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Last Updated: May 25, 2022

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 patent family members in nineteen countries.

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

DrugPatentWatch® Generic Entry Outlook for Accrufer

Accrufer will be eligible for patent challenges on July 25, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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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Summary for ACCRUFER
International Patents:50
US Patents:3
Applicants:1
NDAs:1
Clinical Trials: 1
What excipients (inactive ingredients) are in ACCRUFER?ACCRUFER excipients list
DailyMed Link:ACCRUFER at DailyMed
Drug patent expirations by year for ACCRUFER
DrugPatentWatch® Estimated Generic Entry Opportunity 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

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRON DEFICIENCY

Crystalline forms of ferric maltol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRON DEFICIENCY

FDA Regulatory Exclusivity protecting ACCRUFER

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

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: See Plans and Pricing

Brazil

Patent: 2017008903
Estimated Expiration: See Plans and Pricing

Canada

Patent: 44210
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17001030
Estimated Expiration: See Plans and Pricing

China

Patent: 7001310
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 3323
Estimated Expiration: See Plans and Pricing

Patent: 1790667
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 60951
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1863
Estimated Expiration: See Plans and Pricing

Japan

Patent: 04358
Estimated Expiration: See Plans and Pricing

Patent: 78711
Estimated Expiration: See Plans and Pricing

Patent: 17535510
Estimated Expiration: See Plans and Pricing

Patent: 18197268
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 0730
Estimated Expiration: See Plans and Pricing

Patent: 17005413
Estimated Expiration: See Plans and Pricing

Poland

Patent: 60951
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 7381406
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201702639R
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1702136
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170071446
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61944
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 31742
Estimated Expiration: See Plans and Pricing

Patent: 1419174
Estimated Expiration: See Plans and Pricing

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
Japan 2017501235 トリマルトール鉄(III)の投与計画 See Plans and Pricing
China 114010629 三麦芽酚铁的剂量方案 See Plans and Pricing
Japan 2015083572 鉄ヒドロキシピロンを含む薬剤組成物 (PHARMACEUTICAL COMPOSITION COMPRISING IRON HYDROXYPYRONE) See Plans and Pricing
>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.