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Last Updated: January 28, 2023

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-nine 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® 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 three 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

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DIFICID
Generic Entry Dates for DIFICID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
FOR SUSPENSION;ORAL
Generic Entry Dates 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
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 seven US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DIFICID is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting DIFICID

Polymorphic crystalline forms of tiacumicin B
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

18-membered macrocycles and analogs thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

18-membered macrocycles and analogs thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

18-membered macrocycles and analogs thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Composition of tiacumicin compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting DIFICID

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC PATIENTS AGED 6 MONTHS AND OLDER FOR THE TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA (CDAD)
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138-001 Jan 24, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Cubist Pharms Llc DIFICID fidaxomicin TABLET;ORAL 201699-001 May 27, 2011 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: 6024
Estimated Expiration: See Plans and Pricing

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
Poland 2305245 See Plans and Pricing
Mexico 340742 COMPUESTOS MACROCICLICOS DE 18 MIEMBROS Y ANALOGOS DE LOS MISMOS. (18-MEMBERED MACROCYCLES AND ANALOGS THEREOF.) See Plans and Pricing
Portugal 2305245 See Plans and Pricing
Canada 2626698 METHODE DE TRAITEMENT D'UNE DIARRHEE ASSOCIEE A CLOSTRIDIUM DIFFICILE (METHOD OF TREATING CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DIFICID

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1539977 300727 Netherlands See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1539977 92684 Luxembourg See Plans and Pricing PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/733/001-002-004 - DIFICLIR
1539977 C 2015 015 Romania See Plans and Pricing 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 CR 2015 00020 Denmark See Plans and Pricing PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.