Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Harvard Business School

Last Updated: November 17, 2019

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Ferric carboxymaltose - Generic Drug Details

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What are the generic sources for ferric carboxymaltose and what is the scope of patent protection?

Ferric carboxymaltose is the generic ingredient in one branded drug marketed by Am Regent and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric carboxymaltose has seventy patent family members in thirty-two countries.

There are twenty drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.

Recent Clinical Trials for ferric carboxymaltose

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SponsorPhase
Kepler University HospitalPhase 4
Asociación Instituto de Investigación Sanitaria BioCrucesPhase 4
Konkuk University Medical CenterPhase 4

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Recent Litigation for ferric carboxymaltose

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District Court Litigation
Case NameDate
VIFOR (INTERNATIONAL) AG v. SANDOZ INC.2019-08-02
VIFOR (INTERNATIONAL) AG v. MYLAN LABORATORIES LTD.2019-06-18

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PTAB Litigation
PetitionerDate
Pharmacosmos A/S2015-06-24

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

US Patents and Regulatory Information for ferric carboxymaltose

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 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   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:

Medtronic
McKesson
AstraZeneca
Dow
Boehringer Ingelheim
Mallinckrodt

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