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Last Updated: March 18, 2024

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 two branded drugs marketed by Cubist Pharms Llc and Actavis Labs Fl, and is included in three 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-seven patent family members in thirty-six countries.

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

Drug Prices for fidaxomicin

See drug prices for fidaxomicin

Recent Clinical Trials for fidaxomicin

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

SponsorPhase
Hellenic Institute for the Study of SepsisPhase 2
Benoit GueryPhase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 4

See all fidaxomicin clinical trials

Pharmacology for fidaxomicin
Paragraph IV (Patent) Challenges for FIDAXOMICIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIFICID Tablets fidaxomicin 200 mg 201699 1 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 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for fidaxomicin

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Tillotts Pharma GmbH Dificlir fidaxomicin EMEA/H/C/002087
Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Authorised no no no 2011-12-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for fidaxomicin

Country Patent Number Title Estimated Expiration
South Africa 200905337 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof ⤷  Try a Trial
European Patent Office 2070530 Traitement de maladies consecutives a un traitement antibiotique (Treatment of diseases associated with the use of antibiotics) ⤷  Try a Trial
Taiwan I453015 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for fidaxomicin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539977 2015C/017 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1539977 C20150013 00220 Estonia ⤷  Try a Trial PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
1539977 C 2015 015 Romania ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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