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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
QuintilesIMS
Queensland Health
Cantor Fitzgerald
Chubb
Dow
Julphar
Accenture
Fuji

Generated: February 25, 2018

DrugPatentWatch Database Preview

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.

There are two drug master file entries for fidaxomicin. Two suppliers are listed for this compound.
Summary for fidaxomicin
International Patents:101
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Suppliers / Packagers: 2
Bulk Api Vendors: 26
Clinical Trials: 26
Patent Applications: 26
Drug Prices:see low prices
DailyMed Link:fidaxomicin at DailyMed
Pharmacology for fidaxomicin
Ingredient-typeMacrolides
Drug ClassMacrolide Antibacterial

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ 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 TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,507,564 Tiacumicin production ➤ Sign Up
8,883,986 Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof ➤ Sign Up
8,518,899 Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof ➤ Sign Up
8,728,796 Tiacumicin production ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for fidaxomicin

Country Document Number Estimated Expiration
Japan 2007537290 ➤ Sign Up
New Zealand 578697 ➤ Sign Up
Brazil PI0806878 ➤ Sign Up
Australia 2008209580 ➤ Sign Up
Japan 5468388 ➤ Sign Up
China 100519757 ➤ Sign Up
South Korea 101399621 ➤ Sign Up
Canada 2626698 ➤ Sign Up
Canada 2880860 ➤ Sign Up
China 101340919 ➤ Sign Up
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for fidaxomicin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0150013 00220 Estonia ➤ Sign Up PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
2015000026 Germany ➤ Sign Up PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
2015 00020 Denmark ➤ Sign Up PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
684 Luxembourg ➤ Sign Up PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207
C0028 France ➤ Sign Up PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
15/019 Ireland ➤ Sign Up PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
2015 00020 Denmark ➤ Sign Up PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
/2015 Austria ➤ Sign Up PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
1539977/01 Switzerland ➤ Sign Up PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014
0727 Netherlands ➤ Sign Up PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Julphar
Cantor Fitzgerald
US Army
Teva
Fuji
Deloitte
Fish and Richardson
Johnson and Johnson

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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