FERRIC MALTOL - Generic Drug Details

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What are the generic drug sources for ferric maltol and what is the scope of freedom to operate?

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

Generic Entry Date for FERRIC MALTOL^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Leiden University Medical Center	Phase 4
Maastricht 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

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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
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		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

EU/EMA Drug Approvals for FERRIC MALTOL

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for FERRIC MALTOL

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	201400171		⤷ Sign Up
Spain	2661944		⤷ Sign Up
United Kingdom	201419174		⤷ Sign Up
Japan	2011520855		⤷ Sign Up
United Kingdom	0808835		⤷ Sign Up
European Patent Office	2303289	COMPOSITIONS MONOCOMPOSÉ (D' HYDROXYPYRONE DE FER) ET DE COMBINAISON (D'HYDROXYPYRONE DE FER ET D'AGENTS INHIBITEURS D'INFLAMMATION GASTRO-INTESTINALES) POUR LUTTER CONTRE L'ANÉMIE OU DES INFECTIONS PAR H. PYLORI (MONO ( IRON HYDROXYPYRONE ) AND COMBINATION ( IRON HYDROXYPYRONE AND GI INFLAMMATION INHIBITING AGENTS ) COMPOSITIONS FOR ANAEMIA OR H. PYLORI INFECTIONS)	⤷ Sign Up
South Korea	102351422		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.