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Last Updated: March 19, 2024

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DIFICID Drug Patent 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 fifty-seven patent family members in thirty-six 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Dificid

A generic version of DIFICID was approved as fidaxomicin by ACTAVIS LABS FL on January 16th, 2024.

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Drug patent expirations by year for DIFICID
Drug Prices for DIFICID

See drug prices for DIFICID

Recent Clinical Trials for DIFICID

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

SponsorPhase
University of AlbertaPhase 2
McMaster UniversityPhase 3
Vancouver Island Health AuthorityPhase 3

See all DIFICID clinical trials

Pharmacology for DIFICID
Paragraph IV (Patent) Challenges for DIFICID
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DIFICID Tablets fidaxomicin 200 mg 201699 1 2015-05-27

US Patents and Regulatory Information for DIFICID

DIFICID is protected by six US patents and one FDA Regulatory Exclusivity.

Patents protecting DIFICID

Polymorphic crystalline forms of tiacumicin B
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

18-membered macrocycles and analogs thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

18-membered macrocycles and analogs thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Composition of tiacumicin compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting DIFICID

PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for DIFICID

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Tillotts Pharma GmbH Dificlir fidaxomicin EMEA/H/C/002087
Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.Dificlir granules for oral suspension is indicated for the treatment of Clostridioides  difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Authorised no no no 2011-12-05
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DIFICID

When does loss-of-exclusivity occur for DIFICID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 16024
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DIFICID around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2305245 Traitement de maladies consecutives a un traitement antibiotique (Treatment of diseases associated with the use of antibiotics) ⤷  Try a Trial
Japan 5166040 ⤷  Try a Trial
Mexico 340742 COMPUESTOS MACROCICLICOS DE 18 MIEMBROS Y ANALOGOS DE LOS MISMOS. (18-MEMBERED MACROCYCLES AND ANALOGS THEREOF.) ⤷  Try a Trial
Japan 5764168 ⤷  Try a Trial
Poland 2305244 ⤷  Try a Trial
South Korea 20080064177 METHOD OF TREATING CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA ⤷  Try a Trial
Cyprus 1121284 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIFICID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539977 C01539977/01 Switzerland ⤷  Try a Trial FUSION; FORMER OWNER: MERCK SHARP AND DOHME CORP., US
1539977 2015/019 Ireland ⤷  Try a Trial PRODUCT NAME: FIDAXOMICIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205; FIRST REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977 122015000026 Germany ⤷  Try a Trial PRODUCT NAME: FIDAXOMICIN; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111205
1539977 C20150013 00220 Estonia ⤷  Try a Trial PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011
1539977 CA 2015 00020 Denmark ⤷  Try a Trial PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205
1539977 SPC/GB15/020 United Kingdom ⤷  Try a Trial PRODUCT NAME: FIDAXOMICIN; REGISTERED: UK EU/1/11/733/001 20111207; UK EU/1/11/733/002 20111207; UK EU/1/11/733/003 20111207; UK EU/1/11/733/004 20111207
1539977 366 50006-2015 Slovakia ⤷  Try a Trial OWNER(S): MERCK SHARP & DOHME LLC, RAHWAY, NJ, US; PREDCHADZAJUCI MAJITEL: MERCK SHARP & DOHME CORP., RAHWAY, NJ, US; DATUM ZAPISU DO REGISTRA: 7.10.2022
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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