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
Summary for DIFICID
International Patents: | 159 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 23 |
Clinical Trials: | 10 |
Patent Applications: | 1,006 |
Drug Prices: | Drug price information for DIFICID |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DIFICID |
What excipients (inactive ingredients) are in DIFICID? | DIFICID excipients list |
DailyMed Link: | DIFICID at DailyMed |


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
Sponsor | Phase |
---|---|
University of Alberta | Phase 2 |
McMaster University | Phase 3 |
Vancouver Island Health Authority | Phase 3 |
Pharmacology for DIFICID
Drug Class | Macrolide Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes 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 |