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McKinsey
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Colorcon
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Covington
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Generated: August 22, 2018

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DIFICID Drug Profile

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When do Dificid patents expire, and what generic alternatives are available?

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. One supplier is listed for this compound. Additional details are available on the fidaxomicin profile page.

Drug patent expirations by year for DIFICID
Generic Entry Opportunity Date for DIFICID
Generic Entry Date for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for DIFICID
Ingredient-typeMacrolides
Drug ClassMacrolide Antibacterial
Synonyms for DIFICID
(2R,3S,4S,5S,6R)-6-{[(3E,5E,8S,9E,11S,12R,13E,15E,18S)-12-{[(2R,3S,4R,5S)-3,4-dihydroxy-6,6-dimethyl-5-[(2-methylpropanoyl)oxy]oxan-2-yl]oxy}-11-ethyl-8-hydroxy-18-[(1R)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctad
55352-58-4
56645-60-4
750595-89-2
873857-62-6
BRN 5228707
CHEMBL1255800
Clostomicin B1
Clostomycin B1
D06LNW
Dificid (TN)
Dificlir
Difimicin
Fidaxomicin
Fidaxomicin (Dificid)
Fidaxomicin [USAN:INN]
Fidaxomicin, >=98% (HPLC)
fidaxomicin/Dificid
Lipiarmicin
Lipiarmycin
Lipiarmycin A 3
Lipiarmycin A3
OPT-80
PAR 01
PAR-101
R-Tiacumicin B
RTECS OQ7378000
S-7827
SCHEMBL10000818
Tiacumicin B
UNII-Z5N076G8YQ
Z5N076G8YQ

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 ➤ 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
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
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 Date
➤ Subscribe Tablets 200 mg ➤ Subscribe ➤ Sign Up

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

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Supplementary Protection Certificates for DIFICID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00020 Denmark ➤ Sign Up PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
15/019 Ireland ➤ Sign Up PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977/01 Switzerland ➤ Sign Up PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: SWISSMEDIC 62957 01.05.2014
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
2015 00020 Denmark ➤ Sign Up PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
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:

McKinsey
Chubb
Colorcon
Julphar
AstraZeneca
Covington
McKesson
Boehringer Ingelheim
Federal Trade Commission

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