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Last Updated: September 28, 2020

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Fidaxomicin - Generic Drug Details

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What are the generic drug sources for fidaxomicin and what is the scope of patent protection?

Fidaxomicin is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in two NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fidaxomicin has one hundred and fifty-two patent family members in thirty-four countries.

There are two drug master file entries for fidaxomicin. One supplier is listed for this compound.

Recent Clinical Trials for fidaxomicin

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

SponsorPhase
Todd LeePhase 4
Canadian Institutes of Health Research (CIHR)Phase 4
University of ManitobaPhase 2

See all fidaxomicin clinical trials

Pharmacology for fidaxomicin
Paragraph IV (Patent) Challenges for FIDAXOMICIN
Tradename Dosage Ingredient NDA Submissiondate
DIFICID TABLET;ORAL fidaxomicin 201699 2015-05-27

US Patents and Regulatory Information for fidaxomicin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 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

Supplementary Protection Certificates for fidaxomicin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539977 C201530022 Spain   Start Trial PRODUCT NAME: FIDAXOMICINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001-004; DATE OF AUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20111207
1539977 C 2015 015 Romania   Start Trial PRODUCT NAME: FIDAXOMICIN; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF NATIONAL AUTHORISATION: 20111205; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF FIRST AUTHORISATION IN EEA: 20111205
1539977 300727 Netherlands   Start Trial PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
1539977 15C0028 France   Start Trial PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Dow

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