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-eight patent family members in forty-three 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
Summary for VENCLEXTA
International Patents: | 258 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 183 |
Patent Applications: | 1,528 |
Drug Prices: | Drug price information for VENCLEXTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VENCLEXTA |
What excipients (inactive ingredients) are in VENCLEXTA? | VENCLEXTA excipients list |
DailyMed Link: | VENCLEXTA at DailyMed |
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
Sponsor | Phase |
---|---|
Peter MacCallum Cancer Centre, Australia | Phase 2 |
Northwestern University | Phase 1 |
Weill Medical College of Cornell University | Phase 2 |
Pharmacology for VENCLEXTA
Drug Class | BCL-2 Inhibitor |
Mechanism of Action | P-Glycoprotein Inhibitors |
Physiological Effect | Increased Cellular Death |
Anatomical Therapeutic Chemical (ATC) Classes for VENCLEXTA
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 | ||||
Abbvie | VENCLEXTA | venetoclax | TABLET;ORAL | 208573-002 | Apr 11, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 | ||||
>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 |
---|---|---|---|
South Korea | 20150048886 | COMBINATION THERAPY OF A TYPE II ANTI-CD20 ANTIBODY WITH A SELECTIVE BCL-2 INHIBITOR | ⤷ Try a Trial |
Ecuador | SP13012647 | DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS | ⤷ Try a Trial |
Hong Kong | 1163099 | 用於治療癌症及免疫及自體免疫疾病之細胞凋亡誘發劑 (APOPTOSIS-INDUCING AGENTS FOR THE TREATMENT OF CANCER AND IMMUNE AND AUTOIMMUNE DISEASES) | ⤷ Try a Trial |
Ecuador | SP12012349 | AGENTES INDUCTORES DE APOPTOSIS CONTRA EL CÁNCER Y DE ENFERMEDADES INMUNES Y AUTOINMUNES | ⤷ Try a Trial |
Brazil | 112012029923 | agentes que induzem apoptose para o tratamento de câncer e doenças imunes e autoimunes | ⤷ Try a Trial |
South Korea | 20230128571 | 암,면역 질환 및 자가면역 질환의 치료를 위한 아폽토시스-유도제 (- Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases) | ⤷ Try a Trial |
Mexico | 2019012154 | 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.) | ⤷ 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 | PA2017015,C2435432 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VENETOKLAKSAS; REGISTRATION NO/DATE: EU/1/16/1138 20161205 |
2435432 | 1790021-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138 20161207 |
2435432 | CR 2017 00021 | Denmark | ⤷ Try a Trial | PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138/001-007 20161207 |
2435432 | 132017000054735 | Italy | ⤷ Try a Trial | PRODUCT NAME: VENETOCLAX(VENCLYXTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1138, 20161207 |
2435432 | 17C1018 | France | ⤷ Try a Trial | PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207 |
2435432 | C20170017 00231 | Estonia | ⤷ Try a Trial | PRODUCT NAME: VENETOKLAKS;REG NO/DATE: EU/1/16/1138 07.12.2016 |
2435432 | 386 50008-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: VENETOKLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |