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Details for New Drug Application (NDA): 201699

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NDA 201699 describes DIFICID, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DIFICID profile page.

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 201699

Tradename:	DIFICID
Applicant:	Cubist Pharms Llc
Ingredient:	fidaxomicin
Patents:	5

Generic Entry Opportunity Date for 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 NDA: 201699

Suppliers and Packaging for NDA: 201699

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIFICID	fidaxomicin	TABLET;ORAL	201699	NDA	Merck Sharp & Dohme Corp.	52015-080	52015-080-01	1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	May 27, 2011	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jul 31, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Jul 31, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Mar 4, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF MICROBIAL INFECTIONS

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