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Serving leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
Chinese Patent Office
McKesson
US Department of Justice
UBS
Cantor Fitzgerald
Covington
Johnson and Johnson
Mallinckrodt

Generated: January 17, 2018

DrugPatentWatch Database Preview

DIFICID Drug Profile

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Which patents cover Dificid, and when can generic versions of Dificid launch?

Dificid is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in twenty-five countries.

The generic ingredient in DIFICID is fidaxomicin. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.
Summary for DIFICID
International Patents:101
US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 27
Clinical Trials: 9
Patent Applications: 23
Drug Prices:see details
DailyMed Link:DIFICID at DailyMed
Drug patent expirations by year for DIFICID
Pharmacology for DIFICID
Ingredient-typeMacrolides
Drug ClassMacrolide Antibacterial

US Patents and Regulatory Information for DIFICID

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 ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Paragraph IV (Patent) Challenges for DIFICID
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 200 mg ➤ Subscribe 5/27/2015

Non-Orange Book US Patents for DIFICID

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 ➤ Subscribe
8,518,899 Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof ➤ Subscribe
8,883,986 Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof ➤ Subscribe
8,728,796 Tiacumicin production ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for DIFICID

Supplementary Protection Certificates for DIFICID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00727 Netherlands ➤ Subscribe PRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
15/019 Ireland ➤ Subscribe PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
/2015 Austria ➤ Subscribe PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
0150013 00220 Estonia ➤ Subscribe PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
1539977/01 Switzerland ➤ Subscribe PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014
C0028 France ➤ Subscribe PRODUCT NAME: FIDAXOMICINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
2015 00020 Denmark ➤ Subscribe PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
2015000026 Germany ➤ Subscribe PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
0727 Netherlands ➤ Subscribe PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
2015 00020 Denmark ➤ Subscribe PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Argus Health
Deloitte
Boehringer Ingelheim
Colorcon
Cantor Fitzgerald
US Department of Justice
Teva
US Army
McKinsey

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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