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Last Updated: December 23, 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-nine 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

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Drug patent expirations by year for venclexta
Drug Prices for venclexta

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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
Antonio M Jimenez JimenezPhase 1
Montefiore Medical CenterPhase 1
Flamingo Therapeutics NVPhase 1

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 ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-002 Apr 11, 2016 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie VENCLEXTA venetoclax TABLET;ORAL 208573-003 Apr 11, 2016 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
>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
Patent: DISPERSIONES SOLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS, PROCESO PARA PREPARAR, METODO DE TRATAMIENTO
Estimated Expiration: ⤷  Subscribe

Patent: 2475
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 11361704
Patent: Melt-extruded solid dispersions containing an apoptosis-inducing agent
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2013010524
Patent: dispersões sólidas extrusadas por fusão contendo um agente indutor de apoptose
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 13985
Patent: DISPERSIONS SOLIDES EXTRUDEES EN FUSION CONTENANT UN AGENT INDUISANT L'APOPTOSE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 13001120
Patent: 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.
Estimated Expiration: ⤷  Subscribe

China

Patent: 3282025
Patent: Melt-extruded solid dispersions containing an apoptosis-nducing agent
Estimated Expiration: ⤷  Subscribe

Patent: 8175749
Patent: 含有细胞凋亡诱导剂的熔体挤出的固体分散体 (Melt-extruded solid dispersions containing apoptosis-inducing agent)
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 81472
Patent: Dispersiones sólidas extruidas por fusión que contienen un agente inductor de apoptosis
Estimated Expiration: ⤷  Subscribe

Costa Rica

Patent: 130224
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Patent: 180289
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS (Divisional 2013-0224)
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0171884
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 19993
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 13769
Estimated Expiration: ⤷  Subscribe

Dominican Republic

Patent: 013000092
Patent: DISPERSIONES SOLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE ADOPTOSIS
Estimated Expiration: ⤷  Subscribe

Patent: 017000003
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 13012647
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Patent: 22086925
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 13769
Patent: DISPERSIONS SOLIDES EXTRUDÉES EN FUSION CONTENANT UN AGENT INDUISANT L'APOPTOSE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Patent: 19308
Patent: DISPERSIONS SOLIDES EXTRUDÉES PAR FUSION CONTENANT UN AGENT INDUISANT L'APOPTOSE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Patent: 18731
Patent: DISPERSIONS SOLIDES EXTRUDÉES À L'ÉTAT FONDU CONTENANT UN AGENT INDUISANT L'APOPTOSE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Guatemala

Patent: 1300102
Patent: DISPERSIONES SOLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 43761
Patent: 含有細胞凋亡誘導劑的熔體擠出的固體分散體 (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 35169
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 6215
Patent: דיספרסיות מוצקות מהתכה ושיחול המכילות חומר המשרה מוות מתוכנן של תאים (Melt-extruded solid dispersions containing an apoptosis-inducing agent)
Estimated Expiration: ⤷  Subscribe

Patent: 1877
Patent: דיספרסיות מוצקות מהתכה ושיחול המכילות חומר המשרה מוות מתוכנן של תאים (Melt-extruded solid dispersions containing an apoptosis-inducing agent)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 02187
Estimated Expiration: ⤷  Subscribe

Patent: 53638
Estimated Expiration: ⤷  Subscribe

Patent: 13544804
Estimated Expiration: ⤷  Subscribe

Patent: 16147878
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 13769
Estimated Expiration: ⤷  Subscribe

Malaysia

Patent: 9224
Patent: MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 5603
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS. (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT.)
Estimated Expiration: ⤷  Subscribe

Patent: 2113
Patent: DISPERSIONES SOLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS. (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT.)
Estimated Expiration: ⤷  Subscribe

Patent: 13004843
Patent: DISPERSIONES EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS. (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT.)
Estimated Expiration: ⤷  Subscribe

Montenegro

Patent: 942
Patent: KRUTA DISPERZIJA DOBIVENA EKSTRUZIJOM U RASTALJENOM STANJU KOJA SADRŽAVA AGENS ZA INDUCIRANJE APOPTOZE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 8907
Patent: Melt-extruded solid dispersions containing an apoptosis-inducing agent
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 13769
Estimated Expiration: ⤷  Subscribe

Peru

Patent: 140381
Patent: DISPERSIONES SOLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Patent: 171242
Patent: DISPERSIONES SOLIDAS EXTRUIDAS POR FUSION QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 13769
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 13769
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 77859
Patent: ПОЛУЧЕННЫЕ ЭКСТРУЗИЕЙ РАСПЛАВА ТВЕРДЫЕ ДИСПЕРСИИ, СОДЕРЖАЩИЕ ИНДУЦИРУЮЩЕЕ АПОПТОЗ СРЕДСТВО (SOLID DISPERSIONS PRODUCED BY MELT EXTRUSION AND CONTAINING APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Patent: 33353
Patent: ПОЛУЧЕННЫЕ ЭКСТРУЗИЕЙ РАСПЛАВА ТВЕРДЫЕ ДИСПЕРСИИ, СОДЕРЖАЩИЕ ИНДУЦИРУЮЩЕЕ АПОПТОЗ СРЕДСТВО (SOLID DISPERSIONS PRODUCED BY MELT EXTRUSION AND CONTAINING APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Patent: 13124823
Patent: ПОЛУЧЕННЫЕ ЭКСТРУЗИЕЙ ТВЕРДЫЕ ДИСПЕРСИИ, СОДЕРЖАЩИЕ ИНДУЦИРУЮЩЕЕ АПАПТОЗ СРЕДСТВО
Estimated Expiration: ⤷  Subscribe

