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Last Updated: March 30, 2023

Details for Patent: 10,016,435


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Which drugs does patent 10,016,435 protect, and when does it expire?

Patent 10,016,435 protects IMBRUVICA and is included in two NDAs.

Protection for IMBRUVICA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-five patent family members in seventeen countries.

Summary for Patent: 10,016,435
Title:Use of inhibitors of Bruton's tyrosine kinase (Btk)
Abstract: Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Inventor(s): Buggy; Joseph J. (Mountain View, CA), Elias; Laurence (Berkeley, CA), Fyfe; Gwen (San Francisco, CA), Hedrick; Eric (Summit, NJ), Loury; David J. (Incline Village, NV), Mody; Tarak D. (Sunnyvale, CA)
Assignee: Pharmacyclics LLC (Sunnyvale, CA)
Application Number:15/715,995
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,016,435
Patent Claim Types:
see list of patent claims
Use; Dosage form;

Drugs Protected by US Patent 10,016,435

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,016,435

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011261185 ⤷  Sign Up
Australia 2015275321 ⤷  Sign Up
Australia 2018204179 ⤷  Sign Up
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Harvard Business School
Moodys
Merck
Express Scripts

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