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Last Updated: October 1, 2022

VENCLEXTA Drug Patent Profile


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Which patents cover Venclexta, and when can generic versions of Venclexta launch?

Venclexta is a drug marketed by Abbvie Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-nine patent family members in forty-two countries.

The generic ingredient in VENCLEXTA is venetoclax. One supplier is listed for this compound. Additional details are available on the venetoclax profile page.

DrugPatentWatch® Generic Entry Outlook for Venclexta

Venclexta was eligible for patent challenges on April 11, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2032. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for VENCLEXTA
Drug Prices for VENCLEXTA

See drug prices for VENCLEXTA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VENCLEXTA
Generic Entry Date for VENCLEXTA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for VENCLEXTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jacqueline Garcia, MDPhase 1
Sandy Wong, MDPhase 1/Phase 2
Janssen PharmaceuticalsPhase 1/Phase 2

See all VENCLEXTA clinical trials

Pharmacology for VENCLEXTA
Drug ClassBCL-2 Inhibitor
Mechanism of Action P-Glycoprotein Inhibitors
Physiological Effect Increased Cellular Death
Paragraph IV (Patent) Challenges for VENCLEXTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VENCLEXTA Tablets venetoclax 10 mg, 50 mg and 100 mg 208573 2 2020-04-13

US Patents and Regulatory Information for VENCLEXTA

VENCLEXTA is protected by twelve US patents and six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VENCLEXTA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VENCLEXTA

Salts and crystalline forms of an apoptosis-inducing agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Melt-extruded solid dispersions containing an apoptosis-inducing agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts and crystalline forms of an apoptosis-inducing agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)

Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: 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

FDA Regulatory Exclusivity protecting VENCLEXTA

TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION, AS DETECTED BY AN FDA APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE 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
Exclusivity Expiration: See Plans and Pricing

INDICATED IN COMBO WITH AZACITIDINE, OR DECITABINE, OR LOW-DOSE CYTARABINE FOR THE TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA IN ADULTS WHO ARE AGE 75 YEARS OR OLDER, OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
Exclusivity Expiration: See Plans and Pricing

VENETOCLAX IN COMBINATION WITH OBINUTUZUMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: See Plans and Pricing

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY M15-656 (VIALE-A) AND M16-043 (VIALE-C) TO SUPPORT PMR 3545-1 AND PMR 3545-2
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbvie Inc VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for VENCLEXTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AbbVie Deutschland GmbH Co. KG Venclyxto venetoclax EMEA/H/C/004106
Venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1)., , Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy., , Venclyxto monotherapy is indicated for the treatment of CLL:, - in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or, - in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor., , Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.,
Authorised no no no 2016-12-04
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for VENCLEXTA

When does loss-of-exclusivity occur for VENCLEXTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3656
Estimated Expiration: See Plans and Pricing

Australia

Patent: 11361704
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013010524
Estimated Expiration: See Plans and Pricing

Canada

Patent: 13985
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13001120
Estimated Expiration: See Plans and Pricing

China

Patent: 3282025
Estimated Expiration: See Plans and Pricing

Patent: 8175749
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 81472
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 130224
Estimated Expiration: See Plans and Pricing

Patent: 180289
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171884
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19993
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 13769
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 013000092
Estimated Expiration: See Plans and Pricing

Patent: 017000003
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 13012647
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 13769
Estimated Expiration: See Plans and Pricing

Patent: 19308
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1300102
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 43761
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 35169
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6215
Estimated Expiration: See Plans and Pricing

Patent: 1877
Estimated Expiration: See Plans and Pricing

Japan

Patent: 02187
Estimated Expiration: See Plans and Pricing

Patent: 53638
Estimated Expiration: See Plans and Pricing

Patent: 13544804
Estimated Expiration: See Plans and Pricing

Patent: 16147878
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 13769
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5603
Estimated Expiration: See Plans and Pricing

Patent: 2113
Estimated Expiration: See Plans and Pricing

Patent: 13004843
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 942
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8907
Estimated Expiration: See Plans and Pricing

Norway

Patent: 13769
Estimated Expiration: See Plans and Pricing

Peru

Patent: 140381
Estimated Expiration: See Plans and Pricing

Patent: 171242
Estimated Expiration: See Plans and Pricing

Poland

Patent: 13769
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 13769
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 77859
Estimated Expiration: See Plans and Pricing

Patent: 33353
Estimated Expiration: See Plans and Pricing

Patent: 13124823
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 718
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 9477
Estimated Expiration: See Plans and Pricing

Patent: 14015077
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 13769
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1302669
Estimated Expiration: See Plans and Pricing

Patent: 1401440
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1836820
Estimated Expiration: See Plans and Pricing

Patent: 1957137
Estimated Expiration: See Plans and Pricing

Patent: 140052921
Estimated Expiration: See Plans and Pricing

Patent: 180024025
Estimated Expiration: See Plans and Pricing

Spain

Patent: 47583
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 35699
Estimated Expiration: See Plans and Pricing

Patent: 48261
Estimated Expiration: See Plans and Pricing

Patent: 1242946
Estimated Expiration: See Plans and Pricing

Patent: 1636324
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 3500
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 692
Estimated Expiration: See Plans and Pricing

Patent: 326
Estimated Expiration: See Plans and Pricing

Patent: 192
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VENCLEXTA around the world.

Country Patent Number Title Estimated Expiration
Mexico 2011012257 AGENTES INDUCTORES DE APOTOSIS PARA EL TRATAMIENTO DE CANCER Y ENFERMEDADES INMUNES Y AUTOINMUNES. (APOPTOSIS-INDUCING AGENTS FOR THE TREATMENT OF CANCER AND IMMUNE AND AUTOIMMUNE DISEASES.) See Plans and Pricing
Israel 251877 דיספרסיות מוצקות מהתכה ושיחול המכילות חומר המשרה מוות מתוכנן של תאים (Melt-extruded solid dispersions containing an apoptosis-inducing agent) See Plans and Pricing
Chile 2013001120 Una dispersion solida que comprende un agente inductor de apoptosis de formula definida dispersado en una matriz solida que comprende a) al menos un vehiculo polimerico soluble en agua y b) al menos un surfactante; proceso de preparacion; forma de dosificacion oral, util para tratar una enfermedad neoplasica, inmune o autoinmune. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VENCLEXTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435432 300873 Netherlands See Plans and Pricing PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432 LUC00020 Luxembourg See Plans and Pricing PRODUCT NAME: VENETOCLAX (VENCLYXTO); AUTHORISATION NUMBER AND DATE: EU/1/16/1138 20161207
2435432 2017/023 Ireland See Plans and Pricing PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Mallinckrodt

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.