Serbia

Patent: 718
Patent: RASTOPOM-EKSTRUDIRANE ČVRSTE DISPERZIJE KOJE SADRŽE AGENS KOJI INDUKUJE APOPTOZU (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 9477
Patent: MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT
Estimated Expiration: ⤷  Subscribe

Patent: 14015077
Patent: MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 13769
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1302669
Patent: MELT-EXTRUDED SOLID DISPESIONS CONTAINING AN APOPTOSIS-INDUCING AGENT
Estimated Expiration: ⤷  Subscribe

Patent: 1401440
Patent: PROCESS FOR PREPARING A SOLID DISPERSION CONTAINING AN APOPTOSIS-INDUCING AGENT
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1836820
Estimated Expiration: ⤷  Subscribe

Patent: 1957137
Estimated Expiration: ⤷  Subscribe

Patent: 140052921
Patent: MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT
Estimated Expiration: ⤷  Subscribe

Patent: 180024025
Patent: 아폽토시스―유도제를 포함하는 용융―압출된 고체 분산체 (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 47583
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 35699
Estimated Expiration: ⤷  Subscribe

Patent: 48261
Estimated Expiration: ⤷  Subscribe

Patent: 1242946
Patent: Melt-extruded solid dispersions containing an apoptosis-inducing agent
Estimated Expiration: ⤷  Subscribe

Patent: 1636324
Patent: Melt-extruded solid dispersions containing an apoptosis-inducing agent
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 3500
Patent: ОДЕРЖАНІ ЕКСТРУЗІЄЮ РОЗПЛАВУ ТВЕРДІ ДИСПЕРСІЇ, ЩО МІСТЯТЬ ІНДУКУЮЧИЙ АПОПТОЗ ЗАСІБ
Estimated Expiration: ⤷  Subscribe

Uruguay

Patent: 692
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Patent: 326
Patent: DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS
Estimated Expiration: ⤷  Subscribe

Patent: 192
Patent: DISPERSIÓN SÓLIDA, PROCESO PARA PREPARARLA Y FORMA DE DOSIFICACIÓN FARMACÉUTICA SUMINISTRABLE POR VÍA ORAL QUE LA COMPRENDE
Estimated Expiration: ⤷  Subscribe

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
Uruguay 33047 AGENTES INDUCTORES DE APOPTOSIS PARA EL TRATAMIENTO DEL CÁNCER Y DE ENFERMEDADES INMUNES Y AUTOINMUNES ⤷  Subscribe
Canada 2813985 DISPERSIONS SOLIDES EXTRUDEES EN FUSION CONTENANT UN AGENT INDUISANT L'APOPTOSE (MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT) ⤷  Subscribe
Costa Rica 20180289 DISPERSIONES SÓLIDAS EXTRUIDAS POR FUSIÓN QUE CONTIENEN UN AGENTE INDUCTOR DE APOPTOSIS (Divisional 2013-0224) ⤷  Subscribe
New Zealand 595708 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for venclexta

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435432 1790021-8 Sweden ⤷  Subscribe PRODUCT NAME: VENETOCLAX; REG. NO/DATE: EU/1/16/1138 20161207
2435432 21/2017 Austria ⤷  Subscribe PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 (MITTEILUNG) 20161207
2435432 132017000054735 Italy ⤷  Subscribe PRODUCT NAME: VENETOCLAX(VENCLYXTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1138, 20161207
2435432 300873 Netherlands ⤷  Subscribe PRODUCT NAME: VENETOCLAX; REGISTRATION NO/DATE: EU/1/16/1138 20161207
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Venclexta Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VENCLEXTA

Introduction

VENCLEXTA (venetoclax), a BCL-2 inhibitor, has been a significant player in the oncology market since its approval for the treatment of certain blood cancers. Developed by AbbVie and Roche's Genentech unit, VENCLEXTA has shown promising growth and is poised to continue its impact in the cancer treatment landscape.

Mechanism of Action and Clinical Significance

VENCLEXTA works by inhibiting the BCL-2 protein, which is often overexpressed in cancer cells, particularly in chronic lymphocytic leukemia (CLL) and other hematologic malignancies. This inhibition leads to the apoptosis (programmed cell death) of cancer cells, providing a targeted approach to cancer treatment[3].

Regulatory Approvals and Designations

The drug received its first FDA approval in April 2016 for the treatment of relapsed or refractory CLL with a 17p deletion. Since then, it has received additional approvals and designations, including a breakthrough designation for the treatment of mantle-cell lymphoma in May 2024[1][3].

