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Last Updated: October 17, 2019

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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 sixteen patent family members in twenty-eight 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
Drug Prices for DIFICID

See drug prices 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.

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.2015-08-31
MERCK SHARP & DOHME CORP. v. ACTAVIS LABORATORIES FL, INC.

See all DIFICID litigation

Pharmacology for DIFICID
Synonyms for DIFICID
55352-58-4
56645-60-4
750595-89-2
873857-62-6
AK402701
BRN 5228707
CHEMBL1255800
Clostomicin B1
Clostomycin B1
Dificlir
Difimicin
FI8
Fidaxomicin
Fidaxomicin (Dificid)
Fidaxomicin [USAN:INN]
Fidaxomicin, >=98% (HPLC)
fidaxomicin/Dificid
Lipiarmycin
Lipiarmycin A 3
Lipiarmycin A3
OPT-80
PAR 01
PAR-101
R-Tiacumicin B
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   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes   Start Trial   Start Trial Y 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
Paragraph IV (Patent) Challenges for DIFICID
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 200 mg ➤ Subscribe   Start Trial

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 92684 Luxembourg   Start Trial PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20111207
1539977 CA 2015 00020 Denmark   Start Trial PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
1539977 16/2015 Austria   Start Trial PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
1539977 CR 2015 00020 Denmark   Start Trial PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
1539977 122015000026 Germany   Start Trial PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Baxter
AstraZeneca
Boehringer Ingelheim

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