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Last Updated: April 13, 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
>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
Hungary E041421 ⤷  Try a Trial
Poland 2125850 ⤷  Try a Trial
Spain 2821384 ⤷  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 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 CR 2015 00020 Denmark ⤷  Try a Trial PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
1539977 C201530022 Spain ⤷  Try a Trial PRODUCT NAME: FIDAXOMICINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/733/001-004; DATE OF AUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/733/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20111207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.