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Last Updated: March 28, 2024

FIDAXOMICIN Drug Patent Profile


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When do Fidaxomicin patents expire, and what generic alternatives are available?

Fidaxomicin is a drug marketed by Actavis Labs Fl and is included in one NDA.

The generic ingredient in FIDAXOMICIN is fidaxomicin. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fidaxomicin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fidaxomicin

A generic version of FIDAXOMICIN was approved as fidaxomicin by ACTAVIS LABS FL on January 16th, 2024.

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Drug patent expirations by year for FIDAXOMICIN
Drug Prices for FIDAXOMICIN

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Recent Clinical Trials for FIDAXOMICIN

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SponsorPhase
Hellenic Institute for the Study of SepsisPhase 2
Benoit GueryPhase 3
Leiden University Medical CenterPhase 4

See all FIDAXOMICIN clinical trials

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
Actavis Labs Fl FIDAXOMICIN fidaxomicin TABLET;ORAL 208443-001 Jan 16, 2024 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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