Ferric maltol - Generic Drug Details
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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
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
Sponsor | Phase |
---|---|
Norgine | Phase 4 |
Radboud University Medical Center | Phase 4 |
Leiden University Medical Center | Phase 4 |
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
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 | ⤷ 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 | ||||
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
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 | ⤷ Sign Up |
Japan | 6556753 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2009138761 | ⤷ Sign Up | |
Canada | 2944210 | FORMES CRISTALLINES DE MALTOL FERRIQUE (CRYSTALLINE FORMS) | ⤷ Sign Up |
Canada | 2724172 | COMPOSITIONS MONOCOMPOSE (D' HYDROXYPYRONE DE FER) ET DE COMBINAISON (D'HYDROXYPYRONE DE FER ET D'AGENTS INHIBITEURS D'INFLAMMATION GASTRO-INTESTINALES) POUR LUTTER CONTRE L'ANEMIE 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 |
China | 107001310 | 麦芽酚铁的结晶形式 (Crystalline forms of ferric maltol) | ⤷ Sign Up |
Japan | 2011520855 | ⤷ 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.