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Last Updated: March 29, 2024

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*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
NorginePhase 4
Leiden University Medical CenterPhase 4
Maastricht University Medical CenterPhase 4

See all FERRIC MALTOL clinical trials

Pharmacology for FERRIC MALTOL

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shield Tx ACCRUFER ferric maltol CAPSULE;ORAL 212320-001 Jul 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Shield Tx ACCRUFER ferric maltol CAPSULE;ORAL 212320-001 Jul 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Shield Tx ACCRUFER ferric maltol CAPSULE;ORAL 212320-001 Jul 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

Country Patent Number Title Estimated Expiration
Japan 2017501235 トリマルトール鉄(III)の投与計画 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009138761 ⤷  Try a Trial
Slovenia 3091974 ⤷  Try a Trial
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) ⤷  Try a Trial
United Kingdom 201400171 ⤷  Try a Trial
Japan 2017535510 マルトール第二鉄の結晶形態 ⤷  Try a Trial
China 107001310 麦芽酚铁的结晶形式 (Crystalline forms of ferric maltol) ⤷  Try a Trial
>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.