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Last Updated: April 17, 2024

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ACCRUFER Drug Patent Profile


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Which patents cover Accrufer, and when can generic versions of Accrufer launch?

Accrufer is a drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-one patent family members in nineteen countries.

The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric maltol profile page.

DrugPatentWatch® Generic Entry Outlook for Accrufer

Accrufer was eligible for patent challenges on July 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 23, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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  Try a Trial

Summary for ACCRUFER
International Patents:51
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
Drug Prices: Drug price information for ACCRUFER
What excipients (inactive ingredients) are in ACCRUFER?ACCRUFER excipients list
DailyMed Link:ACCRUFER at DailyMed
Drug patent expirations by year for ACCRUFER
Drug Prices for ACCRUFER

See drug prices for ACCRUFER

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACCRUFER
Generic Entry Date for ACCRUFER*:
Constraining patent/regulatory exclusivity:
NDA:
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 ACCRUFER

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

SponsorPhase
Shield TherapeuticsPhase 1

See all ACCRUFER clinical trials

Pharmacology for ACCRUFER

US Patents and Regulatory Information for ACCRUFER

ACCRUFER is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ACCRUFER is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ACCRUFER

Dosage regimen of ferric trimaltol
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY

Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY

Crystalline forms of ferric maltol
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRON DEFICIENCY

FDA Regulatory Exclusivity protecting ACCRUFER

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  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
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 ACCRUFER

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 ACCRUFER

When does loss-of-exclusivity occur for ACCRUFER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15340825
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017008903
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 44210
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 17001030
Estimated Expiration: ⤷  Try a Trial

China

Patent: 7001310
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 3323
Estimated Expiration: ⤷  Try a Trial

Patent: 1790667
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 60951
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 04358
Estimated Expiration: ⤷  Try a Trial

Patent: 78711
Estimated Expiration: ⤷  Try a Trial

Patent: 17535510
Estimated Expiration: ⤷  Try a Trial

Patent: 18197268
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 0730
Estimated Expiration: ⤷  Try a Trial

Patent: 17005413
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 60951
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 7381406
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201702639R
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1702136
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2576930
Estimated Expiration: ⤷  Try a Trial

Patent: 170071446
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 61944
Estimated Expiration: ⤷  Try a Trial

United Kingdom

Patent: 31742
Estimated Expiration: ⤷  Try a Trial

Patent: 1419174
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ACCRUFER around the world.

Country Patent Number Title Estimated Expiration
United Kingdom 0808835 ⤷  Try a Trial
Japan 2015083572 鉄ヒドロキシピロンを含む薬剤組成物 (PHARMACEUTICAL COMPOSITION COMPRISING IRON HYDROXYPYRONE) ⤷  Try a Trial
Canada 2934836 SCHEMA POSOLOGIQUE DE TRIMALTOL FERRIQUE (DOSAGE REGIMEN OF FERRIC TRIMALTOL) ⤷  Try a Trial
Mexico 370730 FORMAS CRISTALINAS DE MALTOL FÉRRICO. (CRYSTALLINE FORMS OF FERRIC MALTOL.) ⤷  Try a Trial
Japan 6678711 ⤷  Try a Trial
Eurasian Patent Organization 201790667 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА ⤷  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
>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.