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Last Updated: June 3, 2020

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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 two NDAs. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-nine patent family members in thirty-four 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.

US ANDA Litigation and Generic Entry Outlook for Dificid

Dificid was eligible for patent challenges on May 27, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 31, 2028. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DIFICID
Drug Prices for DIFICID

See drug prices for DIFICID

Generic Entry Opportunity Date for DIFICID
Generic Entry Dates for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL
Generic Entry Dates for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;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.

Recent Clinical Trials for DIFICID

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of AlbertaPhase 2
McMaster UniversityPhase 3
Astellas Pharma Europe B.V.Phase 3

See all DIFICID clinical trials

Recent Litigation for DIFICID

Identify potential future generic entrants

District Court Litigation
Case NameDate
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2020-01-16
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.2015-08-31
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.

See all DIFICID litigation

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-oxacycloocta
873857-62-6
BRN 5228707
CHEMBL1255800
Clostomicin B1
Clostomycin B1
DB08874
Dificlir
Difimicin
FI8
Fidaxomicin
Fidaxomicin [USAN:INN]
Fidaxomicin, >=98% (HPLC)
fidaxomicin/Dificid
Lipiarmicin
Lipiarmycin
Lipiarmycin A 3
Lipiarmycin A3
Lipiarrmycin
OPT-80
OPT-80;PAR-101;Clostomicin B1;Tiacumicin B
PAR 01
PAR-101
Q5446672
R-Tiacumicin B
S-7827
SCHEMBL10000818
Tiacumicin B
UNII-Z5N076G8YQ
Z5N076G8YQ
Paragraph IV (Patent) Challenges for DIFICID
Tradename Dosage Ingredient NDA Submissiondate
DIFICID TABLET;ORAL fidaxomicin 201699 2015-05-27

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 FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DIFICID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539977 C 2015 015 Romania   Start Trial PRODUCT NAME: FIDAXOMICIN; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF NATIONAL AUTHORISATION: 20111205; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001, EU/1/11/733/002, EU/1/11/733/003, EU/1/11/733/004; DATE OF FIRST AUTHORISATION IN EEA: 20111205
1539977 300727 Netherlands   Start Trial PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
1539977 92684 Luxembourg   Start Trial PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Colorcon
Medtronic
Baxter
Dow

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 verification 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.