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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ACCRUFER
*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 |
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
| 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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| United Kingdom | 201400171 | ⤷ Sign Up | |
| Spain | 2661944 | ⤷ Sign Up | |
| United Kingdom | 201419174 | ⤷ Sign Up | |
| Japan | 2011520855 | ⤷ Sign Up | |
| United Kingdom | 0808835 | ⤷ Sign Up | |
| 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) | ⤷ Sign Up |
| South Korea | 102351422 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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