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Last Updated: February 2, 2023

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-nine 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

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Recent Clinical Trials for fidaxomicin

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SponsorPhase
Benoit GueryPhase 3
Hellenic Institute for the Study of SepsisPhase 2
OLVGPhase 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 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Supplementary Protection Certificates for fidaxomicin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539977 1590020-2 Sweden See Plans and Pricing PRODUCT NAME: FIDAXOMICIN; TOTAL VALIDITY PERIOD: 16 JULY 2023 THROUGH 6 JUNE 2027
1539977 SPC/GB15/020 United Kingdom See Plans and Pricing PRODUCT NAME: FIDAXOMICIN; REGISTERED: UK EU/1/11/733/001 20111207; UK EU/1/11/733/002 20111207; UK EU/1/11/733/003 20111207; UK EU/1/11/733/004 20111207
1539977 C01539977/01 Switzerland See Plans and Pricing FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US
1539977 C300727 Netherlands See Plans and Pricing PRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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