Ferric maltol - Generic Drug Details

What are the generic sources for ferric maltol and what is the scope of patent protection?

Ferric maltol is the generic ingredient in one branded drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric maltol has fifty-one patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for ferric maltol

International Patents:	51
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	12
Patent Applications:	42
What excipients (inactive ingredients) are in ferric maltol?	ferric maltol excipients list
DailyMed Link:	ferric maltol at DailyMed

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

Dosage:

CAPSULE;ORAL

^*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 maltol

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

Sponsor	Phase
Norgine	Phase 4
University Medical Center Groningen	Phase 4
Radboud University Medical Center	Phase 4

See all ferric maltol clinical trials

Pharmacology for ferric maltol

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

Anatomical Therapeutic Chemical (ATC) Classes for ferric maltol

B03AB	Iron trivalent, oral preparations
B03A	IRON PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for ferric maltol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes			Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for ferric maltol

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Norgine B.V.	Feraccru	ferric maltol	EMEA/H/C/002733 Feraccru is indicated in adults for the treatment of iron deficiency.	Authorised	no	no	no	2016-02-18

International Patents for ferric maltol

Country	Patent Number	Title	Estimated Expiration
Japan	2018197268	マルトール第二鉄の結晶形態 (CRYSTAL FORM OF FERRIC MALTOL)
Japan	5769308
Israel	246613	משטר מינון של ברזל טרימלטול (Dosage regimen of ferric trimaltol)
China	114010629	三麦芽酚铁的剂量方案 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
Eurasian Patent Organization	033323	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА (CRYSTALLINE FORMS OF FERRIC MALTOL)
Saudi Arabia	517381406	صور بلورية من مالتول الحديديك (Crystalline Forms of Ferric Maltol)