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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
US Department of Justice
Express Scripts
Farmers Insurance
Johnson and Johnson
Daiichi Sankyo
Chubb
Covington

Generated: December 13, 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
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 ➤ 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 ➤ 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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Paragraph IV (Patent) Challenges for DIFICID
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 200 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for DIFICID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
0727 Netherlands ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
90020-2 Sweden ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733 20111205
2015 00020 Denmark ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
2015 00020 Denmark ➤ Try a Free Trial PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. 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:

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

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.