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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
US Department of Justice
Harvard Business School
Express Scripts
McKesson
Mallinckrodt
Chubb
Healthtrust

Generated: August 18, 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. One supplier is listed for this compound.

Pharmacology for fidaxomicin
Ingredient-typeMacrolides
Drug ClassMacrolide Antibacterial
Synonyms for fidaxomicin
(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
AB01566930_01
AC-27766
AKOS025401984
AOB87327
BC600591
BRN 5228707
CA012210
CHEBI:68590
CHEMBL1255800
Clostomicin B1
Clostomycin B1
CS-3249
D06LNW
D09394
DB08874
Dificid
Dificid (TN)
Dificlir
Dificlir (TN)
Difimicin
Fidaxomicin (Dificid)
Fidaxomicin (JAN/USAN)
Fidaxomicin [USAN:INN]
Fidaxomicin, >=98% (HPLC)
fidaxomicin/Dificid
HY-17580
Lipiarmicin
Lipiarmycin
Lipiarmycin A 3
Lipiarmycin A3
Lipiarrmycin
MolPort-035-395-799
OPT 80
OPT-80
PAR 01
PAR 101
PAR-101
R-Tiacumicin B
RTECS OQ7378000
S-7827
S4227
SCHEMBL10000818
Tiacumicin B
UNII-Z5N076G8YQ
Z5N076G8YQ

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 ➤ 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
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
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
8,518,899 Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof ➤ Sign Up
8,728,796 Tiacumicin production ➤ 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 fidaxomicin

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
0150013 00220 Estonia ➤ Sign Up PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
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
0727 Netherlands ➤ Sign Up PRODUCT NAME: FIDAXOMICINE; 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Mallinckrodt
Citi
Colorcon
Teva
Julphar
US Department of Justice
McKesson
Fish and Richardson

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.