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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 203565


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NDA 203565 describes INJECTAFER, which is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the INJECTAFER profile page.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.
Summary for 203565
Tradename:INJECTAFER
Applicant:Am Regent
Ingredient:ferric carboxymaltose
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203565
Generic Entry Date for 203565*:
Constraining patent/regulatory exclusivity:
TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
Dosage:
INJECTABLE;INTRAVENOUS

*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: 203565
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 203565
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565 NDA American Regent, Inc. 0517-0602 0517-0602-01 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE
INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565 NDA American Regent, Inc. 0517-0620 0517-0620-01 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength750MG IRON/15ML (50MG IRON/ML)
Approval Date:Jul 25, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 19, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:May 31, 2026
Regulatory Exclusivity Use:TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY
Patent:⤷  Sign UpPatent Expiration:Jan 8, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD TO TREAT IRON DEFICIENCY IN ADULTS WEIGHING AT LEAST 40 KG WITH HEART FAILURE & NY HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST ABOUT 0.6 G OF ELEMENTAL IRON

Expired US Patents for NDA 203565

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 ⤷  Sign Up ⤷  Sign Up
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-002 Oct 8, 2020 ⤷  Sign Up ⤷  Sign Up
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 ⤷  Sign Up ⤷  Sign Up
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 ⤷  Sign Up ⤷  Sign Up
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-001 Jul 25, 2013 ⤷  Sign Up ⤷  Sign Up
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-004 Feb 4, 2022 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.