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Generated: November 13, 2018

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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
Generic Entry Date for 201699*:
Constraining patent/regulatory exclusivity:
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
Ingredient-typeMacrolides
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:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 27, 2011TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 31, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jul 31, 2027Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Mar 4, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MICROBIAL INFECTIONS

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