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Boehringer Ingelheim

Last Updated: August 7, 2020

DrugPatentWatch Database Preview

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 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
Canadian Institutes of Health Research (CIHR)Phase 4
Todd LeePhase 4
University of CalgaryPhase 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 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   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 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
>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 300727 Netherlands   Start Trial PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
1539977 122015000026 Germany   Start Trial PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977 16/2015 Austria   Start Trial PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
1539977 C20150013 00220 Estonia   Start Trial PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Merck
McKesson
Express Scripts
Medtronic

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