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Last Updated: August 8, 2020

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INJECTAFER Drug Profile

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When do Injectafer patents expire, and when can generic versions of Injectafer launch?

Injectafer is a drug marketed by Am Regent and is included in one NDA. There are five patents protecting this drug.

This drug has seventy patent family members in thirty-two countries.

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.

US ANDA Litigation and Generic Entry Outlook for Injectafer

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 5, 2024. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for INJECTAFER
Drug Prices for INJECTAFER

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Generic Entry Opportunity Date for INJECTAFER
Generic Entry Date for INJECTAFER*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for INJECTAFER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Heart, Lung, and Blood Institute (NHLBI)Phase 3
Baylor College of MedicinePhase 3
SandozPhase 1

See all INJECTAFER clinical trials

Pharmacology for INJECTAFER
Paragraph IV (Patent) Challenges for INJECTAFER
Tradename Dosage Ingredient NDA Submissiondate
INJECTAFER INJECTABLE;INTRAVENOUS ferric carboxymaltose 203565 2019-03-27

US Patents and Regulatory Information for INJECTAFER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Am Regent INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Am Regent INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Am Regent INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Am Regent INJECTAFER ferric carboxymaltose INJECTABLE;INTRAVENOUS 203565-001 Jul 25, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   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:

Baxter
McKesson
Boehringer Ingelheim
McKinsey
Mallinckrodt
Colorcon

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