Pharsight

1. List of Venclexta drug patents

Application	Filing Date	Opposition Party	Legal Status
EP11791401A	2018-05-30	Generics (U.K.) Limited	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US11110087	October, 2022	PO preliminary response filed	Genentech, Inc. et al.	Dr. Reddy's Laboratories, Inc. et al.
US10993942	February, 2022	Trial Instituted	Genentech, Inc. et al.	Dr. Reddy's Laboratories, Inc. et al.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8546399	ABBVIE INC	Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases	Jun, 2031 (8 years from now)
US10730873	ABBVIE INC	Salts and crystalline forms of an apoptosis-inducing agent	Nov, 2031 (8 years from now)
US8722657	ABBVIE INC	Salts and crystalline forms of an apoptosis-inducing agent	Jan, 2032 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9174982	ABBVIE INC	Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases	May, 2030 (7 years from now)
US11369599	ABBVIE INC	Melt-extruded solid dispersions containing an apoptosis-inducing agent	May, 2032 (9 years from now)
US11110087	ABBVIE INC	Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor	Sep, 2033 (10 years from now)
US10993942	ABBVIE INC	Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor	Sep, 2033 (10 years from now)
US11413282	ABBVIE INC	Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor	Sep, 2033 (10 years from now)
US9539251	ABBVIE INC	Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor	Sep, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	May 15, 2026
M (M)	Oct 16, 2023

Market Authorisation Date: 11 April, 2016

Treatment: Treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll); Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (aml) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; Treatment of patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll), with or without 17p deletion, who have received at least one prior therapy; Treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll), with or without 17p deletion, who have received at least one prior therapy; Treatment of acute myeloid leukemia (aml) by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine in adults 75 years or older or having certain comorbidities according to a dose ramp-up including a 100 mg per day dose; Treatment of chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) by orally administering venetoclax to an adult according to a dose ramp-up including a 100 mg per day dose; Treatment of chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week; Treatment of adults with relapsed, refractory or previously untreated chronic lymphocytic leukemia including a dose ramp-up and in combination with obinutuzumab in multiple 28-day dosing cycles followed by administration in absence of obinutuzumab; Treatment of adult patients with chronic lymphocytic leukemia (cll) or small lymphocytic leukemia (sll) in combination with a ga101 antibody such as obinutuzumab for one or more dosing periods, wherein the cll or sll is a cd20-expressing cancer

Dosage: TABLET;ORAL