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Last Updated: July 16, 2020

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ACCRUFER Drug 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 forty-five patent family members in seventeen 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.

US ANDA Litigation and 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:45
US Patents:3
Applicants:1
NDAs:1
DailyMed Link:ACCRUFER at DailyMed
Drug patent expirations by year for ACCRUFER
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.

US Patents and Regulatory Information for ACCRUFER

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Medtronic
Merck
McKinsey
Moodys

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.