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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-eight patent family members in thirty-five 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:	158
US Patents:	6
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	10
Patent Applications:	866
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	NDA	Submissiondate
DIFICID	TABLET;ORAL	fidaxomicin	201699	2015-05-27

US Patents and Regulatory Information for DIFICID

DIFICID is protected by seven US patents and three 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
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes

International Patents for DIFICID

Country	Patent Number	Estimated Expiration
Japan	2009512691
Slovenia	2125850
Spain	2395404
European Patent Office	2945613
New Zealand	710875

Supplementary Protection Certificates for DIFICID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1539977	16/2015	Austria		PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
1539977	SPC/GB15/020	United Kingdom		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	2015/019	Ireland		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	92684	Luxembourg		PRODUCT NAME: FIDAXOMICINE OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/11/733/001-002-004 - DIFICLIR
1539977	C20150013 00220	Estonia		PRODUCT NAME: FIDAKSOMITSIIN;REG NO/DATE: EU/1/11/733 07.12.2011