DrugPatentWatch Database Preview

DIFICID Drug Profile

« Back to Dashboard

When do Dificid patents expire, and what generic alternatives are available?

Dificid is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one patent family members in twenty-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.

Summary for DIFICID

International Patents:	101
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	9
Patent Applications:	23
Drug Prices:	Drug price information for DIFICID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DIFICID
DailyMed Link:	DIFICID at DailyMed

Generic Entry Opportunity Date for DIFICID

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.

Pharmacology for DIFICID

Drug Class

Macrolide Antibacterial

Synonyms for DIFICID

(2R,3S,4S,5S,6R)-6-{[(3E,5E,8S,9E,11S,12R,13E,15E,18S)-12-{[(2R,3S,4R,5S)-3,4-dihydroxy-6,6-dimethyl-5-[(2-methylpropanoyl)oxy]oxan-2-yl]oxy}-11-ethyl-8-hydroxy-18-[(1R)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctad

55352-58-4

56645-60-4

750595-89-2

873857-62-6

BRN 5228707

CHEMBL1255800

Clostomicin B1

Clostomycin B1

D06LNW

Dificid (TN)

Dificlir

Difimicin

Fidaxomicin

Fidaxomicin (Dificid)

Fidaxomicin [USAN:INN]

Fidaxomicin, >=98% (HPLC)

fidaxomicin/Dificid

Lipiarmicin

Lipiarmycin

Lipiarmycin A 3

Lipiarmycin A3

OPT-80

PAR 01

PAR-101

R-Tiacumicin B

RTECS OQ7378000

S-7827

SCHEMBL10000818

Tiacumicin B

UNII-Z5N076G8YQ

Z5N076G8YQ

US Patents and Regulatory Information for 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	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes			Y	Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes			Y	Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes			Y	Y

Paragraph IV (Patent) Challenges for DIFICID

Drugname	Dosage	Strength	RLD	Date
	Tablets	200 mg

International Patents for DIFICID

Country	Document Number	Estimated Expiration
European Patent Office	2125850
Japan	2005534332
European Patent Office	1848273
Spain	2527052
China	101663312

Supplementary Protection Certificates for DIFICID

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2015	Austria		PRODUCT NAME: FIDAXOMICIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/733/001 - 004 (MITTEILUNG) 20111207
0727	Netherlands		PRODUCT NAME: FIDAXOMICINE; REGISTRATION NO/DATE: EU/1/11/733/001-004 20111207
90020-2	Sweden		PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733 20111205
2015 00020	Denmark		PRODUCT NAME: FIDAXOMICIN; REG. NO/DATE: EU/1/11/733/001-004 20111207
2015 00020	Denmark		PRODUCT NAME: FIDAXOMICIN ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/11/733/001-004 20111205