➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Merck
AstraZeneca
Boehringer Ingelheim
Mallinckrodt
Express Scripts

Last Updated: January 24, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210563

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 210563 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are thirty-eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the IMBRUVICA profile page.

The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen 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 210563
Tradename:IMBRUVICA
Applicant:Pharmacyclics Inc
Ingredient:ibrutinib
Patents:34
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 210563
Generic Entry Date for 210563*:
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: 210563
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 210563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMBRUVICA ibrutinib TABLET;ORAL 210563 NDA Pharmacyclics LLC 57962-014 57962-014-28 1 BLISTER PACK in 1 CARTON (57962-014-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK
IMBRUVICA ibrutinib TABLET;ORAL 210563 NDA Pharmacyclics LLC 57962-280 57962-280-28 1 BLISTER PACK in 1 CARTON (57962-280-28) > 28 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 210563
Tradename Dosage Ingredient NDA Submissiondate
IMBRUVICA TABLET;ORAL ibrutinib 210563 2018-12-14
IMBRUVICA TABLET;ORAL ibrutinib 210563 2018-11-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength140MG
Approval Date:Feb 16, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 24, 2021
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Jan 25, 2022
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Jun 3, 2031Product Flag?Substance Flag?Delist Request?

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Boehringer Ingelheim
Harvard Business School
Baxter
McKinsey

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.