Market Performance and Revenue

VENCLEXTA has demonstrated strong financial performance. In 2023, it generated global sales of USD 2.2 billion, with a growth rate of approximately 14% year-over-year[1]. For the third quarter of 2024, global VENCLEXTA net revenues were $677 million, showing an increase of 14.8% on a reported basis and 18.2% on an operational basis[5].

Forecast and Growth Projections

The global venetoclax market is estimated to grow significantly, with a projected market size of USD 2.26 billion by 2032, up from USD 1.17 billion in 2023, at a CAGR of 12.92% during the forecast period (2024-2032)[4].

Regional Market Dynamics

North America dominates the global VENCLEXTA market, driven by a robust healthcare sector and rapid technological advancements. Europe is expected to be the second leading region, while Asia Pacific is anticipated to be the fastest-growing region due to the high prevalence of CLL and a large population base[4].

Competitive Landscape

VENCLEXTA faces competition from other oncology drugs, notably Imbruvica, which is also marketed by AbbVie. However, VENCLEXTA's unique mechanism of action and expanding indications are expected to strengthen AbbVie's presence in the oncology market[3].

Pipeline and Future Developments

Several BCL-2 inhibitors are in the pipeline, including Sonrotoclax (BGB-11417) and ICP-248, which are being developed by companies like BeiGene and innoCare, respectively. These developments are expected to further enhance the treatment options for hematologic malignancies[1].

Safety and Efficacy

One of the significant challenges in the development of VENCLEXTA was managing the risk of tumor lysis syndrome, a condition that arises from the rapid death of cancer cells. AbbVie implemented an escalating dose schedule to mitigate this risk, although adverse effects such as tumor lysis, pneumonia, and low blood cell counts were still reported in clinical trials[3].

Financial Impact on AbbVie

VENCLEXTA's success has been a key contributor to AbbVie's financial performance. The drug's growth has helped offset declines in other areas, such as the loss of exclusivity for Humira. In the full-year 2023 financial results, VENCLEXTA's net revenues increased by 14.3% on a reported basis, contributing significantly to AbbVie's overall revenue[2].

Market Expansion and Collaborations

To extend the use of VENCLEXTA into other hematological cancers, AbbVie and its partners are collaborating on various clinical trials. For instance, a combination of VENCLEXTA and Rituxan is being explored for the treatment of relapsed/refractory CLL[3].

Patient Impact and Market Demand

The demand for VENCLEXTA is driven by the increasing incidence of blood cancers. According to the Leukemia Research Foundation, over 201,870 new cases of blood cancer are expected in the U.S., highlighting the need for effective treatments like VENCLEXTA[4].

Conclusion

VENCLEXTA has established itself as a crucial drug in the treatment of blood cancers, with a strong financial trajectory and promising market dynamics. Its unique mechanism of action, expanding indications, and robust pipeline of related BCL-2 inhibitors position it for continued growth and impact in the oncology market.

Key Takeaways

  • Strong Financial Performance: VENCLEXTA generated USD 2.2 billion in global sales in 2023 with a 14% year-over-year growth rate.
  • Regulatory Approvals: Received breakthrough designation for mantle-cell lymphoma and approvals for CLL and other hematologic malignancies.
  • Market Growth Projections: Expected to reach USD 2.26 billion by 2032 at a CAGR of 12.92%.
  • Regional Dominance: North America leads, with Europe and Asia Pacific showing significant growth potential.
  • Competitive Landscape: Faces competition from Imbruvica but maintains a strong position due to its unique mechanism.
  • Pipeline Developments: Several BCL-2 inhibitors are in development, enhancing treatment options.
  • Safety and Efficacy: Managed tumor lysis syndrome risk through an escalating dose schedule.

FAQs

Q: What is the primary mechanism of action of VENCLEXTA? A: VENCLEXTA works by inhibiting the BCL-2 protein, leading to the apoptosis of cancer cells.

Q: What were the global sales of VENCLEXTA in 2023? A: VENCLEXTA generated global sales of USD 2.2 billion in 2023.

Q: What is the projected market size of VENCLEXTA by 2032? A: The global venetoclax market is estimated to reach USD 2.26 billion by 2032.

Q: Which regions are expected to drive the growth of the VENCLEXTA market? A: North America, Europe, and Asia Pacific are expected to be key drivers of market growth.

Q: What are some of the challenges faced during the development of VENCLEXTA? A: Managing the risk of tumor lysis syndrome was a significant challenge, addressed through an escalating dose schedule.

Sources

  1. GlobeNewswire - Game-Changing BCL-2 Inhibitors Set to Revolutionize Cancer Treatment Market[1].
  2. AbbVie Investors - AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results[2].
  3. BioPharma Dive - Inside the development of Venclexta, AbbVie's new leukemia drug[3].
  4. Straits Research - Venetoclax Market Size, Share, Trend and Forecast to 2032[4].
  5. AbbVie Investors - AbbVie Reports Third-Quarter 2024 Financial Results[5].

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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.