Fidaxomicin - Generic Drug Details

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What are the generic sources for fidaxomicin and what is the scope of freedom to operate?

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-seven patent family members in thirty-six countries.

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

Summary for fidaxomicin

International Patents:	157
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	35
Patent Applications:	1,884
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

See drug prices for fidaxomicin

Recent Clinical Trials for fidaxomicin

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

Sponsor	Phase
Benoit Guery	Phase 3
Hellenic Institute for the Study of Sepsis	Phase 2
OLVG	Phase 4

See all fidaxomicin clinical trials

Pharmacology for fidaxomicin

Drug Class	Macrolide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for fidaxomicin

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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

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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

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Country	Patent Number	Title	Estimated Expiration
Denmark	2305244		⤷ Sign Up
European Patent Office	2305244	Traitement de maladies consecutives a un traitement antibiotique (Treatment of diseases associated with the use of antibiotics)	⤷ Sign Up
Eurasian Patent Organization	030049	ПРИМЕНЕНИЕ ЭКСЦИПИЕНТА В КАЧЕСТВЕ ПРОТИВОВСПЕНИВАЮЩЕЙ ДОБАВКИ В КОМПОЗИЦИИ, СОДЕРЖАЩЕЙ ТИАКУМИЦИНОВОЕ СОЕДИНЕНИЕ (USE OF AN EXCIPIENT AS AN ANTI-FOAMING AGENT IN A COMPOSITION COMPRISING A TIACUMICIN COMPOUND)	⤷ Sign Up
Japan	2013241440	MACROLIDE POLYMORPHS, COMPOSITIONS COMPRISING SUCH POLYMORPHS, AND METHODS OF USE AND FOR PRODUCTION THEREOF	⤷ Sign Up
Georgia, Republic of	P201706769	COMPOSITION OF TIACUMICIN COMPOUNDS	⤷ Sign Up
Poland	2125850		⤷ Sign Up
Australia	2005327308	18-membered macrocycles and analogs thereof	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for fidaxomicin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	15C0028	France	⤷ Sign Up	PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
1539977	585	Finland	⤷ Sign Up
1539977	122015000026	Germany	⤷ Sign Up	PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977	C201530022	Spain	⤷ Sign Up	PRODUCT NAME: FIDAXOMICINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001-004; DATE OF AUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20111207
1539977	CA 2015 00020	Denmark	⤷ Sign Up	PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
1539977	366 50006-2015	Slovakia	⤷ Sign Up	OWNER(S): MERCK SHARP & DOHME LLC, RAHWAY, NJ, US; PREDCHADZAJUCI MAJITEL: MERCK SHARP & DOHME CORP., RAHWAY, NJ, US; DATUM ZAPISU DO REGISTRA: 7.10.2022
1539977	C20150013 00220	Estonia	⤷ Sign Up	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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