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Fidaxomicinis 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-eight patent family members in thirty-five countries.
There are two drug master file entries for fidaxomicin. One supplier is listed for this compound.
Summary for fidaxomicin
|Drug Master File Entries:||2|
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||44|
|Drug Prices:||Drug price trends for fidaxomicin|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for fidaxomicin|
|What excipients (inactive ingredients) are in fidaxomicin?||fidaxomicin excipients list|
|DailyMed Link:||fidaxomicin at DailyMed|
Recent Clinical Trials for fidaxomicin
Identify potential brand extensions & 505(b)(2) entrants
|Artugen Therapeutics USA, Inc.||Phase 1|
|Canadian Institutes of Health Research (CIHR)||Phase 4|
|Todd Lee||Phase 4|
Pharmacology for fidaxomicin
|Drug Class||Macrolide Antibacterial |
|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||⤷ Try it Free||⤷ Try it Free||Y||⤷ Try it Free|
|Cubist Pharms Llc||DIFICID||fidaxomicin||TABLET;ORAL||201699-001||May 27, 2011||RX||Yes||Yes||⤷ Try it Free||⤷ Try it Free||Y||⤷ Try it Free|
|Cubist Pharms Llc||DIFICID||fidaxomicin||FOR SUSPENSION;ORAL||213138-001||Jan 24, 2020||RX||Yes||Yes||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1539977||92684||Luxembourg||⤷ Try it Free||PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/733/001-002-004 - DIFICLIR|
|1539977||C 2015 015||Romania||⤷ Try it Free||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||16/2015||Austria||⤷ Try it Free||PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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