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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Johnson and Johnson
Novartis
Julphar
Healthtrust
Farmers Insurance
Federal Trade Commission
Accenture
Fuji

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205552

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NDA 205552 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Inc and is included in one NDA. It is available from one supplier. There are twenty-one patents protecting this drug and one Paragraph IV challenge. Additional details are available on the IMBRUVICA profile page.

The generic ingredient in IMBRUVICA is ibrutinib. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
Summary for 205552
Tradename:IMBRUVICA
Applicant:Pharmacyclics Inc
Ingredient:ibrutinib
Patents:21
Formulation / Manufacturing:see details
Pharmacology for NDA: 205552
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 205552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMBRUVICA ibrutinib CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-070 57962-070-28 28 CAPSULE in 1 BOTTLE, PLASTIC (57962-070-28)
IMBRUVICA ibrutinib CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-140 57962-140-09 90 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG
Approval Date:Nov 13, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 2, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Jan 18, 2020
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:May 6, 2019
Regulatory Exclusivity Use:DOSING RECOMMENDATION ADDED TO THE LABELING FOR IMBRUVICA USE IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LEUKEMIA (SLL)

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
US Army
Dow
Harvard Business School
UBS
Express Scripts
Mallinckrodt
Medtronic

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 verifification 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.

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