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. One supplier is listed 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
Summary for ACCRUFER
International Patents: | 50 |
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 |


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
Sponsor | Phase |
---|---|
Shield Therapeutics | Phase 1 |
Pharmacology for ACCRUFER
Drug Class | Parenteral Iron Replacement Phosphate Binder |
Mechanism of Action | Phosphate Chelating Activity |
Anatomical Therapeutic Chemical (ATC) Classes 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
Israel
Patent: 1863
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: 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 |
---|---|---|---|
Japan | 2018197268 | マルトール第二鉄の結晶形態 (CRYSTAL FORM OF FERRIC MALTOL) | ⤷ Try a Trial |
China | 107001310 | 麦芽酚铁的结晶形式 (Crystalline forms of ferric maltol) | ⤷ Try a Trial |
Saudi Arabia | 517381406 | صور بلورية من مالتول الحديديك (Crystalline Forms of Ferric Maltol) | ⤷ Try a Trial |
South Korea | 20170071446 | 제2철 말톨의 결정질 형태 (2 CRYSTALLINE FORMS OF FERRIC MALTOL) | ⤷ Try a Trial |
United Kingdom | 0808835 | ⤷ Try a Trial | |
Canada | 2934836 | SCHEMA POSOLOGIQUE DE TRIMALTOL FERRIQUE (DOSAGE REGIMEN OF FERRIC TRIMALTOL) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |