUTION;INTRAVENOUS	ferric carboxymaltose	203565	2019-03-27

US Patents and Regulatory Information for INJECTAFER

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	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes			Y	Y
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes			Y	Y
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes			Y	Y
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes

International Patents for INJECTAFER

Country	Patent Number	Estimated Expiration
Norway	335770
China	100480275
European Patent Office	2287204
European Patent Office	2626074
Portugal	1973549
South Korea	20170028449