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Serving hundreds of leading biopharmaceutical companies globally:

Teva
McKinsey
Farmers Insurance
Colorcon
Argus Health
Harvard Business School
Queensland Health
Chubb
Cantor Fitzgerald

Generated: May 24, 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.
Drug patent expirations by year for DIFICID
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
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 2015-05-27

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
8,728,796 Tiacumicin production ➤ Sign Up
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
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for DIFICID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0150013 00220 Estonia ➤ Sign Up PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
/2015 Austria ➤ Sign Up PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
McKesson
Cipla
Moodys
Fuji
US Department of Justice
UBS
Teva

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.