DIFICID Drug Patent Profile

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

See drug prices for DIFICID

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for DIFICID

NDA:

213138

Dosage:

FOR SUSPENSION;ORAL

NDA:

201699

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

See all DIFICID clinical trials

Pharmacology for DIFICID

Drug Class

Macrolide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for DIFICID

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

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.

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

FDA Regulatory Exclusivity protecting 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	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes					Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes					Y

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

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

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
Mexico	340742	COMPUESTOS MACROCICLICOS DE 18 MIEMBROS Y ANALOGOS DE LOS MISMOS. (18-MEMBERED MACROCYCLES AND ANALOGS THEREOF.)
Portugal	2305245
Canada	2626698	METHODE DE TRAITEMENT D'UNE DIARRHEE ASSOCIEE A CLOSTRIDIUM DIFFICILE (METHOD OF TREATING CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA)

Supplementary Protection Certificates for DIFICID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	300727	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1539977	92684	Luxembourg		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		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		PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207