~ Buy the ACCRUFER (ferric maltol) Drug Profile, 2024 PDF Report in the Report Store ~

ACCRUFER Drug Patent Profile

✉ Email this page to a colleague

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

< Available with Subscription >

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

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

Generic Entry Date for ACCRUFER^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Anatomical Therapeutic Chemical (ATC) Classes for ACCRUFER

B03AB	Iron trivalent, oral preparations
B03A	IRON PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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

Subscribe to access the full database, or Try a Trial
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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Japan	2018197268	マルトール第二鉄の結晶形態 (CRYSTAL FORM OF FERRIC MALTOL)	⤷ Try a Trial
Japan	5769308		⤷ Try a Trial
Israel	246613	משטר מינון של ברזל טרימלטול (Dosage regimen of ferric trimaltol)	⤷ Try a Trial
China	114010629	三麦芽酚铁的剂量方案 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)	⤷ Try a Trial
Eurasian Patent Organization	033323	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА (CRYSTALLINE FORMS OF FERRIC MALTOL)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration