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Last Updated: January 24, 2021

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Details for New Drug Application (NDA): 210563

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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
Applicant:Pharmacyclics Inc
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 210563
Generic Entry Date for 210563*:
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: 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?

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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Harvard Business School

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