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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Teva
QuintilesIMS
Accenture
Healthtrust
Dow
Medtronic
Baxter
Chinese Patent Office

Generated: December 11, 2017

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Fidaxomicin - Generic Drug Details

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

Fidaxomicin
is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in one NDA. There are five 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 one patent family members in twenty-five countries and ten supplementary protection certificates in eight countries.

There are two drug master file entries for fidaxomicin. Two suppliers are listed for this compound.

Summary for fidaxomicin

Pharmacology for fidaxomicin

Ingredient-typeMacrolides
Drug ClassMacrolide Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms LlcDIFICIDfidaxomicinTABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Cubist Pharms LlcDIFICIDfidaxomicinTABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Cubist Pharms LlcDIFICIDfidaxomicinTABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Cubist Pharms LlcDIFICIDfidaxomicinTABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Cubist Pharms LlcDIFICIDfidaxomicinTABLET;ORAL201699-001May 27, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: fidaxomicin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,507,564Tiacumicin production► Subscribe
8,883,986Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof► Subscribe
8,728,796Tiacumicin production► Subscribe
8,518,899Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fidaxomicin

Country Document Number Estimated Expiration
Canada2676061► Subscribe
Taiwan200840562► Subscribe
World Intellectual Property Organization (WIPO)2008091554► Subscribe
South Korea101399621► Subscribe
TaiwanI425942► Subscribe
SloveniaEP2070530► Subscribe
China1688707► Subscribe
Japan2007537290► Subscribe
Japan5764168► Subscribe
European Patent Office1940417► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FIDAXOMICIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00727Netherlands► SubscribePRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977/01Switzerland► SubscribePRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014
/2015Austria► SubscribePRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
0727Netherlands► SubscribePRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
684Luxembourg► SubscribePRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207
2015 00020Denmark► SubscribePRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
2015000026Germany► SubscribePRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
2015 00020Denmark► SubscribePRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
C0028France► SubscribePRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
15/019Ireland► SubscribePRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
Boehringer Ingelheim
Queensland Health
Argus Health
Covington
Mallinckrodt
Merck
AstraZeneca
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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