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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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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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACCRUFER

Generic Entry Date for ACCRUFER^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 212320 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

Sponsor	Phase
Shield Therapeutics	Phase 1

See all ACCRUFER clinical trials

Pharmacology for ACCRUFER

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY

Crystalline forms of ferric maltol
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRON DEFICIENCY

FDA Regulatory Exclusivity protecting ACCRUFER

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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				⤷ 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
>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

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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 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
Patent: Crystalline forms of ferric maltol
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2017008903
Patent: formas cristalinas de maltol férrico
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 44210
Patent: FORMES CRISTALLINES DE MALTOL FERRIQUE (CRYSTALLINE FORMS)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 17001030
Patent: Formas cristalinas de maltol férrico
Estimated Expiration: ⤷ Sign Up

China

Patent: 7001310
Patent: 麦芽酚铁的结晶形式 (Crystalline forms of ferric maltol)
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 3323
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА (CRYSTALLINE FORMS OF FERRIC MALTOL)
Estimated Expiration: ⤷ Sign Up

Patent: 1790667
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 60951
Patent: FORMES CRISTALLINES DE MALTOL FERRIQUE (CRYSTALLINE FORMS OF FERRIC MALTOL)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 04358
Estimated Expiration: ⤷ Sign Up

Patent: 78711
Estimated Expiration: ⤷ Sign Up

Patent: 17535510
Patent: マルトール第二鉄の結晶形態
Estimated Expiration: ⤷ Sign Up

Patent: 18197268
Patent: マルトール第二鉄の結晶形態 (CRYSTAL FORM OF FERRIC MALTOL)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 0730
Patent: FORMAS CRISTALINAS DE MALTOL FÉRRICO. (CRYSTALLINE FORMS OF FERRIC MALTOL.)
Estimated Expiration: ⤷ Sign Up

Patent: 17005413
Patent: FORMAS CRISTALINAS DE MALTOL FERRICO. (CRYSTALLINE FORMS OF FERRIC MALTOL.)
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 60951
Estimated Expiration: ⤷ Sign Up

Saudi Arabia

Patent: 7381406
Patent: صور بلورية من مالتول الحديديك (Crystalline Forms of Ferric Maltol)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201702639R
Patent: CRYSTALLINE FORMS OF FERRIC MALTOL
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1702136
Patent: CRYSTALLINE FORMS OF FERRIC MALTOL
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2576930
Estimated Expiration: ⤷ Sign Up

Patent: 170071446
Patent: 제2철 말톨의 결정질 형태 (2 CRYSTALLINE FORMS OF FERRIC MALTOL)
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 61944
Estimated Expiration: ⤷ Sign Up

United Kingdom

Patent: 31742
Patent: Crystalline forms
Estimated Expiration: ⤷ Sign Up

Patent: 1419174
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Japan	2017501235	トリマルトール鉄（ＩＩＩ）の投与計画	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016066555		⤷ Sign Up
Japan	2019131592	トリマルトール鉄（ＩＩＩ）の投与計画 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)	⤷ Sign Up
Poland	3160951		⤷ Sign Up
South Africa	201702136	CRYSTALLINE FORMS OF FERRIC MALTOL	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration