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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212320


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NDA 212320 describes ACCRUFER, which is a drug marketed by Shield Tx and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ACCRUFER profile page.

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.
Summary for 212320
Tradename:ACCRUFER
Applicant:Shield Tx
Ingredient:ferric maltol
Patents:3
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212320
Generic Entry Date for 212320*:
Constraining patent/regulatory exclusivity:
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.

Pharmacology for NDA: 212320
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 212320
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACCRUFER ferric maltol CAPSULE;ORAL 212320 NDA Shield TX (UK) Ltd 73059-001 73059-001-10 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-10) / 10 CAPSULE in 1 BOTTLE, PLASTIC
ACCRUFER ferric maltol CAPSULE;ORAL 212320 NDA Shield TX (UK) Ltd 73059-001 73059-001-60 1 BOTTLE, PLASTIC in 1 CARTON (73059-001-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG IRON
Approval Date:Jul 25, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 25, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Jan 6, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING IRON DEFICIENCY
Patent:⤷  Sign UpPatent Expiration:Mar 29, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING IRON DEFICIENCY

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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.