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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Fuji
Chinese Patent Office
UBS
Cipla
Julphar
Farmers Insurance
Queensland Health
Harvard Business School

Generated: April 19, 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: 23
Clinical Trials: 26
Patent Applications: 26
Drug Prices:see low prices
DailyMed Link:fidaxomicin at DailyMed
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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
8,728,796 Tiacumicin production ➤ Try a Free Trial
8,883,986 Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof ➤ Try a Free Trial
7,507,564 Tiacumicin production ➤ Try a Free Trial
8,518,899 Macrocyclic polymorphs, compositions comprising such polymorphs and methods of use and manufacture thereof ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for fidaxomicin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000026 Germany ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
00727 Netherlands ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
15/019 Ireland ➤ Try a Free Trial 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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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
US Army
Queensland Health
Fish and Richardson
Dow
Teva
Cipla
McKesson
Fuji

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.