Flexible Subscriptions to Match your Budget and Timeline See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Express Scripts
Colorcon
McKesson
Harvard Business School

Last Updated: December 1, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 213138


Email this page to a colleague

« Back to Dashboard

NDA 213138 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 213138
Tradename:DIFICID
Applicant:Cubist Pharms Llc
Ingredient:fidaxomicin
Patents:6
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 213138
Generic Entry Date for 213138*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;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: 213138
Suppliers and Packaging for NDA: 213138
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIFICID fidaxomicin FOR SUSPENSION;ORAL 213138 NDA Merck Sharp & Dohme Corp. 52015-700 52015-700-22 1 POUCH in 1 CARTON (52015-700-22) > 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) > 150 mL in 1 BOTTLE, GLASS (52015-700-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/ML
Approval Date:Jan 24, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 24, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jul 24, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:⤷  Try it FreePatent Expiration:Jan 31, 2028Product Flag?Substance Flag?Delist Request?Y

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Medtronic
McKinsey
Merck
Express Scripts

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.