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Ferric carboxymaltose - Generic Drug Details

What are the generic sources for ferric carboxymaltose and what is the scope of ferric carboxymaltose patent protection?
Ferric carboxymaltose is the generic ingredient in one branded drug marketed by Luitpold Pharms Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric carboxymaltose has sixty-six patent family members in thirty-one countries.

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

Summary for ferric carboxymaltose

International Patents:	66
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	16
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Clinical Trials:	143
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric carboxymaltose
DailyMed Link:	ferric carboxymaltose at DailyMed

Pharmacology for ferric carboxymaltose

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

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
Luitpold Pharms Inc	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Luitpold Pharms Inc	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Luitpold Pharms Inc	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Luitpold Pharms Inc	INJECTAFER	ferric carboxymaltose	INJECTABLE;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y			➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Non-Orange Book US Patents for ferric carboxymaltose

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

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Patent No.	Title	Estimated Patent Expiration
8,431,549	Methods and compositions for administration of iron	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration