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Last Updated: September 28, 2021

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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 two NDAs. It is available from one supplier. There are six 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
Applicant:Cubist Pharms Llc
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 201699
Generic Entry Date for 201699*:
Constraining patent/regulatory exclusivity:

*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
Paragraph IV (Patent) Challenges for 201699
Tradename Dosage Ingredient NDA Submissiondate
DIFICID TABLET;ORAL fidaxomicin 201699 2015-05-27

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 27, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 24, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jul 24, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Free Forever TrialPatent Expiration:Jan 31, 2028Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.