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Last Updated: March 19, 2024

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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 and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and fifty-six 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 Loss of Exclusivity (LOE) 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
Peter MacCallum Cancer Centre, AustraliaPhase 2
Northwestern UniversityPhase 1
Weill Medical College of Cornell UniversityPhase 2

See all VENCLEXTA clinical trials

Pharmacology for VENCLEXTA
Drug ClassBCL-2 Inhibitor
Mechanism of ActionP-Glycoprotein Inhibitors
Physiological EffectIncreased 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 fourteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VENCLEXTA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: 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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF AML BY ORALLY ADMINISTERING VENETOCLAX WITH AZACITIDINE OR DECITABINE OR LOW-DOSE CYTARABINE TO ADULTS 75 YEARS OR OLDER OR HAVING CERTAIN COMORBIDITIES PER A DOSE RAMP-UP INCLUDING AN INITIAL 100 MG OR A FINAL 400 MG PER DAY DOSE

Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Salts and crystalline forms of an apoptosis-inducing agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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

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: ⤷  Try a Trial

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: ⤷  Try a Trial

TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 2475
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11361704
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013010524
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 13985
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13001120
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3282025
Estimated Expiration: ⤷  Try a Trial

Patent: 8175749
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 81472
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 130224
Estimated Expiration: ⤷  Try a Trial

Patent: 180289
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0171884
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19993
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 013000092
Estimated Expiration: ⤷  Try a Trial

Patent: 017000003
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 13012647
Estimated Expiration: ⤷  Try a Trial

Patent: 22086925
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

Patent: 19308
Estimated Expiration: ⤷  Try a Trial

Patent: 18731
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1300102
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 43761
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 35169
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6215
Estimated Expiration: ⤷  Try a Trial

Patent: 1877
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 02187
Estimated Expiration: ⤷  Try a Trial

Patent: 53638
Estimated Expiration: ⤷  Try a Trial

Patent: 13544804
Estimated Expiration: ⤷  Try a Trial

Patent: 16147878
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 9224
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 5603
Estimated Expiration: ⤷  Try a Trial

Patent: 2113
Estimated Expiration: ⤷  Try a Trial

Patent: 13004843
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 942
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8907
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 140381
Estimated Expiration: ⤷  Try a Trial

Patent: 171242
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 77859
Estimated Expiration: ⤷  Try a Trial

Patent: 33353
Estimated Expiration: ⤷  Try a Trial

Patent: 13124823
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 718
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 9477
Estimated Expiration: ⤷  Try a Trial

Patent: 14015077
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 13769
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1302669
Estimated Expiration: ⤷  Try a Trial

Patent: 1401440
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1836820
Estimated Expiration: ⤷  Try a Trial

Patent: 1957137
Estimated Expiration: ⤷  Try a Trial

Patent: 140052921
Estimated Expiration: ⤷  Try a Trial

Patent: 180024025
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 47583
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 35699
Estimated Expiration: ⤷  Try a Trial

Patent: 48261
Estimated Expiration: ⤷  Try a Trial

Patent: 1242946
Estimated Expiration: ⤷  Try a Trial

Patent: 1636324
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 3500
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 692
Estimated Expiration: ⤷  Try a Trial

Patent: 326
Estimated Expiration: ⤷  Try a Trial

Patent: 192
Estimated Expiration: ⤷  Try a Trial

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
Costa Rica 20180289 DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS (Divisional 2013-0224) ⤷  Try a Trial
Australia 2015202183 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases ⤷  Try a Trial
Slovenia 2435432 ⤷  Try a Trial
Japan 2016147878 アポトーシス誘発剤を含む溶融押出固体分散体 (MELT-EXTRUDED SOLID DISPERSION CONTAINING APOPTOSIS-INDUCING AGENT) ⤷  Try a Trial
Dominican Republic P2017000003 DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VENCLEXTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435432 17C1018 France ⤷  Try a Trial PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
2435432 2017023 Norway ⤷  Try a Trial PRODUCT NAME: VENETOKLAKS, DVS. 4-(4-(2-(4-; REG. NO/DATE: EU/1/16/1138 20161213
2435432 PA2017015,C2435432 Lithuania ⤷  Try a Trial PRODUCT NAME: VENETOKLAKSAS; REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 2017/023 Ireland ⤷  Try a Trial PRODUCT NAME: VENETOCLAX (VENCLYXTO); REGISTRATION NO/DATE: EU/1/16/1138 20161205
2435432 300873 Netherlands ⤷  Try a Trial PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.